Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-01-04 @ 8:18 AM
Study NCT ID:
NCT03468868
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2018-03-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparative Effectiveness Study Telerehab Versus Conventional
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'deborah.backus@shepherd.org', 'phone': '404-352-2020', 'title': 'Deborah Backus, PT, PhD', 'organization': 'Shepherd Center, Atlanta, GA'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from the time of consent through the end of the 16 week intervention phase.', 'description': 'During coaching sessions, the exercise coaches queried participants about any adverse events they experienced since the previous session. The site PI, study project manager, and study PI were notified of all AEs as they were reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Facility-based Rehabilitation', 'description': 'Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.', 'otherNumAtRisk': 198, 'deathsNumAtRisk': 198, 'otherNumAffected': 80, 'seriousNumAtRisk': 198, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG001', 'title': 'Telerehabilitation', 'description': 'Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.', 'otherNumAtRisk': 181, 'deathsNumAtRisk': 181, 'otherNumAffected': 88, 'seriousNumAtRisk': 181, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Coronavirus infection', 'notes': 'All were determined to be not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 8, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dental conditions', 'notes': 'Reported conditions included pain (2) and a fractured tooth (1). All were determined to be not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'notes': 'All were determined to be not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall with injury', 'notes': 'Injuries included minor skin abrasions, bruising, soreness, pain, sprain, fracture (3), and concussion (1). Of the 59 fall with injury events, 2 were determined to be possibly related, and 3 were determined to be related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 27, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 32, 'numAffected': 26}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall without injury', 'notes': 'Of the 44 fall without injury events, 3 were determined to be possibly related, and 8 were determined to be related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 22, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'notes': 'Of the 4 fatigue events, 1 was determined to be possibly related, and 1 was determined to be related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroenteritis', 'notes': 'All were determined to be not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General illness', 'notes': 'General illness included general, undiagnosed reports of feeling "sick". All were determined to be not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Heat intolerance', 'notes': 'Of the 3 heat intolerance events, 1 was determined to be possibly related, and 1 was determined to be related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza Infection', 'notes': 'All were determined to be not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Medication side effects', 'notes': 'All were determined to be not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine', 'notes': 'Of the 2 migraine events, 1 was determined to be possibly related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Motor Vehicle Accident (MVA) with Sequelae', 'notes': 'All were determined to be not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple Sclerosis (MS) Flare', 'notes': 'Of the 8 MS flare events, 1 was determined to be possibly related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Multiple Sclerosis (MS) Relapse', 'notes': 'Events were categorized as MS relapses only if diagnosed by a neurologist as such. All were determined to be not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological Symptoms', 'notes': 'Events included numbness (1), neuralgia (1), blurred vision (1), optic neuritis (1), increased spasticity (2), and worsening balance (2). Of the 8 neurological events, 5 were determined to be possibly related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Other Musculoskeletal Conditions', 'notes': 'Events included swelling, tendonitis, sprain, and spinal stenosis. Of the 8 events, 3 were determined to be possibly related, and 1 was determined to be related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'notes': 'Pain was reported at the ankle (1), back (14), chest (3), elbow (1), foot (2), hip (3), knee (10), leg (2), neck (2), pelvis (1), shoulder (5), and thigh (1). Of the 48 events, 18 were possibly related, and 5 were related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 22, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 26, 'numAffected': 24}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Symptoms post-COVID vaccine', 'notes': 'All were determined to be not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory infection', 'notes': 'All were determined to be not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'notes': 'All were determined to be not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vertigo', 'notes': 'All were determined to be not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weakness', 'notes': 'Of the 6 reports of weakness, 5 were determined to be possibly related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Coronavirus infections', 'notes': 'This SAE was determined to be not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elective hip arthroplasty', 'notes': 'This SAE was determined to be not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall resulting in fracture', 'notes': 'This SAE was determined to be not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Herniated disc', 'notes': 'This SAE was determined to be not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Increase in multiple sclerosis (MS) symptoms', 'notes': 'Participant missed an infusion of their disease-modifying therapy (DMT) which led to a severe increase in MS symptoms and hospitalization. This SAE was determined to be not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Septic shock of unknown etiology', 'notes': 'This SAE was determined to be not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Viral infection', 'notes': 'This SAE was determined to be not related to the study intervention.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 181, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Timed 25 Foot Walk Test (T25FWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Facility-based Rehabilitation', 'description': 'Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}, {'id': 'OG001', 'title': 'Telerehabilitation', 'description': 'Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}], 'classes': [{'title': 'Walking speed at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.88', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '2.62', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'Walking speed at 16 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.41', 'spread': '1.12', 'groupId': 'OG000'}, {'value': '3.26', 'spread': '1.08', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.14', 'ciUpperLimit': '0.44', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.10', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'We chose a non-inferiority margin of 10% (or 0.10 feet per second) for this population.'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline T25FWT at 16-weeks', 'description': 'The Timed 25 Foot Walk Test (T25FWT) is a measure of walking speed. Individuals are instructed to walk 25 feet as quickly and safely as possible from one marked end to the other.\n\nHigher walking speed (feet per second) indicate improved walking function.', 'unitOfMeasure': 'feet per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups.'}, {'type': 'SECONDARY', 'title': 'Six Minute Walk Test (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Facility-based Rehabilitation', 'description': 'Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}, {'id': 'OG001', 'title': 'Telerehabilitation', 'description': 'Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}], 'classes': [{'title': 'Walking distance at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '963.3', 'spread': '381.1', 'groupId': 'OG000'}, {'value': '884.2', 'spread': '392.3', 'groupId': 'OG001'}]}]}, {'title': 'Walking distance at 16 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1099.6', 'spread': '395.1', 'groupId': 'OG000'}, {'value': '1027.1', 'spread': '367.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '72.46', 'ciLowerLimit': '-29.56', 'ciUpperLimit': '174.5', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '384.1', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at 16 weeks', 'description': 'The six minute walk test (6MWT) assesses walking endurance and aerobic capacity. The score is the distance walked in 6 minutes. Higher scores (more distance walked in feet) indicate improved walking capacity.', 'unitOfMeasure': 'feet', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups.'}, {'type': 'SECONDARY', 'title': 'Multiple Sclerosis Walking Scale (MSWS)-12 Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Facility-based Rehabilitation', 'description': 'Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}, {'id': 'OG001', 'title': 'Telerehabilitation', 'description': 'Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}], 'classes': [{'title': 'MSWS at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '197', 'groupId': 'OG000'}, {'value': '179', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '61.36', 'spread': '21.81', 'groupId': 'OG000'}, {'value': '62.45', 'spread': '22.35', 'groupId': 'OG001'}]}]}, {'title': 'MSWS at 16 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.54', 'spread': '24.83', 'groupId': 'OG000'}, {'value': '58.25', 'spread': '25.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.13', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.71', 'ciLowerLimit': '-10.84', 'ciUpperLimit': '1.41', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '24.96', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at 16 weeks', 'description': 'The MSWS-12 is a self-reported measure of the impact of multiple sclerosis (MS) on walking ability and daily activities over the past two weeks. Items are scored from 1-5, with 1 meaning no limitation and 5 meaning extreme limitation.\n\nScores are calculated by first adding the responses, and getting a total score of 12 - 60. This score is then transformed to a 0 - 100 scale (Nilsagard et al, 2007) by subtracting 12 from the sum, dividing by 48, and then multiplying by 100.\n\nHigher scores indicate a greater impact of MS on walking than lower scores.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups.'}, {'type': 'SECONDARY', 'title': 'Godin Leisure-Time Physical Activity (LTPA) Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Facility-based Rehabilitation', 'description': 'Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}, {'id': 'OG001', 'title': 'Telerehabilitation', 'description': 'Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}], 'classes': [{'title': 'LTPA at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.48', 'spread': '8.15', 'groupId': 'OG000'}, {'value': '7.56', 'spread': '8.01', 'groupId': 'OG001'}]}]}, {'title': 'LTPA at 16 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.09', 'spread': '17.70', 'groupId': 'OG000'}, {'value': '22.21', 'spread': '18.88', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.70', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.88', 'ciLowerLimit': '-3.55', 'ciUpperLimit': '5.32', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '18.22', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at 16 weeks', 'description': 'The Godin LTPA is a 4-item, self-administered questionnaire assessing leisure-time physical activity. 3 questions ask how many times the individual participated in mild/light (e.g. yoga, easy walking), moderate (e.g. tennis, fast walking), and/or strenuous (e.g. running, basketball) activities in the past 7 days. The 4th question asks how often in a typical 7-day period the individual participates in an activity long enough to break a sweat (often, sometimes, or never/rarely).\n\nMore strenuous activities are more heavily weighted. Total leisure activity score is calculated by multiplying the number of strenuous activities by 9, the number of moderate activities by 5, and the number of mild activities by 3, and then adding those scores together.\n\nA higher score means that the individual participates in more and/or more vigorous leisure-time physical activity. 24 units or more = active; 14-23 units = moderately active; \\< 14 units = sedentary.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups.'}, {'type': 'SECONDARY', 'title': 'Quality of Life in Neurological Disorders (Neuro-QOL) Survey', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Facility-based Rehabilitation', 'description': 'Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}, {'id': 'OG001', 'title': 'Telerehabilitation', 'description': 'Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}], 'classes': [{'title': 'Baseline Anxiety Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.88', 'spread': '7.01', 'groupId': 'OG000'}, {'value': '17.19', 'spread': '7.28', 'groupId': 'OG001'}]}]}, {'title': '16 week Anxiety Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.41', 'spread': '6.86', 'groupId': 'OG000'}, {'value': '14.75', 'spread': '6.50', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Depression Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.58', 'spread': '6.14', 'groupId': 'OG000'}, {'value': '13.90', 'spread': '6.58', 'groupId': 'OG001'}]}]}, {'title': '16 week Depression Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.56', 'spread': '6.20', 'groupId': 'OG000'}, {'value': '12.31', 'spread': '6.10', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Fatigue Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '23.74', 'spread': '7.58', 'groupId': 'OG000'}, {'value': '24.96', 'spread': '7.17', 'groupId': 'OG001'}]}]}, {'title': '16 week Fatigue Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.44', 'spread': '7.85', 'groupId': 'OG000'}, {'value': '22.31', 'spread': '7.12', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Upper Extremity Function Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.71', 'spread': '4.09', 'groupId': 'OG000'}, {'value': '36.78', 'spread': '4.09', 'groupId': 'OG001'}]}]}, {'title': '16 week Upper Extremity Function Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '37.12', 'spread': '4.08', 'groupId': 'OG000'}, {'value': '37.06', 'spread': '3.49', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Lower Extremity Function Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.53', 'spread': '5.26', 'groupId': 'OG000'}, {'value': '30.17', 'spread': '5.21', 'groupId': 'OG001'}]}]}, {'title': '16 week Lower Extremity Function Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.04', 'spread': '5.22', 'groupId': 'OG000'}, {'value': '31.52', 'spread': '5.72', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Cognitive Function Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.46', 'spread': '7.55', 'groupId': 'OG000'}, {'value': '30.41', 'spread': '7.09', 'groupId': 'OG001'}]}]}, {'title': '16 week Cognitive Function Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.35', 'spread': '7.52', 'groupId': 'OG000'}, {'value': '32.24', 'spread': '6.14', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Emotional and Behavioral Dyscontrol Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.85', 'spread': '5.84', 'groupId': 'OG000'}, {'value': '14.66', 'spread': '5.65', 'groupId': 'OG001'}]}]}, {'title': '16 week Emotional and Behavioral Dyscontrol Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.27', 'spread': '6.14', 'groupId': 'OG000'}, {'value': '13.19', 'spread': '4.92', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Positive Affect and Well-Being Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.20', 'spread': '7.44', 'groupId': 'OG000'}, {'value': '34.65', 'spread': '7.14', 'groupId': 'OG001'}]}]}, {'title': '16 week Positive Affect and Well-Being Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.55', 'spread': '7.21', 'groupId': 'OG000'}, {'value': '36.01', 'spread': '7.03', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Sleep Distrubance Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.29', 'spread': '5.50', 'groupId': 'OG000'}, {'value': '19.33', 'spread': '6.11', 'groupId': 'OG001'}]}]}, {'title': '16 week Sleep Distrubance Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.76', 'spread': '5.88', 'groupId': 'OG000'}, {'value': '17.35', 'spread': '5.61', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Ability to Participate in Social Roles and Activities Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29.44', 'spread': '6.51', 'groupId': 'OG000'}, {'value': '28.60', 'spread': '7.04', 'groupId': 'OG001'}]}]}, {'title': '16 week Ability to Participate in Social Roles and Activities Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.77', 'spread': '6.78', 'groupId': 'OG000'}, {'value': '30.37', 'spread': '6.48', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Satisfaction with Social Roles and Activities Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.69', 'spread': '7.85', 'groupId': 'OG000'}, {'value': '24.57', 'spread': '7.37', 'groupId': 'OG001'}]}]}, {'title': '16 week Satisfaction with Social Roles and Activities Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '28.02', 'spread': '7.60', 'groupId': 'OG000'}, {'value': '27.37', 'spread': '7.23', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Stigma Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.28', 'spread': '6.34', 'groupId': 'OG000'}, {'value': '15.31', 'spread': '5.75', 'groupId': 'OG001'}]}]}, {'title': '16 week Stigma Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.74', 'spread': '5.94', 'groupId': 'OG000'}, {'value': '13.68', 'spread': '5.31', 'groupId': 'OG001'}]}]}, {'title': 'Baseline Communication Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.88', 'spread': '3.91', 'groupId': 'OG000'}, {'value': '21.76', 'spread': '3.89', 'groupId': 'OG001'}]}]}, {'title': '16 week Communication Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.07', 'spread': '3.58', 'groupId': 'OG000'}, {'value': '22.54', 'spread': '3.26', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.43', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.66', 'ciLowerLimit': '-0.97', 'ciUpperLimit': '2.30', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6.71', 'groupDescription': 'NeuroQOL Anxiety Domain', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.75', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.24', 'ciLowerLimit': '-1.26', 'ciUpperLimit': '1.74', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6.16', 'groupDescription': 'NeuroQOL Depression Domain', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.87', 'ciLowerLimit': '-2.71', 'ciUpperLimit': '0.97', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '7.54', 'groupDescription': 'NeuroQOL Fatigue Domain', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.91', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.06', 'ciLowerLimit': '-0.88', 'ciUpperLimit': '0.99', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.83', 'groupDescription': 'NeuroQOL Upper Extremity Function Domain', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.52', 'ciLowerLimit': '0.20', 'ciUpperLimit': '2.85', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.44', 'groupDescription': 'NeuroQOL Lower Extremity Function Domain', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.29', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.89', 'ciLowerLimit': '-2.54', 'ciUpperLimit': '0.76', 'groupDescription': 'NeuroQOL Cognitive Function Domain', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.08', 'ciLowerLimit': '-0.26', 'ciUpperLimit': '2.42', 'groupDescription': 'NeuroQOL Emotional and Behavioral Dyscontrol Domain', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.54', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.55', 'ciLowerLimit': '-1.19', 'ciUpperLimit': '2.28', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '7.13', 'groupDescription': 'NeuroQOL Positive Affect and Well-Being Domain', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.41', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.59', 'ciLowerLimit': '-2.00', 'ciUpperLimit': '0.81', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.76', 'groupDescription': 'NeuroQOL Sleep Disturbance Domain', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.63', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.40', 'ciLowerLimit': '-1.22', 'ciUpperLimit': '2.02', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6.65', 'groupDescription': 'NeuroQOL Ability to Participate in Social Roles and Activities Domain', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.48', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.65', 'ciLowerLimit': '-1.16', 'ciUpperLimit': '2.47', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '7.44', 'groupDescription': 'NeuroQOL Satisfaction with Social Roles and Activities Domain', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.92', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.07', 'ciLowerLimit': '-1.32', 'ciUpperLimit': '1.45', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.68', 'groupDescription': 'NeuroQOL Stigma Domain', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.28', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.47', 'ciLowerLimit': '-1.31', 'ciUpperLimit': '0.37', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '3.45', 'groupDescription': 'NeuroQOL Communication Domain', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at 16 weeks.', 'description': 'Domains (anxiety, depression, fatigue, upper extremity function, lower extremity function, cognitive function, emotional and behavioral dyscontrol, sleep disturbance, ability to participate in social roles and activities, satisfaction with social roles and activities, stigma) - possible score of 8-40. Positive affect domain has possible score of 9-45. Communication domain has possible score of 5-25. No clinical thresholds established. Higher scores indicate WORSE self-reported health for Anxiety, Depression, Fatigue, Emotional and Behavioral Dyscontrol, Sleep Disturbance, Stigma. Higher scores indicate BETTER self-reported health for Upper Extremity Function, Lower Extremity Function, Cognitive Function, Positive Affect \\& Well-Being, Ability to Participate in Social Roles and Activities, Satisfaction with Social Roles \\& Activities, Communication.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups.'}, {'type': 'SECONDARY', 'title': 'Multiple Sclerosis Impact Scale (MSIS)-29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Facility-based Rehabilitation', 'description': 'Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}, {'id': 'OG001', 'title': 'Telerehabilitation', 'description': 'Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}], 'classes': [{'title': 'Baseline MSIS-29 Physical Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.63', 'spread': '19.62', 'groupId': 'OG000'}, {'value': '41.59', 'spread': '18.24', 'groupId': 'OG001'}]}]}, {'title': '16 week MSIS-29 Physical Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.18', 'spread': '21.36', 'groupId': 'OG000'}, {'value': '34.65', 'spread': '19.61', 'groupId': 'OG001'}]}]}, {'title': 'Baseline MSIS-29 Psychological Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.71', 'spread': '21.33', 'groupId': 'OG000'}, {'value': '33.01', 'spread': '22.16', 'groupId': 'OG001'}]}]}, {'title': '16 week MSIS-29 Psychological Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.79', 'spread': '22.29', 'groupId': 'OG000'}, {'value': '26.17', 'spread': '20.06', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.34', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.48', 'ciLowerLimit': '-7.55', 'ciUpperLimit': '2.60', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '20.63', 'groupDescription': 'MSIS Physical', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.24', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.38', 'ciLowerLimit': '-6.63', 'ciUpperLimit': '3.88', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '21.37', 'groupDescription': 'MSIS Psychological', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at 16 weeks.', 'description': "The MSIS measures individual's views on the impact of MS on day-to-day life during the past two weeks. It is comprised of two subscales: a 20-item physical impact scale and a 9-item psychological impact scale. The MSIS has no combined total score. Scores on the physical impact scale can range from 20 to 80 and on the psychological impact scale from 9 to 36.\n\nLower scores indicate little impact of MS, and higher scores indicate a higher impact of MS (on either physical or psychological functioning).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups.'}, {'type': 'SECONDARY', 'title': 'Modified Fatigue Impact Scale (MFIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Facility-based Rehabilitation', 'description': 'Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}, {'id': 'OG001', 'title': 'Telerehabilitation', 'description': 'Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}], 'classes': [{'title': 'MFIS Cognitive at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.54', 'spread': '9.58', 'groupId': 'OG000'}, {'value': '14.96', 'spread': '9.06', 'groupId': 'OG001'}]}]}, {'title': 'MFIS Cognitive at 16 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.00', 'spread': '9.30', 'groupId': 'OG000'}, {'value': '11.63', 'spread': '8.36', 'groupId': 'OG001'}]}]}, {'title': 'MFIS Physical at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.02', 'spread': '7.81', 'groupId': 'OG000'}, {'value': '20.98', 'spread': '7.40', 'groupId': 'OG001'}]}]}, {'title': 'MFIS Physical at 16 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.57', 'spread': '8.21', 'groupId': 'OG000'}, {'value': '17.67', 'spread': '7.77', 'groupId': 'OG001'}]}]}, {'title': 'MFIS Psychosocial at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.89', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '3.97', 'spread': '2.20', 'groupId': 'OG001'}]}]}, {'title': 'MFIS Psychosocial at 16 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.93', 'spread': '2.20', 'groupId': 'OG000'}, {'value': '3.07', 'spread': '2.14', 'groupId': 'OG001'}]}]}, {'title': 'MFIS Total at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '38.45', 'spread': '17.36', 'groupId': 'OG000'}, {'value': '39.91', 'spread': '16.50', 'groupId': 'OG001'}]}]}, {'title': 'MFIS Total at 16 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '30.50', 'spread': '18.02', 'groupId': 'OG000'}, {'value': '32.37', 'spread': '15.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.74', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.37', 'ciLowerLimit': '-1.83', 'ciUpperLimit': '2.56', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '8.91', 'groupDescription': 'MFIS Cognitive', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.10', 'ciLowerLimit': '-4.07', 'ciUpperLimit': '-0.12', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '8.03', 'groupDescription': 'MFIS Physical', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.59', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.14', 'ciLowerLimit': '-0.68', 'ciUpperLimit': '0.39', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.17', 'groupDescription': 'MFIS Psychosocial', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.88', 'ciLowerLimit': '-6.05', 'ciUpperLimit': '2.30', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '17.00', 'groupDescription': 'MFIS Total', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at 16 weeks', 'description': "The MFIS is a 21-item questionnaire that measures the impact of fatigue on the participant's activities and lifestyle over the past four weeks. Items on the MFIS can be broken into three subscales (physical, cognitive, and psychosocial), as well as into a total MFIS score. The physical subscale score can range from 0 to 36. The cognitive subscale score can range from 0 to 40. The psychosocial subscale score can range from 0 to 8. The total MFIS score is the sum total of all three subscales, and can range from 0 to 84.\n\nHigher scores indicate a greater impact of fatigue on a person's activities.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups.'}, {'type': 'SECONDARY', 'title': 'Expanded Disability Status Scale (EDSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Facility-based Rehabilitation', 'description': 'Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}, {'id': 'OG001', 'title': 'Telerehabilitation', 'description': 'Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}], 'classes': [{'title': 'EDSS at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.32', 'spread': '0.95', 'groupId': 'OG000'}, {'value': '5.25', 'spread': '0.94', 'groupId': 'OG001'}]}]}, {'title': 'EDSS at 16 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.02', 'spread': '1.20', 'groupId': 'OG000'}, {'value': '5.04', 'spread': '1.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.87', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-.03', 'ciLowerLimit': '-0.34', 'ciUpperLimit': '0.29', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.18', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at 16 weeks', 'description': 'The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. It characterizes disability level and determines disability progression in people with MS. Higher scores reflect greater disability due to MS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups.'}, {'type': 'SECONDARY', 'title': 'Patient Determined Disease Steps (PDDS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Facility-based Rehabilitation', 'description': 'Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}, {'id': 'OG001', 'title': 'Telerehabilitation', 'description': 'Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}], 'classes': [{'title': 'PDDS at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.26', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '4.28', 'spread': '1.04', 'groupId': 'OG001'}]}]}, {'title': 'PDDS at 16 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.66', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '2.19', 'spread': '2.31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.54', 'ciLowerLimit': '-1.08', 'ciUpperLimit': '0.00', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.21', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline at 16 weeks', 'description': 'The PDDS is a patient-reported outcome of disability in MS. The scale focuses mainly on how well individuals with MS walk. Scores range from 0 (normal function) to 8 (bedridden). Higher scores reflect greater disability due to MS.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to the COVID pandemic, some participants were unable or unwilling to return for in-person assessments following the intervention. Additionally, we noted differential attrition rates and participation in outcome assessments across the two groups.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Facility-based Rehabilitation', 'description': 'Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}, {'id': 'FG001', 'title': 'Telerehabilitation', 'description': 'Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '198'}, {'groupId': 'FG001', 'numSubjects': '181'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '115'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '66'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '379', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Facility-based Rehabilitation', 'description': 'Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}, {'id': 'BG001', 'title': 'Telerehabilitation', 'description': 'Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions.\n\nExercise program for people with MS: The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '379', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '198', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '379', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'To qualify for this study, participants must have been aged 18 - 65.', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '379', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51.47', 'spread': '10.01', 'groupId': 'BG000'}, {'value': '50.08', 'spread': '9.18', 'groupId': 'BG001'}, {'value': '50.81', 'spread': '9.36', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'To qualify for this study, participants must have been aged 18 - 65.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}, {'value': '180', 'groupId': 'BG001'}, {'value': '378', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '142', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 value is missing in Gender.'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '379', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '185', 'groupId': 'BG000'}, {'value': '170', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '379', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '126', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '246', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'MS type', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '184', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '351', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Primary Progressive Multiple Sclerosis (PPMS)', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Progressive Relapsing Multiple Sclerosis (PRMS)', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Relapsing Remitting Multiple Sclerosis (RRMS)', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '255', 'groupId': 'BG002'}]}, {'title': 'Secondary Progressive Multiple Sclerosis (SPMS)', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '28 values are missing for MS type.'}, {'title': 'Employment Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '379', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Employed', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}, {'title': 'Unemployed', 'measurements': [{'value': '87', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '174', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Living Arrangement', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '377', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Living Alone', 'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'Living With Others', 'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '294', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '2 values are missing for Living Arrangement.'}, {'title': 'Patient-Determined Disease Steps (PDDS) Scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '379', 'groupId': 'BG002'}]}], 'categories': [{'title': '1 (Mild Disability)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': '3 (Gait Disability)', 'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}, {'title': '4 (Early Cane)', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}, {'title': '5 (Late Cane)', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': '6 (Bilateral Support)', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'The Patient-Determined Disease Steps (PDDS) scale is a patient-reported measure of disability due to multiple sclerosis (MS). The scale focuses mainly on how well individuals with MS walk. Scores range from 0 (normal function) to 8 (bedridden). Higher scores reflect greater disability due to MS.', 'unitOfMeasure': 'Participants'}, {'title': 'Insurance', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '379', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Direct purchase', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': 'Employer', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}, {'title': 'Medicare', 'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '111', 'groupId': 'BG002'}]}, {'title': 'Medicaid', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'No insurance', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Short Assessment of Health Literacy-English (SAHL-E)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '379', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17.51', 'spread': '1.19', 'groupId': 'BG000'}, {'value': '17.68', 'spread': '0.61', 'groupId': 'BG001'}, {'value': '17.59', 'spread': '0.96', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The SAHL-E is an 18-item assessment of an English-speaking adult's ability to read and understand common medical terms. To be considered correct, the item must be pronounced correctly and accurately associated with a related term.\n\nScores range from 0 (minimum) to 18 (maximum), with higher scores representing a greater ability to read and understand medical terms. A score between 0 and 14 suggests low health literacy.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mini Mental State Examination (MMSE)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'BG000'}, {'value': '181', 'groupId': 'BG001'}, {'value': '379', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29.33', 'spread': '1.16', 'groupId': 'BG000'}, {'value': '29.43', 'spread': '0.99', 'groupId': 'BG001'}, {'value': '29.38', 'spread': '1.08', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Mini Mental Status Examination (MMSE) is a screening tool for cognitive impairment. Scores on the MMSE range from 0 (minimum) to 30 (maximum).\n\nLower scores indicate greater cognitive impairment. Levels of impairment have been classified as (Tombaugh \\& McIntyre, 1992) as:\n\nNormal cognitive functioning: 24-30 Mild cognitive impairment: 18-24 Severe cognitive impairment: 0-17\n\nParticipants were excluded from the study if their MMSE score was \\< 19.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-17', 'size': 699226, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-11T10:07', 'hasProtocol': True}, {'date': '2023-02-23', 'size': 234085, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-07-11T10:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Evaluators who assess clinical reported outcomes will be blinded to arm assignment.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two-stage randomized choice design aimed at noninferiority.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 379}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-09', 'studyFirstSubmitDate': '2018-03-06', 'resultsFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2018-03-12', 'lastUpdatePostDateStruct': {'date': '2025-01-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-24', 'studyFirstPostDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timed 25 Foot Walk Test (T25FWT)', 'timeFrame': 'Change from baseline T25FWT at 16-weeks', 'description': 'The Timed 25 Foot Walk Test (T25FWT) is a measure of walking speed. Individuals are instructed to walk 25 feet as quickly and safely as possible from one marked end to the other.\n\nHigher walking speed (feet per second) indicate improved walking function.'}], 'secondaryOutcomes': [{'measure': 'Six Minute Walk Test (6MWT)', 'timeFrame': 'Change from baseline at 16 weeks', 'description': 'The six minute walk test (6MWT) assesses walking endurance and aerobic capacity. The score is the distance walked in 6 minutes. Higher scores (more distance walked in feet) indicate improved walking capacity.'}, {'measure': 'Multiple Sclerosis Walking Scale (MSWS)-12 Questionnaire', 'timeFrame': 'Change from baseline at 16 weeks', 'description': 'The MSWS-12 is a self-reported measure of the impact of multiple sclerosis (MS) on walking ability and daily activities over the past two weeks. Items are scored from 1-5, with 1 meaning no limitation and 5 meaning extreme limitation.\n\nScores are calculated by first adding the responses, and getting a total score of 12 - 60. This score is then transformed to a 0 - 100 scale (Nilsagard et al, 2007) by subtracting 12 from the sum, dividing by 48, and then multiplying by 100.\n\nHigher scores indicate a greater impact of MS on walking than lower scores.'}, {'measure': 'Godin Leisure-Time Physical Activity (LTPA) Questionnaire', 'timeFrame': 'Change from baseline at 16 weeks', 'description': 'The Godin LTPA is a 4-item, self-administered questionnaire assessing leisure-time physical activity. 3 questions ask how many times the individual participated in mild/light (e.g. yoga, easy walking), moderate (e.g. tennis, fast walking), and/or strenuous (e.g. running, basketball) activities in the past 7 days. The 4th question asks how often in a typical 7-day period the individual participates in an activity long enough to break a sweat (often, sometimes, or never/rarely).\n\nMore strenuous activities are more heavily weighted. Total leisure activity score is calculated by multiplying the number of strenuous activities by 9, the number of moderate activities by 5, and the number of mild activities by 3, and then adding those scores together.\n\nA higher score means that the individual participates in more and/or more vigorous leisure-time physical activity. 24 units or more = active; 14-23 units = moderately active; \\< 14 units = sedentary.'}, {'measure': 'Quality of Life in Neurological Disorders (Neuro-QOL) Survey', 'timeFrame': 'Change from baseline at 16 weeks.', 'description': 'Domains (anxiety, depression, fatigue, upper extremity function, lower extremity function, cognitive function, emotional and behavioral dyscontrol, sleep disturbance, ability to participate in social roles and activities, satisfaction with social roles and activities, stigma) - possible score of 8-40. Positive affect domain has possible score of 9-45. Communication domain has possible score of 5-25. No clinical thresholds established. Higher scores indicate WORSE self-reported health for Anxiety, Depression, Fatigue, Emotional and Behavioral Dyscontrol, Sleep Disturbance, Stigma. Higher scores indicate BETTER self-reported health for Upper Extremity Function, Lower Extremity Function, Cognitive Function, Positive Affect \\& Well-Being, Ability to Participate in Social Roles and Activities, Satisfaction with Social Roles \\& Activities, Communication.'}, {'measure': 'Multiple Sclerosis Impact Scale (MSIS)-29', 'timeFrame': 'Change from baseline at 16 weeks.', 'description': "The MSIS measures individual's views on the impact of MS on day-to-day life during the past two weeks. It is comprised of two subscales: a 20-item physical impact scale and a 9-item psychological impact scale. The MSIS has no combined total score. Scores on the physical impact scale can range from 20 to 80 and on the psychological impact scale from 9 to 36.\n\nLower scores indicate little impact of MS, and higher scores indicate a higher impact of MS (on either physical or psychological functioning)."}, {'measure': 'Modified Fatigue Impact Scale (MFIS)', 'timeFrame': 'Change from baseline at 16 weeks', 'description': "The MFIS is a 21-item questionnaire that measures the impact of fatigue on the participant's activities and lifestyle over the past four weeks. Items on the MFIS can be broken into three subscales (physical, cognitive, and psychosocial), as well as into a total MFIS score. The physical subscale score can range from 0 to 36. The cognitive subscale score can range from 0 to 40. The psychosocial subscale score can range from 0 to 8. The total MFIS score is the sum total of all three subscales, and can range from 0 to 84.\n\nHigher scores indicate a greater impact of fatigue on a person's activities."}, {'measure': 'Expanded Disability Status Scale (EDSS)', 'timeFrame': 'Change from baseline at 16 weeks', 'description': 'The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments. It characterizes disability level and determines disability progression in people with MS. Higher scores reflect greater disability due to MS.'}, {'measure': 'Patient Determined Disease Steps (PDDS)', 'timeFrame': 'Change from baseline at 16 weeks', 'description': 'The PDDS is a patient-reported outcome of disability in MS. The scale focuses mainly on how well individuals with MS walk. Scores range from 0 (normal function) to 8 (bedridden). Higher scores reflect greater disability due to MS.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple sclerosis', 'Exercise', 'Physical activity', 'Telerehabilitation', 'Comparative effectiveness study', 'Social cognitive theory', 'Health behavior change'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '31022481', 'type': 'BACKGROUND', 'citation': 'Motl RW, Backus D, Neal WN, Cutter G, Palmer L, McBurney R, Schmidt H, Bethoux F, Hebert J, Ng A, McCully KK, Plummer P. Rationale and design of the STEP for MS Trial: Comparative effectiveness of Supervised versus Telerehabilitation Exercise Programs for Multiple Sclerosis. Contemp Clin Trials. 2019 Jun;81:110-122. doi: 10.1016/j.cct.2019.04.013. Epub 2019 Apr 22.'}, {'pmid': '37633458', 'type': 'BACKGROUND', 'citation': 'Neal WN, Moldavskiy M, Truax B, Ithurburn A, Ware M, Hebert JR, Opielinski L, Penko AL, Kern K, Palmer L, Backus D, Motl RW. Intervention fidelity and adaptation in a multi-site exercise training intervention for adults with multiple sclerosis. Contemp Clin Trials. 2023 Oct;133:107320. doi: 10.1016/j.cct.2023.107320. Epub 2023 Aug 24.'}, {'pmid': '36269870', 'type': 'BACKGROUND', 'citation': 'Palmer LC, Neal WN, Motl RW, Backus D. The Impact of COVID-19 Lockdown Restrictions on Exercise Behavior Among People With Multiple Sclerosis Enrolled in an Exercise Trial: Qualitative Interview Study. JMIR Rehabil Assist Technol. 2022 Nov 22;9(4):e42157. doi: 10.2196/42157.'}, {'pmid': '38889558', 'type': 'BACKGROUND', 'citation': 'Motl RW, Plummer P, Backus D, Hebert JR, Neal WN, Ng A, Lowman J, Bethoux F, Schmidt H, McBurney R, McCully KK, Cutter G. Validation of scores from a telephone administered multiple sclerosis walking scale-12 in persons with multiple sclerosis. Mult Scler Relat Disord. 2024 Aug;88:105715. doi: 10.1016/j.msard.2024.105715. Epub 2024 Jun 9.'}, {'pmid': '39986137', 'type': 'DERIVED', 'citation': 'Motl RW, Backus D, Hebert JR, Ng AV, McCully KK, Neal WN, Schmidt H, McBurney R, Plummer P, Bethoux F, Lowman J, Cutter G. Walking performance is worse in black than white people with multiple sclerosis. Mult Scler Relat Disord. 2025 Mar;95:106343. doi: 10.1016/j.msard.2025.106343. Epub 2025 Feb 18.'}, {'pmid': '39390466', 'type': 'DERIVED', 'citation': 'Motl R, Neal W, Backus D, Hebert J, McCully K, Bethoux F, Plummer P, Ng A, Lowman J, Schmidt H, McBurney R, Cutter G. Middle-range scores from the patient determined disease steps scale reflect varying levels of walking dysfunction in multiple sclerosis. BMC Neurol. 2024 Oct 10;24(1):383. doi: 10.1186/s12883-024-03871-1.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effectiveness of an exercise program delivered in a conventional facility-based format versus a telerehabilitation format, which takes place in the home. Exercise can improve mobility and perhaps decrease the rate and extent of disability in people with MS. Evidence shows that traditional, facility-based exercise training may help people with MS consistently participate in exercise or to exercise at a higher, more intense level. Despite this evidence, lack of access to facility-based exercise programs may make it difficult for people with MS to engage in exercise.Telerehabilitation (telerehab) has great potential to overcome challenges associated with facility-based programs. Telerehab can include videoconferencing, remote monitoring of signs and activity, and dissemination of specialized and individualized information via electronic mechanisms, such as smartphones and computers. Both facility-based and telerehab exercise training have yielded positive results in people with MS, but have not been compared head-to-head. The current study will fill this gap in the evidence base and compare the outcomes of delivering the same exercise interventions in a facility or in the home/community using a telerehab approach. The interventions are designed to be identical in content, with the only difference being the mode of training delivery.', 'detailedDescription': "Funded by Patient-Centered Outcomes Research Institute (PCORI), this four-year, multi-site study aims to compare the effectiveness of a 16-week telerehabilitation (telerehab) exercise program and a facility-based exercise program on Multiple Sclerosis (MS) outcomes. The research study design is a two-stage randomized choice design aimed at non-inferiority.\n\nFour hundred participants with MS who have ambulatory difficulties will be recruited from nine sites. First level randomization will assign participants to one of two groups - Choice or Random. The participants in Choice will be able to choose in which program they wish to participate (telerehab or facility-based). Individuals in the Random group, will be further randomized to either the telerehab or facility-based program. The research protocol and associated tools will be reviewed and approved by all relevant Research Review Committees before any research takes place. The study will comply with best practices in human subjects' research including following HIPAA guidelines and using strict informed consent procedures. Clinical reported outcome measures and patient reported outcome measures will be administered at baseline, immediately post-intervention (at 16 weeks), and at 12 months post-intervention. Patient reported outcomes will also be administered at 2 months and 6 months after the start of the intervention.\n\nDr. Deborah Backus is the principal investigator (PI) and Prof. Robert Motl is the co-Principal Investigator supported by collaborating co-Investigators at the Cleveland Clinic Mellen Center, Ohio; Marquette University, Wisconsin; University of Colorado, Denver; University of North Carolina, Chapel Hill; the University of Georgia; the Tanner Center for Multiple Sclerosis, Birmingham Alabama; Massachusetts General Hospital, Boston, Massachusetts; and the iConquerMS outcomes data collaborative (Accelerated Cure Project for MS). Shepherd Center is the primary and coordinating site for all study activities under Dr. Backus. University of Alabama at Birmingham (UAB) under the leadership of Prof. Motl will oversee delivery of the training programs, and statistical analysis under the direction of Dr. Gary Cutter.\n\nThis study will yield important data regarding the comparative impact of exercise programs on MS outcomes and provide information to people with MS, health providers, payers, exercise partners, and policy makers about how people with MS who have ambulatory difficulties can safely and effectively exercise."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mild to moderate MS\n* Has limitations in walking but can walk 25 feet\n* Does not participate in a rigorous exercise program\n* Can travel to trial site for assessments and training\n\nExclusion Criteria:\n\n* Relapse in the past 30 days\n* Other neurological or musculoskeletal disorders'}, 'identificationModule': {'nctId': 'NCT03468868', 'briefTitle': 'Comparative Effectiveness Study Telerehab Versus Conventional', 'organization': {'class': 'OTHER', 'fullName': 'Shepherd Center, Atlanta GA'}, 'officialTitle': 'Comparative Effectiveness Study of an Exercise Intervention Delivered Via Telerehabilitation and Conventional Mode of Delivery', 'orgStudyIdInfo': {'id': 'MS-1610-36999'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Facility-based rehabilitation', 'description': 'Participants will conduct the exercise program for people with MS in a facility, for example a gym, or rehabilitation center. They will receive coaching on site at the facility.', 'interventionNames': ['Behavioral: Exercise program for people with MS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Telerehabilitation', 'description': 'Participants will conduct the exercise program for people with MS at home and receive coaching via phone or Skype sessions.', 'interventionNames': ['Behavioral: Exercise program for people with MS']}], 'interventions': [{'name': 'Exercise program for people with MS', 'type': 'BEHAVIORAL', 'description': 'The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.', 'armGroupLabels': ['Facility-based rehabilitation', 'Telerehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The Tanner Center for Multiple Sclerosis', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '80045', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '30602', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'University of Georgia', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Shepherd Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '27599', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '53233', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marquette University', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Deborah Backus, PT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shepherd Center, Atlanta GA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shepherd Center, Atlanta GA', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, {'name': 'University of Georgia', 'class': 'OTHER'}, {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, {'name': 'Marquette University', 'class': 'OTHER'}, {'name': 'Accelerated Cure Project for Multiple Sclerosis', 'class': 'OTHER'}, {'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}, {'name': 'Tanner Foundation for Multiple Sclerosis', 'class': 'OTHER'}, {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Multiple Sclerosis Research', 'investigatorFullName': 'Deborah Backus', 'investigatorAffiliation': 'Shepherd Center, Atlanta GA'}}}}