Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-10 @ 2:11 PM
Study NCT ID:
NCT03256851
Status:
COMPLETED
Last Update Posted:
2019-10-30
First Post:
2017-08-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Telephone-Delivered Exercise for Multiple Sclerosis Fatigue
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D005221', 'term': 'Fatigue'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nora.fritz@wayne.edu', 'phone': '(313) 577-1096', 'title': 'Dr. Nora Fritz', 'organization': 'Wayne State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '8 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'In-Person Delivered Exercise', 'description': 'Participants in the in-person training group will:\n\n1. participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.\n2. complete one of their prescribed training sessions (lasting 1 hour total) each week with a physical therapist or trained member of the research team. Training sessions will focus on progression of aerobic and strength training exercises.\n\nIn-Person Delivered Exercise Therapy: A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.\n\nAerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.\n\nStrength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Telephone-Delivered Exercise', 'description': 'Participants in the telephone-delivered training group will:\n\n1. participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.\n2. receive a 60-minute, 1x/week telephone call from a trained research team member. Participants will report progress from the prior week, troubleshoot any issues, and receive progressions of both aerobic and strength exercises for the upcoming week.\n\nTelephone-Delivered Exercise Therapy: A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.\n\nAerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.\n\nStrength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Daily Average Fatigue Intensity Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'In-Person Delivered Exercise', 'description': 'Participants in the in-person training group will:\n\n1. participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.\n2. complete one of their prescribed training sessions (lasting 1 hour total) each week with a physical therapist or trained member of the research team. Training sessions will focus on progression of aerobic and strength training exercises.\n\nIn-Person Delivered Exercise Therapy: A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.\n\nAerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.\n\nStrength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week.'}, {'id': 'OG001', 'title': 'Telephone-Delivered Exercise', 'description': 'Participants in the telephone-delivered training group will:\n\n1. participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.\n2. receive a 60-minute, 1x/week telephone call from a trained research team member. Participants will report progress from the prior week, troubleshoot any issues, and receive progressions of both aerobic and strength exercises for the upcoming week.\n\nTelephone-Delivered Exercise Therapy: A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.\n\nAerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.\n\nStrength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '3.9', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre) and 8 weeks (post)', 'description': 'Rated on a 0-10 numerical rating scale, entered directly on the PRO-Diary (CamNTech, Cambridge, UK), which provides a more reliable and sensitive assay of symptoms compared to traditional recall measures.\n\nA score of 0 indicates no fatigue and a score of 10 indicates extremely severe fatigue.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Daily Average Fatigue Interference Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'In-Person Delivered Exercise', 'description': 'Participants in the in-person training group will:\n\n1. participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.\n2. complete one of their prescribed training sessions (lasting 1 hour total) each week with a physical therapist or trained member of the research team. Training sessions will focus on progression of aerobic and strength training exercises.\n\nIn-Person Delivered Exercise Therapy: A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.\n\nAerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.\n\nStrength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week.'}, {'id': 'OG001', 'title': 'Telephone-Delivered Exercise', 'description': 'Participants in the telephone-delivered training group will:\n\n1. participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.\n2. receive a 60-minute, 1x/week telephone call from a trained research team member. Participants will report progress from the prior week, troubleshoot any issues, and receive progressions of both aerobic and strength exercises for the upcoming week.\n\nTelephone-Delivered Exercise Therapy: A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.\n\nAerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.\n\nStrength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week.'}], 'classes': [{'title': 'Pre', 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '3.0', 'spread': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Post', 'categories': [{'measurements': [{'value': '2.7', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (pre) and 8 weeks (post)', 'description': "Rated on a 0-10 numerical rating scale, entered directly on the PRO-Diary (CamNTech, Cambridge, UK), which provides a more reliable and sensitive assay of symptoms compared to traditional recall measures.' A score of 0 indicates no interference while a score of 10 indicates complete interference (i.e., worse).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'In-Person Delivered Exercise', 'description': 'Participants in the in-person training group will:\n\n1. participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.\n2. complete one of their prescribed training sessions (lasting 1 hour total) each week with a physical therapist or trained member of the research team. Training sessions will focus on progression of aerobic and strength training exercises.\n\nIn-Person Delivered Exercise Therapy: A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.\n\nAerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.\n\nStrength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week.'}, {'id': 'FG001', 'title': 'Telephone-Delivered Exercise', 'description': 'Participants in the telephone-delivered training group will:\n\n1. participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.\n2. receive a 60-minute, 1x/week telephone call from a trained research team member. Participants will report progress from the prior week, troubleshoot any issues, and receive progressions of both aerobic and strength exercises for the upcoming week.\n\nTelephone-Delivered Exercise Therapy: A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.\n\nAerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.\n\nStrength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'In-Person Delivered Exercise', 'description': 'Participants in the in-person training group will:\n\n1. participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.\n2. complete one of their prescribed training sessions (lasting 1 hour total) each week with a physical therapist or trained member of the research team. Training sessions will focus on progression of aerobic and strength training exercises.\n\nIn-Person Delivered Exercise Therapy: A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.\n\nAerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.\n\nStrength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week.'}, {'id': 'BG001', 'title': 'Telephone-Delivered Exercise', 'description': 'Participants in the telephone-delivered training group will:\n\n1. participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.\n2. receive a 60-minute, 1x/week telephone call from a trained research team member. Participants will report progress from the prior week, troubleshoot any issues, and receive progressions of both aerobic and strength exercises for the upcoming week.\n\nTelephone-Delivered Exercise Therapy: A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.\n\nAerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.\n\nStrength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', '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': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '50.7', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '45.9', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '48.3', 'spread': '7.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Fatigue Severity Scale', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51.1', 'spread': '4.1', 'groupId': 'BG000'}, {'value': '47.8', 'spread': '9.5', 'groupId': 'BG001'}, {'value': '48.5', 'spread': '7.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'The Fatigue Severity Scale is a 9-item questionnaire in which participants rate their fatigue from 1-7 for each question. A higher score (max total = 63) indicates worse fatigue.\n\nThe total score is reported. The range of possible scores is 9-63.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Patient Determined Disease Steps (PDDS)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'BG000', 'lowerLimit': '3', 'upperLimit': '5'}, {'value': '2', 'groupId': 'BG001', 'lowerLimit': '1', 'upperLimit': '3'}, {'value': '3', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'description': "The PDDS requires a single response on a 0-8 scale that indicates the person's perceived level of disability from 0 (normal - I have some mild symptoms, mostly sensory due to MS but they do not limit my activity) to 8 (bedridden- unable to sit in a wheelchair for more than one hour).\n\nThe total score is reported, with higher numbers indicating worse disability.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29.1', 'groupId': 'BG000', 'lowerLimit': '27.1', 'upperLimit': '34.7'}, {'value': '33.8', 'groupId': 'BG001', 'lowerLimit': '30.8', 'upperLimit': '38.7'}, {'value': '32.9', 'groupId': 'BG002', 'lowerLimit': '27.8', 'upperLimit': '36.4'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Years Since Diagnosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'BG000', 'lowerLimit': '4', 'upperLimit': '9'}, {'value': '13.5', 'groupId': 'BG001', 'lowerLimit': '5', 'upperLimit': '16'}, {'value': '8', 'groupId': 'BG002', 'lowerLimit': '4', 'upperLimit': '13.5'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-08', 'size': 344413, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-10-07T10:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-07', 'studyFirstSubmitDate': '2017-08-16', 'resultsFirstSubmitDate': '2019-09-11', 'studyFirstSubmitQcDate': '2017-08-17', 'lastUpdatePostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-10-07', 'studyFirstPostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Daily Average Fatigue Intensity Score', 'timeFrame': 'Baseline (pre) and 8 weeks (post)', 'description': 'Rated on a 0-10 numerical rating scale, entered directly on the PRO-Diary (CamNTech, Cambridge, UK), which provides a more reliable and sensitive assay of symptoms compared to traditional recall measures.\n\nA score of 0 indicates no fatigue and a score of 10 indicates extremely severe fatigue.'}, {'measure': 'Daily Average Fatigue Interference Score', 'timeFrame': 'Baseline (pre) and 8 weeks (post)', 'description': "Rated on a 0-10 numerical rating scale, entered directly on the PRO-Diary (CamNTech, Cambridge, UK), which provides a more reliable and sensitive assay of symptoms compared to traditional recall measures.' A score of 0 indicates no interference while a score of 10 indicates complete interference (i.e., worse)."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis', 'Fatigue', 'Physical Activity']}, 'referencesModule': {'references': [{'pmid': '31738192', 'type': 'DERIVED', 'citation': 'Kratz AL, Atalla M, Whibley D, Myles A, Thurston T, Fritz NE. Calling Out MS Fatigue: Feasibility and Preliminary Effects of a Pilot Randomized Telephone-Delivered Exercise Intervention for Multiple Sclerosis Fatigue. J Neurol Phys Ther. 2020 Jan;44(1):23-31. doi: 10.1097/NPT.0000000000000296.'}]}, 'descriptionModule': {'briefSummary': 'Multiple sclerosis (MS) is a progressive demyelinating disorder that damages white matter in the central nervous system. Although individuals experience mobility (e.g., walking, balance) impairments that lower quality of life and limit participation in daily activities, one of the most prominent symptoms is fatigue. Up to 92% of individuals report fatigue that manifests as lack of energy, exhaustion or worsening of MS symptoms and ultimately contributes to increasing disability. The currently available pharmaceutical treatments fail to fully control fatigue in the majority of individuals with MS; non-pharmacologic therapies such as exercise and behavioral therapies offer the best hope for combating MS fatigue in the majority of individuals.\n\nExercise therapy is effective in reducing MS fatigue. However, access to exercise therapy is seriously limited for many individuals with MS due to geographical location, limited resources (e.g., financial, transportation), and/or disability. Thus, the development and evaluation of an alternative delivery method for exercise therapy to target MS-related fatigue that increases participation and reduces barriers is critical.\n\nIn this study, the investigators will compare traditional in-person delivered exercise therapy to telephone-delivered exercise therapy to target fatigue in persons with MS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of RRMS, SPMS, or PPMS\n* Ambulatory for at least 5 minutes at a time\n* Self-reported fatigue on Fatigue Severity Scale\n* Able to follow study-related commands\n* Able to attend study appointments\n\nExclusion Criteria:\n\n* MS exacerbation within the past 30 days\n* Evidence of another neurological disorder or orthopedic disorder that would interfere with exercise participation\n* Acute illness or injury that prevents participation in the intervention\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT03256851', 'briefTitle': 'Telephone-Delivered Exercise for Multiple Sclerosis Fatigue', 'organization': {'class': 'OTHER', 'fullName': 'Wayne State University'}, 'officialTitle': 'Telephone-Delivered Interventions to Target Multiple Sclerosis Fatigue', 'orgStudyIdInfo': {'id': '1612000180'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'In-Person Delivered Exercise', 'description': 'Participants in the in-person training group will:\n\n1. participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.\n2. complete one of their prescribed training sessions (lasting 1 hour total) each week with a physical therapist or trained member of the research team. Training sessions will focus on progression of aerobic and strength training exercises.', 'interventionNames': ['Behavioral: In-Person Delivered Exercise Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Telephone-Delivered Exercise', 'description': 'Participants in the telephone-delivered training group will:\n\n1. participate in a home exercise program including aerobic training 2x/week and strength training 3x/week.\n2. receive a 60-minute, 1x/week telephone call from a trained research team member. Participants will report their progress from the prior week, discuss/troubleshoot any issues or problems, and receive progressions of both aerobic and strength training exercises for the upcoming week.', 'interventionNames': ['Behavioral: Telephone-Delivered Exercise Therapy']}], 'interventions': [{'name': 'Telephone-Delivered Exercise Therapy', 'type': 'BEHAVIORAL', 'description': 'A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.\n\nAerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be given a wrist-worn pedometer with heart-rate monitor to track their heart rate during training. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.\n\nStrength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week.\n\nThis home exercise program will be paired with a 1x/week telephone call with an investigator.', 'armGroupLabels': ['Telephone-Delivered Exercise']}, {'name': 'In-Person Delivered Exercise Therapy', 'type': 'BEHAVIORAL', 'description': 'A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.\n\nAerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be given a wrist-worn pedometer with heart-rate monitor to track their heart rate during training. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.\n\nStrength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week.\n\nThis home exercise program will be paired with a 1x/week visit to the laboratory to work with a physical therapist or trained team member.', 'armGroupLabels': ['In-Person Delivered Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wayne State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Multiple Sclerosis Society', 'class': 'OTHER'}, {'name': 'University of Michigan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nora Fritz', 'investigatorAffiliation': 'Wayne State University'}}}}