Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-02 @ 7:52 AM
Study NCT ID:
NCT04906057
Status:
COMPLETED
Last Update Posted:
2025-03-06
First Post:
2021-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Therapeutic Effects of Forced Aerobic Exercise in Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'harrisD47@ccf.org', 'phone': '2164454125', 'title': 'Donayja Harris', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse experiences were collected up to 19 weeks from start to completion of the study.', 'eventGroups': [{'id': 'EG000', 'title': 'Forced Aerobic Exercise (FE)', 'description': "This section includes data from all randomized participants in the forced exercise group\n\nThe FE group (N=12) completed 45 minutes of FE on the custom-engineered cycle designed to augment the pedaling rate to greater than 70 revolutions per minute (RPM's). The VE group (N=10) will exercise on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance.\n\nForced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer", 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 2, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Voluntary Aerobic Exercise (VE)', 'description': 'This section includes data from all randomized participants in the the voluntary exercise group\n\nThe VE group (N=10) completed the exercise on an identical semi-recumbent cycle ergometer for 45 minutes at their self-selected cadence without assistance.\n\nVoluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometer', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 4, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Covid-19 Diagnosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'STEMI', 'notes': 'Heart attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 12, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Exercise Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Forced Aerobic Exercise (FE)', 'description': "Results from this section include data from the Forced Exercise\n\nThe FE group completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).\n\nForced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer"}, {'id': 'OG001', 'title': 'Voluntary Exercise (VE)', 'description': 'The VE group completed exercises on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.\n\nVoluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometercle ergometer'}], 'classes': [{'categories': [{'measurements': [{'value': '42.2', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '42.2', 'spread': '2.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'collected during each exercise session (twice per week for 12 weeks)', 'description': 'Average exercise duration', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Completed participants in the FE \\& VE groups.'}, {'type': 'PRIMARY', 'title': 'Aerobic Intensity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Forced Aerobic Exercise (FE)', 'description': "Results from this section include data from the Forced Exercise group.\n\nThe FE group completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).\n\nForced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer"}, {'id': 'OG001', 'title': 'Voluntary Exercise (VE)', 'description': 'The VE group completed exercises on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.\n\nVoluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometercle ergometer'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'spread': '0.07', 'groupId': 'OG000'}, {'value': '.70', 'spread': '0.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Collected during each exercise session (twice per week for 12 weeks)', 'description': 'average percent max heart rate', 'unitOfMeasure': '% Max HR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FE + VE groups'}, {'type': 'PRIMARY', 'title': 'Exercise Cadence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Forced Aerobic Exercise (FE)', 'description': "Results from this section includes data the Forced Exercise.\n\nThe FE group completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).\n\nForced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer"}, {'id': 'OG001', 'title': 'Voluntary Exercise (VE)', 'description': 'The VE group completed exercises on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.\n\nVoluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometercle ergometer'}], 'classes': [{'categories': [{'measurements': [{'value': '69.1', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '64.5', 'spread': '16.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'collected during each exercise session (twice per week for 12 weeks)', 'description': 'Average Exercise Cadence (cycling rate)', 'unitOfMeasure': 'revolutions per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Completed participants within the FE \\& VE groups'}, {'type': 'PRIMARY', 'title': 'Six Minute Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Forced Aerobic Exercise (FE)', 'description': "The FE group completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).\n\nForced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer"}, {'id': 'OG001', 'title': 'Voluntary Exercise', 'description': 'The VE group completed exercises on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.\n\nVoluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometer'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '339.1', 'spread': '123.3', 'groupId': 'OG000'}, {'value': '345.9', 'spread': '110.7', 'groupId': 'OG001'}]}]}, {'title': 'EOT', 'categories': [{'measurements': [{'value': '338.3', 'spread': '111.5', 'groupId': 'OG000'}, {'value': '373.6', 'spread': '128.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 (baseline), Week 13 (post exercise sessions)', 'description': 'The distance walked over 6 minutes is measured on an oval walking track', 'unitOfMeasure': 'Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Week (0) Baseline + EOT Week (13)'}, {'type': 'PRIMARY', 'title': 'Gait Velocity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Forced Aerobic Exercise (FE)', 'description': "Results from this section includes data from both the Forced Exercise and the Voluntary Exercise Group.\n\nThe FE group completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).\n\nForced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer"}, {'id': 'OG001', 'title': 'Voluntary Exercise', 'description': 'The VE group completed exercises on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.\n\nVoluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometer'}], 'classes': [{'title': 'Zeno Velocity Self-Paced Baseline (average)', 'categories': [{'measurements': [{'value': '90.6', 'spread': '17.3', 'groupId': 'OG000'}, {'value': '91.5', 'spread': '30.6', 'groupId': 'OG001'}]}]}, {'title': 'Zeno Velocity Fast-Paced Baseline (average)', 'categories': [{'measurements': [{'value': '122.4', 'spread': '19.3', 'groupId': 'OG000'}, {'value': '131.0', 'spread': '13.0', 'groupId': 'OG001'}]}]}, {'title': 'CAREN Walking Speed Baseline (Average)', 'categories': [{'measurements': [{'value': '0.54', 'spread': '.28', 'groupId': 'OG000'}, {'value': '0.65', 'spread': '0.30', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 (baseline), Week 13 (post exercise sessions)', 'description': 'Spatio-temporal and kinematic parameters of gait will be obtained using 3-D motion capture and an instrumented walkway.', 'unitOfMeasure': 'Meters per second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was obtained using a ZENO \\& Caren walking pad; however, one participant was unable to complete this outcome measure due to unsteady gait.'}, {'type': 'PRIMARY', 'title': 'PROMIS-29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Forced Aerobic Exercise (FE) + Voluntary Exercise (VE)', 'description': "Results from this section includes data from both the Forced Exercise and the Voluntary Exercise Group.\n\nThe FE group completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).\n\nForced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer"}, {'id': 'OG001', 'title': 'Voluntary Exercise', 'description': 'The VE group completed exercises on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.\n\nVoluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometer'}], 'classes': [{'title': 'PROMIS Physical at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.2', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '40.8', 'spread': '7.8', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Physical at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '40.0', 'spread': '6.0', 'groupId': 'OG000'}, {'value': '40.0', 'spread': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Anxiety at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.6', 'spread': '7.6', 'groupId': 'OG000'}, {'value': '49.5', 'spread': '12.3', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Anxiety at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.8', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '45.6', 'spread': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Depression at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.1', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '46.5', 'spread': '10.8', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Depression at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.7', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '45.8', 'spread': '6.6', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Fatigue at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.8', 'spread': '11.5', 'groupId': 'OG000'}, {'value': '53.5', 'spread': '5.2', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Fatigue at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.6', 'spread': '11.0', 'groupId': 'OG000'}, {'value': '47.9', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Sleep Disturbance at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.2', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '45.8', 'spread': '9.8', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Sleep Disturbance at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '42.9', 'spread': '6.1', 'groupId': 'OG000'}, {'value': '44.9', 'spread': '7.8', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Participation at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '50.5', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '49.2', 'spread': '7.9', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Participation at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.6', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '52.0', 'spread': '8.1', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Pain Interference at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '52.7', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '54.9', 'spread': '7.2', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Pain Interference at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '46.5', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '50.1', 'spread': '7.7', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Pain Intensity at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '4.1', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'PROMIS Pain Intensity at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 (baseline), Week 13 (post exercise sessions)', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in the general population and with individuals living with chronic conditions. Raw scores were converted to T-scores (using an adult referent population) ranging from 0-100 with a mean of 50 and standard deviation (SD) of 10 in the referent population. For the PROMIS-29 symptom-related domains (anxiety, depression, fatigue, sleep disturbance, and pain interference), higher scores represent greater symptom burden (worse function). For the physical and participation domains, higher scores represent greater levels of function. Pain intensity is scored separately using a 0-10 scaler with higher scores representing greater pain.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participant completed the PROMIS-29 assessment at baseline. Some participants chose not to complete the EOT questionnaire, hence the overall number of participants for the EOT testing is fewer than the baseline.'}, {'type': 'PRIMARY', 'title': 'Modified Fatigue Impact Scale (MFIS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Forced Aerobic Exercise (FE)', 'description': "Results from this section includes data from both the Forced Exercise and the Voluntary Exercise Group.\n\nThe FE group completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).\n\nForced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer"}, {'id': 'OG001', 'title': 'Voluntary Exercise', 'description': 'The VE group completed exercises on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.\n\nVoluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometer'}], 'classes': [{'title': 'MFIS total score at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.9', 'spread': '18.5', 'groupId': 'OG000'}, {'value': '33.4', 'spread': '12.8', 'groupId': 'OG001'}]}]}, {'title': 'MFIS total score at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.6', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '20.2', 'spread': '7.5', 'groupId': 'OG001'}]}]}, {'title': 'MFIS Physical Subscale at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.0', 'spread': '10.6', 'groupId': 'OG000'}, {'value': '18.7', 'spread': '6.9', 'groupId': 'OG001'}]}]}, {'title': 'MFIS Physical Subscale at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.9', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '11.8', 'spread': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'MFIS Cognitive Subscale at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.6', 'spread': '7.4', 'groupId': 'OG000'}, {'value': '12.3', 'spread': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'MFIS Cognitive Subscale at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '6.6', 'groupId': 'OG001'}]}]}, {'title': 'MFIS Psychosocial Subscale at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.90', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'MFIS Psychosocial Subscale at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 (baseline), Week 13 (post exercise sessions)', 'description': "The MFIS is a 21-item self-reported measure of how fatigue impacts the lives of persons with multiple sclerosis. This instrument provides an assessment of the effects of fatigue as it relates to physical, cognitive, and psychosocial functioning. Participants rate on a 5-point Likert scale, with 0 = 'Never' to 4 = 'Almost always' their agreement with 21 statements. Total score (0-84) and subscales for physical (0-36), cognitive (0-40) and psychosocial functioning (0-8). Higher numbers indicate greater fatigue in all domains.", 'unitOfMeasure': 'score on Likert scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Each participant completed the Modified Fatigue Impact Scale (MFIS) assessment at baseline. Some participants chose not to complete the EOT questionnaire, hence the overall number of participants for the EOT testing is fewer than the baseline.'}, {'type': 'PRIMARY', 'title': 'Multiple Sclerosis Manual Dexterity Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Forced Aerobic Exercise (FE)', 'description': "The FE group completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).\n\nForced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer"}, {'id': 'OG001', 'title': 'Voluntary Exercise (VE)', 'description': 'The VE group completed exercises on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.\n\nVoluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometercle ergometer'}], 'classes': [{'title': 'Manual Dexterity Test (Right) at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '31.4', 'spread': '8.2', 'groupId': 'OG000'}, {'value': '24.3', 'spread': '4.1', 'groupId': 'OG001'}]}]}, {'title': 'Manual Dexterity Test (right) at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.4', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '23.9', 'spread': '4.4', 'groupId': 'OG001'}]}]}, {'title': 'Manual Dexterity Test (Left) at baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.8', 'spread': '5.8', 'groupId': 'OG000'}, {'value': '25.4', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Manual Dexterity Test (left) at EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.4', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '39.6', 'spread': '35.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 (baseline), Week 13 (post exercise sessions)', 'description': 'Assessment examining cognitive and hand function for persons with MS', 'unitOfMeasure': 'Time in Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One forced exercise participant was unable to complete the Manual Dexterity test on the left side at baseline.'}, {'type': 'PRIMARY', 'title': 'Processing Speed Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Forced Aerobic Exercise (FE)', 'description': "Results from this section includes data from both the Forced Exercise and the Voluntary Exercise Group.\n\nThe FE group completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).\n\nForced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer"}, {'id': 'OG001', 'title': 'Voluntary Exercise', 'description': 'The VE group completed exercises on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.\n\nVoluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometer'}], 'classes': [{'title': 'Processing speed test total correct at baseline', 'categories': [{'measurements': [{'value': '43.0', 'spread': '8.0', 'groupId': 'OG000'}, {'value': '55.3', 'spread': '8.5', 'groupId': 'OG001'}]}]}, {'title': 'Processing speed test total correct at EOT', 'categories': [{'measurements': [{'value': '45.1', 'spread': '9.4', 'groupId': 'OG000'}, {'value': '57.4', 'spread': '9.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0 (baseline), Week 13 (post exercise sessions)', 'description': 'Assessment examining processing speed using an tablet-based measure developed to closely resemble the symbol digit modalities test. Participants match symbols to digits over a 2-minute trial. The number of correct matches represents the score, with higher correct matches indicative of better processing speed performance. The low range of possible scoring is 0 with no upper range limit. In a study by Rao and colleagues (2017), persons with MS scored and average of 51.1 (+/- 11.9) on the first trial and 52.8 (+/- 2.0) on the second trial. One trial was conducted in this study.', 'unitOfMeasure': 'number correct', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant from the VE group could not complete the processing speed test.'}, {'type': 'SECONDARY', 'title': 'To Investigate the Role of Klotho in Promoting Neuroprotection.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Forced Aerobic Exercise (FE)', 'description': "Results from this section includes data from both the Forced Exercise and the Voluntary Exercise Group.\n\nThe FE group completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).\n\nForced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer"}, {'id': 'OG001', 'title': 'Voluntary Aerobic Exercise (VE)', 'description': 'The VE group completed exercises on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.\n\nVoluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometer'}], 'classes': [{'title': 'Klotho (Baseline Pre-Exercise)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1273.3', 'spread': '787.7', 'groupId': 'OG000'}, {'value': '1100.4', 'spread': '878.0', 'groupId': 'OG001'}]}]}, {'title': 'Klotho (Baseline Post-Exercise)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '929.5', 'spread': '661.1', 'groupId': 'OG000'}, {'value': '1166.4', 'spread': '745.4', 'groupId': 'OG001'}]}]}, {'title': 'Klotho (Final Session pre-exercise)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '948.3', 'spread': '550.2', 'groupId': 'OG000'}, {'value': '1019.4', 'spread': '608.7', 'groupId': 'OG001'}]}]}, {'title': 'Klotho (Final Session post-exercise)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1265.8', 'spread': '940.2', 'groupId': 'OG000'}, {'value': '154.4', 'spread': '1104.1', 'groupId': 'OG001'}]}]}, {'title': 'Neurofilament light (Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.6', 'spread': '7.5', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '7.3', 'groupId': 'OG001'}]}]}, {'title': 'Neurofilament light (Final Session)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.5', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '15.0', 'spread': '4.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 1 (exercise session 1), Week 12 (exercise session 24)', 'description': 'Laboratory Assessment: Blood draws will be conducted at 4 different points in time to determine the acute and long-term change in serum Klotho; at week one session one, pre- and post-exercise, and at the last session12-week exercise intervention, pre- and post-exercise.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants in this data set have completed the entire 12 weeks of the prescribed exercise session.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Forced Aerobic Exercise (FE)', 'description': "The FE group (N=11) completed 45 minutes of forced-rate aerobic exercise on a custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).\n\nForced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer"}, {'id': 'FG001', 'title': 'Voluntary Aerobic Exercise (VE)', 'description': 'The VE group (N=7) completed aerobic exercise on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance for 45 minutes.\n\nVoluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometer'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Forced Aerobic Exercise (FE)', 'description': "The FE group (N=11) completed 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's).\n\nForced Aerobic Exercise (FE): High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer"}, {'id': 'BG001', 'title': 'Voluntary Aerobic Exercise (VE)', 'description': 'The VE group (N=7) completed exercise on an identical semi-recumbent cycle ergometer for 45 minutes at their self-selected cadence without assistance.\n\nVoluntary Aerobic Exercise (VE): Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometer'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'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': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1. Participants withdrew due to unrelated injury\n2. Participants withdrew due to Covid-19\n\n1 Participant withdrew due to Covid-19'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.6', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '56.9', 'spread': '7.9', 'groupId': 'BG001'}, {'value': '54.9', 'spread': '10.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '1. Participants withdrew due to unrelated injury\n2. Participants withdrew due to Covid-19\n\n1 Participant withdrew due to Covid-19'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1. Participants withdrew due to unrelated injury\n2. Participants withdrew due to Covid-19\n\n1 Participant withdrew due to Covid-19'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1. Participants withdrew due to unrelated injury\n2. Participants withdrew due to Covid-19\n\n1 Participant withdrew due to Covid-19'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-15', 'size': 574260, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-07-18T13:17', 'hasProtocol': True}, {'date': '2021-07-15', 'size': 76644, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-07-18T13:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Group allocation will be concealed to the individual obtaining all outcomes of interest'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'rater-blind, prospective randomized trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2021-05-10', 'resultsFirstSubmitDate': '2023-08-30', 'studyFirstSubmitQcDate': '2021-05-24', 'lastUpdatePostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-10', 'studyFirstPostDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exercise Duration', 'timeFrame': 'collected during each exercise session (twice per week for 12 weeks)', 'description': 'Average exercise duration'}, {'measure': 'Aerobic Intensity', 'timeFrame': 'Collected during each exercise session (twice per week for 12 weeks)', 'description': 'average percent max heart rate'}, {'measure': 'Exercise Cadence', 'timeFrame': 'collected during each exercise session (twice per week for 12 weeks)', 'description': 'Average Exercise Cadence (cycling rate)'}, {'measure': 'Six Minute Walk Test', 'timeFrame': 'Week 0 (baseline), Week 13 (post exercise sessions)', 'description': 'The distance walked over 6 minutes is measured on an oval walking track'}, {'measure': 'Gait Velocity', 'timeFrame': 'Week 0 (baseline), Week 13 (post exercise sessions)', 'description': 'Spatio-temporal and kinematic parameters of gait will be obtained using 3-D motion capture and an instrumented walkway.'}, {'measure': 'PROMIS-29', 'timeFrame': 'Week 0 (baseline), Week 13 (post exercise sessions)', 'description': 'The Patient-Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in the general population and with individuals living with chronic conditions. Raw scores were converted to T-scores (using an adult referent population) ranging from 0-100 with a mean of 50 and standard deviation (SD) of 10 in the referent population. For the PROMIS-29 symptom-related domains (anxiety, depression, fatigue, sleep disturbance, and pain interference), higher scores represent greater symptom burden (worse function). For the physical and participation domains, higher scores represent greater levels of function. Pain intensity is scored separately using a 0-10 scaler with higher scores representing greater pain.'}, {'measure': 'Modified Fatigue Impact Scale (MFIS)', 'timeFrame': 'Week 0 (baseline), Week 13 (post exercise sessions)', 'description': "The MFIS is a 21-item self-reported measure of how fatigue impacts the lives of persons with multiple sclerosis. This instrument provides an assessment of the effects of fatigue as it relates to physical, cognitive, and psychosocial functioning. Participants rate on a 5-point Likert scale, with 0 = 'Never' to 4 = 'Almost always' their agreement with 21 statements. Total score (0-84) and subscales for physical (0-36), cognitive (0-40) and psychosocial functioning (0-8). Higher numbers indicate greater fatigue in all domains."}, {'measure': 'Multiple Sclerosis Manual Dexterity Test', 'timeFrame': 'Week 0 (baseline), Week 13 (post exercise sessions)', 'description': 'Assessment examining cognitive and hand function for persons with MS'}, {'measure': 'Processing Speed Test', 'timeFrame': 'Week 0 (baseline), Week 13 (post exercise sessions)', 'description': 'Assessment examining processing speed using an tablet-based measure developed to closely resemble the symbol digit modalities test. Participants match symbols to digits over a 2-minute trial. The number of correct matches represents the score, with higher correct matches indicative of better processing speed performance. The low range of possible scoring is 0 with no upper range limit. In a study by Rao and colleagues (2017), persons with MS scored and average of 51.1 (+/- 11.9) on the first trial and 52.8 (+/- 2.0) on the second trial. One trial was conducted in this study.'}], 'secondaryOutcomes': [{'measure': 'To Investigate the Role of Klotho in Promoting Neuroprotection.', 'timeFrame': 'Week 1 (exercise session 1), Week 12 (exercise session 24)', 'description': 'Laboratory Assessment: Blood draws will be conducted at 4 different points in time to determine the acute and long-term change in serum Klotho; at week one session one, pre- and post-exercise, and at the last session12-week exercise intervention, pre- and post-exercise.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['aerobic exercise', 'gait'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This project will investigate the feasibility and initial efficacy of two aerobic exercise training approaches, forced and voluntary, to improve motor function in persons with multiple sclerosis (MS). We hypothesize that intensive aerobic exercise training elicits a neurorepairative and neurorestorative response on the central nervous system, which may improve motor function as it relates to gait and mobility. Should aerobic cycling, forced or voluntary, improve gait and functional mobility in persons with MS, it would serve as a new model to restoring function, rather than current models that focus on compensation.', 'detailedDescription': "Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease of the central nervous system characterized by progressive loss of motor function, cognitive function, in addition to symptoms of fatigue and depression. These motor and non-motor symptoms negatively affect the individuals' walking ability, functional mobility, quality of life, ability to maintain gainful employment, and social engagement. Identifying rehabilitation approaches that may delay disease progression or restore lost neurologic function would have considerable impact in the field. The goal of this project is to investigate the feasibility and initial efficacy of forced or voluntary aerobic exercise training to improve gait, functional mobility, fatigue and quality of life in persons with multiple sclerosis (PwMS). Current rehabilitative approaches for PwMS focus on training compensatory strategies rather than restoring neurological function. Substantial evidence indicates that aerobic exercise (AE) training has the potential to enhance neurological function by restoring and repairing damaged cells, leading to improvements in gait, balance, and cognitive function in PwMS. Despite evidence of the potential disease-modifying properties of AE, numerous physical, behavioral, and logistical barriers prevent PwMS from achieving and maintaining AE of sufficient intensity and duration to capitalize on the neurophysiologic benefits of training. Forced exercise (FE) is a novel approach to AE training that has been successfully applied to individuals with Parkinson's disease and stroke, in which the voluntary efforts of the individual are augmented, allowing for disease-altering effects of intensive exercise training. During FE, pedaling cadence on a stationary cycle is augmented by a motor to assist, but not replace, the voluntary efforts of the individual. It is hypothesized that PwMS cannot sustain high rates of voluntary exercise necessary to elicit neural repair; therefore, FE is necessary to overcome physical, behavioral and logistical barriers to enhance neuroplasticity to improve gait, QOL, and the ability to participate in life activities. Positive results from our FE trials in Parkinson's disease and stroke have guided us in designing the scientific methodology for the proposed trial in PwMS. Twenty adults with relapsing-remitting MS and mild to moderate gait impairment will be randomized to undergo 1) FE or 2) voluntary aerobic exercise (VE). Both groups will attend 2X/week for 12 weeks. Exercise variables will be collected for each session as a measure of feasibility to determine how PwMS respond to each exercise approach. Clinical, biomechanical, and self-reported outcomes will be gathered prior to, after, and 4-weeks after the intervention to determine the effects of both modes of exercise on spatiotemporal and kinematic characteristics of gait, functional mobility, balance, fatigue, physical activity levels, and quality of life. Should our findings confirm our hypothesis that intensive exercise training can have disease-altering effects, a new direction for MS rehabilitation approaches would ensue, empowering PwMS to take control of their disease to improve function and reduce disability."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Participants identifying as male or female are eligible', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Confirmed diagnosis of RRMS with Expanded Disability Status Scale (EDSS) score between 1.5 and 6.5,\n2. 18-75 years of age,\n3. Deemed minimal risk for cardiovascular event using American College of Sports Medicine Exercise Pre-participation Criteria\n\nExclusion Criteria:\n\n1. hospitalization for myocardial infarction, heart failure or heart surgery within 3 months,\n2. serious cardiac arrhythmia,\n3. hypertrophic cardiomyopathy,\n4. severe aortic stenosis,\n5. pulmonary embolus,\n6. significant contractures,\n7. dysphagia resulting in inability to sufficiently hydrate, and\n8. other contraindication to exercise.'}, 'identificationModule': {'nctId': 'NCT04906057', 'briefTitle': 'The Therapeutic Effects of Forced Aerobic Exercise in Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'The Therapeutic Effects of Forced Aerobic Exercise in Multiple Sclerosis', 'orgStudyIdInfo': {'id': '19-1003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Forced Aerobic Exercise (FE)', 'description': "The FE group (N=10) will complete 45 minutes of FE on the custom-engineered cycle designed to augment pedaling rate to greater than 70 revolutions per minute (RPM's). The VE group (N=10) will exercise on an identical semi-recumbent cycle ergometer at their self-selected cadence without assistance.", 'interventionNames': ['Behavioral: Forced Aerobic Exercise (FE)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Voluntary Aerobic Exercise (VE)', 'description': 'The VE group (N=10) will exercise on an identical semi-recumbent cycle ergometer for 45 minutes at their self-selected cadence without assistance.', 'interventionNames': ['Behavioral: Voluntary Aerobic Exercise (VE)']}], 'interventions': [{'name': 'Forced Aerobic Exercise (FE)', 'type': 'BEHAVIORAL', 'description': 'High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer', 'armGroupLabels': ['Forced Aerobic Exercise (FE)']}, {'name': 'Voluntary Aerobic Exercise (VE)', 'type': 'BEHAVIORAL', 'description': 'Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometer', 'armGroupLabels': ['Voluntary Aerobic Exercise (VE)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Main Campus', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Susan M Linder, DPT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Staff, Physical Medicine and Rehabilitation', 'investigatorFullName': 'Susan Linder', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}