Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2026-02-28 @ 7:30 AM
Study NCT ID:
NCT02494518
Status:
COMPLETED
Last Update Posted:
2019-03-28
First Post:
2015-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Forced Aerobic Exercise for Stroke Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'linders@ccf.org', 'phone': '(216) 445-9815', 'title': 'Dr. Susan Linder', 'organization': 'Cleveland Clinic'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '12 weeks from baseline assessment', 'eventGroups': [{'id': 'EG000', 'title': 'Forced Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nForced Exercise \\& Upper Extremity Repetitive Task Practice', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 1, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Voluntary Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nVoluntary Exercise \\& Upper Extremity Repetitive Task Practice', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Stroke Education & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of stroke education\n2. 45 minutes of upper extremity repetitive arm exercises\n\nStroke Education \\& Upper Extremity Repetitive Task Practice', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Skin Integrity', 'notes': 'One participant developed a blister after forced exercise. The blister was monitored and did not require follow up care.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Fall', 'notes': 'One participant fell during 6MWT administration, resulting in superficial injuries that did not require follow up care.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 12, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fugl Meyer Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Forced Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nForced Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'OG001', 'title': 'Voluntary Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nVoluntary Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'OG002', 'title': 'Stroke Education & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of stroke education\n2. 45 minutes of upper extremity repetitive arm exercises\n\nStroke Education \\& Upper Extremity Repetitive Task Practice'}], 'classes': [{'title': 'Baseline to Midpoint', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.90', 'spread': '5.55', 'groupId': 'OG000'}, {'value': '4.00', 'spread': '3.27', 'groupId': 'OG001'}, {'value': '6.25', 'spread': '3.65', 'groupId': 'OG002'}]}]}, {'title': 'Baseline to EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.10', 'spread': '5.32', 'groupId': 'OG000'}, {'value': '6.50', 'spread': '3.47', 'groupId': 'OG001'}, {'value': '8.88', 'spread': '4.76', 'groupId': 'OG002'}]}]}, {'title': 'Baseline to EOT+4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.11', 'spread': '5.69', 'groupId': 'OG000'}, {'value': '7.10', 'spread': '4.51', 'groupId': 'OG001'}, {'value': '9.25', 'spread': '5.75', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends', 'description': 'Motor test to assess arm impairment. The reported data is the change in total score. Score range from 0-66 and higher scores represent less impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4'}, {'type': 'PRIMARY', 'title': 'Wolf Motor Function Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Forced Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nForced Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'OG001', 'title': 'Voluntary Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nVoluntary Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'OG002', 'title': 'Stroke Education & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of stroke education\n2. 45 minutes of upper extremity repetitive arm exercises\n\nStroke Education \\& Upper Extremity Repetitive Task Practice'}], 'classes': [{'title': 'Baseline to EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.80', 'spread': '6.09', 'groupId': 'OG000'}, {'value': '6.40', 'spread': '3.17', 'groupId': 'OG001'}, {'value': '10.50', 'spread': '6.87', 'groupId': 'OG002'}]}]}, {'title': 'Baseline to EOT+4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.22', 'spread': '6.67', 'groupId': 'OG000'}, {'value': '9.60', 'spread': '2.59', 'groupId': 'OG001'}, {'value': '10.88', 'spread': '6.77', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends', 'description': 'Motor test to assess arm function. The reported data is the change in total Functional Ability Score. Scores range from 0-75 and higher scores represent improved function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4'}, {'type': 'PRIMARY', 'title': 'Stroke Impact Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Forced Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nForced Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'OG001', 'title': 'Voluntary Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nVoluntary Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'OG002', 'title': 'Stroke Education & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of stroke education\n2. 45 minutes of upper extremity repetitive arm exercises\n\nStroke Education \\& Upper Extremity Repetitive Task Practice'}], 'classes': [{'title': 'Baseline to EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.00', 'spread': '11.55', 'groupId': 'OG000'}, {'value': '14.50', 'spread': '14.03', 'groupId': 'OG001'}, {'value': '9.38', 'spread': '12.08', 'groupId': 'OG002'}]}]}, {'title': 'Baseline to EOT+4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.44', 'spread': '12.10', 'groupId': 'OG000'}, {'value': '14.00', 'spread': '20.25', 'groupId': 'OG001'}, {'value': '21.25', 'spread': '19.04', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends', 'description': 'Quality of life questionnaire. The reported data is the normalized Hand Function score. Scores range from 0-100, with higher scores indicating better perceived hand function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4'}, {'type': 'PRIMARY', 'title': 'Metabolic Stress Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Forced Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nForced Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'OG001', 'title': 'Voluntary Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nVoluntary Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'OG002', 'title': 'Stroke Education & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of stroke education\n2. 45 minutes of upper extremity repetitive arm exercises\n\nStroke Education \\& Upper Extremity Repetitive Task Practice'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '1.35', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '1.70', 'groupId': 'OG001'}, {'value': '0.40', 'spread': '0.70', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to follow up assessments at end of 8 week intervention', 'description': 'Cycling test to measure cardiovascular fitness. The data reported is the change in VO2peak. Higher scores indicate higher aerobic capacities.', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Action Research Arm Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Forced Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nForced Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'OG001', 'title': 'Voluntary Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nVoluntary Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'OG002', 'title': 'Stroke Education & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of stroke education\n2. 45 minutes of upper extremity repetitive arm exercises\n\nStroke Education \\& Upper Extremity Repetitive Task Practice'}], 'classes': [{'title': 'Baseline to EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.60', 'spread': '6.24', 'groupId': 'OG000'}, {'value': '6.30', 'spread': '4.83', 'groupId': 'OG001'}, {'value': '6.38', 'spread': '4.96', 'groupId': 'OG002'}]}]}, {'title': 'Baseline to EOT+4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.56', 'spread': '4.98', 'groupId': 'OG000'}, {'value': '7.50', 'spread': '5.50', 'groupId': 'OG001'}, {'value': '7.13', 'spread': '4.52', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends', 'description': 'Motor test to assess arm function. The reported data is change in total score. Scores range from 0-57, and higher scores indicate better function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4'}, {'type': 'SECONDARY', 'title': 'Center for Epidemiological Studies-Depression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Forced Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nForced Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'OG001', 'title': 'Voluntary Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nVoluntary Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'OG002', 'title': 'Stroke Education & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of stroke education\n2. 45 minutes of upper extremity repetitive arm exercises\n\nStroke Education \\& Upper Extremity Repetitive Task Practice'}], 'classes': [{'title': 'Baseline to EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.20', 'spread': '7.44', 'groupId': 'OG000'}, {'value': '-0.30', 'spread': '8.31', 'groupId': 'OG001'}, {'value': '-2.00', 'spread': '5.53', 'groupId': 'OG002'}]}]}, {'title': 'Baseline to EOT+4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.67', 'spread': '6.63', 'groupId': 'OG000'}, {'value': '-2.60', 'spread': '5.46', 'groupId': 'OG001'}, {'value': '-3.75', 'spread': '7.21', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends', 'description': 'Depression questionnaire. The reported data is change in total score. Scores range from 0-60, and lower scores indicate decreased risk of depression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4'}, {'type': 'SECONDARY', 'title': 'Processing Speed Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Forced Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nForced Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'OG001', 'title': 'Voluntary Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nVoluntary Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'OG002', 'title': 'Stroke Education & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of stroke education\n2. 45 minutes of upper extremity repetitive arm exercises\n\nStroke Education \\& Upper Extremity Repetitive Task Practice'}], 'classes': [{'title': 'Baseline to EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.90', 'spread': '4.68', 'groupId': 'OG000'}, {'value': '1.88', 'spread': '4.22', 'groupId': 'OG001'}, {'value': '2.71', 'spread': '6.32', 'groupId': 'OG002'}]}]}, {'title': 'Baseline to EOT+4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.89', 'spread': '7.52', 'groupId': 'OG000'}, {'value': '3.25', 'spread': '5.15', 'groupId': 'OG001'}, {'value': '6.38', 'spread': '10.27', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends', 'description': 'Matching letters and symbols to test cognition. The reported data is change in total number correct.', 'unitOfMeasure': 'number correct', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4'}, {'type': 'SECONDARY', 'title': 'Nine Hole Peg Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Forced Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nForced Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'OG001', 'title': 'Voluntary Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nVoluntary Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'OG002', 'title': 'Stroke Education & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of stroke education\n2. 45 minutes of upper extremity repetitive arm exercises\n\nStroke Education \\& Upper Extremity Repetitive Task Practice'}], 'classes': [{'title': 'Baseline to EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.07', 'spread': '15.71', 'groupId': 'OG000'}, {'value': '-16.15', 'spread': '45.64', 'groupId': 'OG001'}, {'value': '-19.35', 'spread': '21.51', 'groupId': 'OG002'}]}]}, {'title': 'Baseline to EOT+4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.10', 'spread': '10.58', 'groupId': 'OG000'}, {'value': '-7.81', 'spread': '34.89', 'groupId': 'OG001'}, {'value': '-29.15', 'spread': '32.75', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends', 'description': 'Transferring pegs into a fitted hole to measure hand function. The reported data is change in average time to complete.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'One individual in FE+RTP completed EOT but was lost to follow-up and did not complete EOT+4. One individual in VE+RTP did not complete the NHPT at EOT+4.'}, {'type': 'SECONDARY', 'title': 'Six Minute Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Forced Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nForced Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'OG001', 'title': 'Voluntary Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nVoluntary Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'OG002', 'title': 'Stroke Education & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of stroke education\n2. 45 minutes of upper extremity repetitive arm exercises\n\nStroke Education \\& Upper Extremity Repetitive Task Practice'}], 'classes': [{'title': 'Baseline to EOT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '133.20', 'spread': '107.78', 'groupId': 'OG000'}, {'value': '188.70', 'spread': '155.22', 'groupId': 'OG001'}, {'value': '-21.75', 'spread': '111.76', 'groupId': 'OG002'}]}]}, {'title': 'Baseline to EOT+4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '78.50', 'spread': '224.32', 'groupId': 'OG000'}, {'value': '127.70', 'spread': '190.05', 'groupId': 'OG001'}, {'value': '78.88', 'spread': '202.38', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends', 'description': 'Distance walked in 6 minutes to measure cardiovascular fitness. The reported data is change in total distance traveled.', 'unitOfMeasure': 'feet', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Two individuals in FE+RTP did not complete this assessment at EOT+4'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Forced Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nForced Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'FG001', 'title': 'Voluntary Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nVoluntary Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'FG002', 'title': 'Stroke Education & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of stroke education\n2. 45 minutes of upper extremity repetitive arm exercises\n\nStroke Education \\& Upper Extremity Repetitive Task Practice'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Forced Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nForced Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'BG001', 'title': 'Voluntary Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises\n\nVoluntary Exercise \\& Upper Extremity Repetitive Task Practice'}, {'id': 'BG002', 'title': 'Stroke Education & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of stroke education\n2. 45 minutes of upper extremity repetitive arm exercises\n\nStroke Education \\& Upper Extremity Repetitive Task Practice'}, {'id': 'BG003', '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '54.91', 'spread': '10.69', 'groupId': 'BG000'}, {'value': '59.33', 'spread': '13.84', 'groupId': 'BG001'}, {'value': '60.45', 'spread': '11.25', 'groupId': 'BG002'}, {'value': '58.26', 'spread': '11.94', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Fugl-Meyer Assessment', 'classes': [{'categories': [{'measurements': [{'value': '35.73', 'spread': '8.71', 'groupId': 'BG000'}, {'value': '35.92', 'spread': '10.11', 'groupId': 'BG001'}, {'value': '32.09', 'spread': '7.44', 'groupId': 'BG002'}, {'value': '34.62', 'spread': '8.77', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Motor test to assess arm impairment. Scores range from 0-66 and higher scores represent less impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Wolf Motor Function Test', 'classes': [{'categories': [{'measurements': [{'value': '55.09', 'spread': '12.19', 'groupId': 'BG000'}, {'value': '52.83', 'spread': '9.49', 'groupId': 'BG001'}, {'value': '51.91', 'spread': '8.79', 'groupId': 'BG002'}, {'value': '53.26', 'spread': '10.02', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Motor test to assess arm function. The reported data is the total Functional Ability Score. Scores range from 0-75 and higher scores represent improved function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Stroke Impact Scale', 'classes': [{'categories': [{'measurements': [{'value': '53.64', 'spread': '23.46', 'groupId': 'BG000'}, {'value': '51.67', 'spread': '18.13', 'groupId': 'BG001'}, {'value': '54.09', 'spread': '20.23', 'groupId': 'BG002'}, {'value': '53.09', 'spread': '20.04', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Quality of life questionnaire. The reported data is the normalized Hand Function score. Scores range from 0-100, with higher scores indicating better perceived hand function.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Metabolic Stress Test', 'classes': [{'categories': [{'measurements': [{'value': '15.23', 'spread': '3.84', 'groupId': 'BG000'}, {'value': '16.72', 'spread': '4.06', 'groupId': 'BG001'}, {'value': '14.58', 'spread': '3.48', 'groupId': 'BG002'}, {'value': '15.54', 'spread': '3.81', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Cycling test to measure cardiovascular fitness. The data reported is VO2peak. Higher scores indicate higher aerobic capacities.', 'unitOfMeasure': 'mL/kg/min', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-04-25', 'size': 647707, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-06-08T11:33', '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': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-20', 'studyFirstSubmitDate': '2015-07-06', 'resultsFirstSubmitDate': '2018-06-08', 'studyFirstSubmitQcDate': '2015-07-08', 'lastUpdatePostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-20', 'studyFirstPostDateStruct': {'date': '2015-07-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl Meyer Assessment', 'timeFrame': 'Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends', 'description': 'Motor test to assess arm impairment. The reported data is the change in total score. Score range from 0-66 and higher scores represent less impairment.'}, {'measure': 'Wolf Motor Function Test', 'timeFrame': 'Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends', 'description': 'Motor test to assess arm function. The reported data is the change in total Functional Ability Score. Scores range from 0-75 and higher scores represent improved function.'}, {'measure': 'Stroke Impact Scale', 'timeFrame': 'Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends', 'description': 'Quality of life questionnaire. The reported data is the normalized Hand Function score. Scores range from 0-100, with higher scores indicating better perceived hand function.'}, {'measure': 'Metabolic Stress Test', 'timeFrame': 'Change from baseline to follow up assessments at end of 8 week intervention', 'description': 'Cycling test to measure cardiovascular fitness. The data reported is the change in VO2peak. Higher scores indicate higher aerobic capacities.'}], 'secondaryOutcomes': [{'measure': 'Action Research Arm Test', 'timeFrame': 'Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends', 'description': 'Motor test to assess arm function. The reported data is change in total score. Scores range from 0-57, and higher scores indicate better function.'}, {'measure': 'Center for Epidemiological Studies-Depression', 'timeFrame': 'Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends', 'description': 'Depression questionnaire. The reported data is change in total score. Scores range from 0-60, and lower scores indicate decreased risk of depression.'}, {'measure': 'Processing Speed Test', 'timeFrame': 'Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends', 'description': 'Matching letters and symbols to test cognition. The reported data is change in total number correct.'}, {'measure': 'Nine Hole Peg Test', 'timeFrame': 'Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends', 'description': 'Transferring pegs into a fitted hole to measure hand function. The reported data is change in average time to complete.'}, {'measure': 'Six Minute Walk Test', 'timeFrame': 'Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends', 'description': 'Distance walked in 6 minutes to measure cardiovascular fitness. The reported data is change in total distance traveled.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stroke', 'aerobic exercise', 'forced exercise', 'repetitive task practice', 'arm function', 'upper extremity'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '32918907', 'type': 'DERIVED', 'citation': 'Linder SM, Davidson S, Rosenfeldt A, Lee J, Koop MM, Bethoux F, Alberts JL. Forced and Voluntary Aerobic Cycling Interventions Improve Walking Capacity in Individuals With Chronic Stroke. Arch Phys Med Rehabil. 2021 Jan;102(1):1-8. doi: 10.1016/j.apmr.2020.08.006. Epub 2020 Sep 9.'}, {'pmid': '31778659', 'type': 'DERIVED', 'citation': 'Linder SM, Davidson S, Rosenfeldt A, Penko A, Lee J, Koop MM, Phelan D, Alberts JL. Predictors of Improved Aerobic Capacity in Individuals With Chronic Stroke Participating in Cycling Interventions. Arch Phys Med Rehabil. 2020 Apr;101(4):717-721. doi: 10.1016/j.apmr.2019.10.187. Epub 2019 Nov 25.'}, {'pmid': '30543801', 'type': 'DERIVED', 'citation': 'Rosenfeldt AB, Linder SM, Davidson S, Clark C, Zimmerman NM, Lee JJ, Alberts JL. Combined Aerobic Exercise and Task Practice Improve Health-Related Quality of Life Poststroke: A Preliminary Analysis. Arch Phys Med Rehabil. 2019 May;100(5):923-930. doi: 10.1016/j.apmr.2018.11.011. Epub 2018 Dec 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine if performing different types of aerobic exercise (cycling) before upper extremity exercises will help to improve outcomes after stroke.', 'detailedDescription': "The goal of this study is to determine the potential for forced aerobic exercise to augment the recovery of motor function in individuals with stroke. Current approaches to stroke rehabilitation involve intensive, therapist-directed task practice that is both expensive and in some cases, ineffective in fostering functional neuromotor recovery. The identification of a safe, cost-effective approach, such as forced aerobic exercise, to augment the recovery of function achieved through task practice while simultaneously decreasing the cardiovascular risk factors prevalent in stroke survivors would be significant to rehabilitation and stroke communities.\n\nAnimal studies along with preliminary human data indicate a specific type of aerobic exercise (AE), forced aerobic exercise (FE), may be ideal in facilitating motor recovery associated with repetitive task practice (RTP). The hypothesis is that that deficits in afferent input and motor cortical output following stroke prevents patients from achieving and maintaining an exercise intensity that is sufficient for facilitating motor recovery; therefore, FE is needed to augment their voluntary efforts and achieve greater gains in recovery. In previous research, a safe lower extremity FE intervention was initially applied to individuals with Parkinson's disease and subsequently to individuals with stroke. Preliminary results indicate that those completing an 8-week FE intervention paired with an abbreviated session of RTP exhibited significantly greater improvement in Fugl-Meyer scores at end of treatment despite completing 40% fewer RTP repetitions, compared to those receiving voluntary-rate aerobic exercise (VE) and RTP and time-matched RTP only. Improvements in cardiovascular fitness and lower extremity motor function were also evident in both groups that engaged in aerobic exercise (FE and VE). Positive results from a preliminary trial indicate safety, feasibility, and initial efficacy of combining two modes of aerobic exercise training with RTP provide rationale for a systematic and larger scale trial to determine the precise role of aerobic exercise, forced and voluntary, in facilitating motor recovery following stroke.\n\nFor this study, 30 individuals with chronic stroke will be randomized into one of the following groups: FE = RTP, VE + RTP or patient education and RTP. All three groups will receive an identical dose of contact time over 8 weeks (3X per week). An intervention group receiving a 45-minute session of patient education paired with RTP will serve as the non-exercise control. Clinical and biomechanical outcomes measuring change in upper extremity motor function, lower extremity motor function, and cardiovascular fitness will provide the most complete picture, to date, on the potential neurologic effects of AE (forced and voluntary) on motor recovery and brain function in humans with stroke."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Able to provide informed consent\n* At least 6 months post diagnosis of single ischemic stroke, confirmed with neuroimaging\n* Fugl-Meyer Motor Score 19-55 in involved upper extremity\n* Approval from patient's physician\n* Age between 18 and 85 years\n\nExclusion Criteria:\n\n* Hospitalization for myocardial infarction, congestive heart failure, or heart surgery (CABG or valve replacement) within 3 months of study enrollment\n* Serious cardiac arrhythmia\n* Other serious heart and lung conditions (i.e.cardiomyopathy, aortic stenosis, cardiac pacemaker, pulmonary embolus)\n* Other medical or musculoskeletal contraindication to exercise\n* Significant cognitive impairment (unable to follow 1-2 step commands) or major psychiatric disorder (major depression, generalized anxiety) that will cause difficulty in study participation\n* Anti-spasticity injection (botox) in upper extremity within 3 months of study enrollment\n* Pregnancy\n* Unstable blood pressure at rest or with exercise"}, 'identificationModule': {'nctId': 'NCT02494518', 'briefTitle': 'Forced Aerobic Exercise for Stroke Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Forced Aerobic Exercise for Stroke Rehabilitation', 'orgStudyIdInfo': {'id': '12-402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Forced Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises', 'interventionNames': ['Behavioral: Forced Exercise & Upper Extremity Repetitive Task Practice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Voluntary Exercise & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed\n2. 45 minutes of upper extremity repetitive arm exercises', 'interventionNames': ['Behavioral: Voluntary Exercise & Upper Extremity Repetitive Task Practice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Stroke Education & Upper Extremity Repetitive Task Practice', 'description': 'Participants will perform the following:\n\n1. 45 minutes of stroke education\n2. 45 minutes of upper extremity repetitive arm exercises', 'interventionNames': ['Behavioral: Stroke Education & Upper Extremity Repetitive Task Practice']}], 'interventions': [{'name': 'Forced Exercise & Upper Extremity Repetitive Task Practice', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Forced Exercise & Upper Extremity Repetitive Task Practice']}, {'name': 'Voluntary Exercise & Upper Extremity Repetitive Task Practice', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Voluntary Exercise & Upper Extremity Repetitive Task Practice']}, {'name': 'Stroke Education & Upper Extremity Repetitive Task Practice', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Stroke Education & Upper Extremity Repetitive Task Practice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Susan Linder, PT, DPT, NCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Heart Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Physical Therapist', 'investigatorFullName': 'Susan Linder', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}