Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT03479632
Status:
UNKNOWN
Last Update Posted:
2019-03-08
First Post:
2018-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2020-03-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-07', 'studyFirstSubmitDate': '2018-03-19', 'studyFirstSubmitQcDate': '2018-03-19', 'lastUpdatePostDateStruct': {'date': '2019-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Resting Heart Rate', 'timeFrame': 'Change from Baseline to Week 8'}], 'secondaryOutcomes': [{'measure': 'Resting blood pressure', 'timeFrame': 'Change from Baseline to Week 8'}, {'measure': 'Change in vital capacity (VC)', 'timeFrame': 'Change from Baseline to Week 8'}, {'measure': 'Change in forced vital capacity (FVC)', 'timeFrame': 'Change from Baseline to Week 8'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'By doing this study, researchers hope to learn the effects of aerobic exercise on heart, lung, and bone health in people who cannot walk after a stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Independent ambulation before stroke\n* Be able to understand and follow verbal commands in English\n* Have physicians' approval for exercise, and be in stable medical condition\n* Participant's first stroke\n* Unable to walk independently according to Functional Ambulation Category (FAC) (\\<2) after in-patient rehabilitation treatment\n* Between 6 weeks to 5 years after stroke onset\n\nExclusion Criteria:\n\n* Current cardiovascular abnormalities other than stroke such as ischemic cardiovascular event or coronary artery bypass surgery less than 3 months ago\n* Musculoskeletal disorder which prevents subjects from participating in the exercise\n* Resting blood pressure more than 200/110 mm Hg\n* Current or previous pulmonary diseases in the past two years\n* Osteoporosis and restricted passive movement in the major joints of the lower limbs\n* Subjects will be excluded if they are unable to speak or understand English and/or unable to travel to the University of Kansas Medical Center (KUMC) Neuromuscular Research Laboratory"}, 'identificationModule': {'nctId': 'NCT03479632', 'briefTitle': 'Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Aerobic Walking Exercise for Non-Ambulatory Stroke Survivors', 'orgStudyIdInfo': {'id': 'STUDY00140799'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'description': 'The intervention group will undergo an aerobic walking program using a treadmill, a body-weight support system, and an assistive device.', 'interventionNames': ['Behavioral: Aerobic walking program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'The control group will receive standard physical therapy (PT).', 'interventionNames': ['Behavioral: Standard physical therapy']}], 'interventions': [{'name': 'Aerobic walking program', 'type': 'BEHAVIORAL', 'description': 'Participants will make 24 visits over an 8 week period, having 3 sessions per week. Each session will last about one hour.', 'armGroupLabels': ['Intervention Group']}, {'name': 'Standard physical therapy', 'type': 'BEHAVIORAL', 'description': 'Participants will receive standard care they normally would after a stroke.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'centralContacts': [{'name': 'Abdulfattah Alqahtani', 'role': 'CONTACT', 'email': 'aalqahtani@kumc.edu', 'phone': '832-228-8799'}], 'overallOfficials': [{'name': 'Wen Liu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}