Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-01-14 @ 10:03 PM
Study NCT ID:
NCT02703805
Status:
COMPLETED
Last Update Posted:
2019-06-26
First Post:
2014-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fit For Function: A Community Wellness Program for Persons With Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 218}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-25', 'studyFirstSubmitDate': '2014-10-14', 'studyFirstSubmitQcDate': '2016-03-03', 'lastUpdatePostDateStruct': {'date': '2019-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Reintegration to Normal Living Index (RNL) from baseline', 'timeFrame': 'baseline, 12 weeks, 24 weeks', 'description': 'This measure assesses the degree to which individuals who have experienced traumatic or incapacitating illness achieve reintegration into normal social activities.'}], 'secondaryOutcomes': [{'measure': 'Change in The Rapid Assessment of Physical Activity (RAPA) score from baseline', 'timeFrame': 'baseline, 12 weeks, 24 weeks', 'description': 'This is a 9-item measure that assesses frequency and intensity of aerobic physical activity and frequency of strengthening and flexibility exercises.'}, {'measure': 'Change in The Short Portable Performance Tests (SPPT) score from baseline', 'timeFrame': 'baseline, 12 weeks, 24 weeks', 'description': 'This test is used to quantify lower extremity function by evaluating the time to walk 8 feet, standing balance and repeated chair stands.'}, {'measure': 'Change in The Six Minute Walk Test (6MWT) from baseline', 'timeFrame': 'baseline, 12 weeks, 24 weeks', 'description': 'This test is an indicator of exercise capacity and measures the distance walked in 6 minutes.'}, {'measure': 'Change in Strength: Grip and Knee extension from baseline', 'timeFrame': 'baseline, 12 weeks, 24 weeks', 'description': 'Hand-held dynamometry will measure the average strength of three trials.'}, {'measure': 'Change in The EQ-5D score from baseline', 'timeFrame': 'baseline, 12 weeks, 24 weeks', 'description': 'This is a generic utility-based health related quality of life questionnaire.'}, {'measure': 'Change in The Patient Activation Measure (PAM) score from baseline', 'timeFrame': 'baseline, 12 weeks, 24 weeks', 'description': "This is a 13-item measure of the patient's level of knowledge, skill and confidence for self-management."}, {'measure': 'Change in The Body Mass Index (BMI) score from baseline', 'timeFrame': 'baseline, 12 weeks, 24 weeks', 'description': 'The BMI will be calculated from measurements of body mass and height as an indicator of cardiovascular health.'}, {'measure': 'Change in Blood lipid levels from baseline', 'timeFrame': 'baseline, 12 weeks, 24 weeks', 'description': '12 hour fasting levels of lipids will be used as an indicator of cardiovascular health.'}, {'measure': 'Change in blood glucose levels from baseline', 'timeFrame': 'baseline, 12 weeks, 24 weeks', 'description': '12 hour fasting levels of glucose in blood will be used as an indicator of cardiovascular health.'}, {'measure': 'Change in blood inflammatory markers from baseline', 'timeFrame': 'baseline, 12 weeks, 24 weeks', 'description': '12 hour fasting levels of inflammatory markers in blood will be used as an indicator of cardiovascular health.'}, {'measure': 'Healthcare Utilization Questionnaire', 'timeFrame': '0- 24 weeks', 'description': 'An indicator of healthcare resource utilization (hospitalizations, medical appointments and investigations, medication use) for economic analysis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Community program', 'Wellness', 'Exercise', 'Physical Activity', 'Education', 'Stroke', 'Self-management'], 'conditions': ['Cerebrovascular Accident']}, 'referencesModule': {'references': [{'pmid': '29335013', 'type': 'DERIVED', 'citation': 'Richardson J, Tang A, Guyatt G, Thabane L, Xie F, Sahlas D, Hart R, Fleck R, Hladysh G, Macrae L. FIT for FUNCTION: study protocol for a randomized controlled trial. Trials. 2018 Jan 15;19(1):39. doi: 10.1186/s13063-017-2416-3.'}]}, 'descriptionModule': {'briefSummary': 'Building on an earlier pilot study, this randomized controlled trial will compare the effectiveness of a 12 week community YMCA-based wellness program specifically designed for people with stroke (Fit for Function) to a standard YMCA membership.', 'detailedDescription': 'The program will be delivered through a partnership between McMaster University, the YMCA and Hamilton Health Sciences/ the Brant Community Healthcare System/ the Niagara Health System. Participants will exercise three times a week and receive weekly education about how to take care of themselves after a stroke. The YMCA staff who deliver the program will have specialized training about how to help people with a stroke exercise safely and effectively. The hospital within each region will provide specialized on-site physiotherapy consultative support. The comparator standard YMCA membership will include typical sessions with a wellness coach who has basic safety training regarding stroke and exercise.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with stroke\n* 18 years of age or older\n* community dwelling\n* able to walk 10m independently, with or without an assistive device\n* medically approved by a physician to participate\n* able to tolerate 60 minutes of activity with rest intervals\n* able to independently follow instructions\n\nExclusion Criteria:\n\n* involved in an active rehabilitation program'}, 'identificationModule': {'nctId': 'NCT02703805', 'briefTitle': 'Fit For Function: A Community Wellness Program for Persons With Stroke', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Fit For Function: A Community Wellness Program for Persons With Stroke', 'orgStudyIdInfo': {'id': 'FFF133486'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fit For Function Program', 'description': 'A 12-week YMCA-based wellness program for persons with stroke, consisting of 2 group exercise sessions, one gym exercise session and one education session per week with trained instructors.', 'interventionNames': ['Other: Fit For Function Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard YMCA membership', 'description': 'A 12 week standard YMCA membership.', 'interventionNames': ['Other: Standard YMCA membership']}], 'interventions': [{'name': 'Fit For Function Program', 'type': 'OTHER', 'description': 'A 12-week YMCA-based wellness program for persons with stroke, consisting of 2 group exercise sessions, one gym exercise session and one education session per week with trained instructors', 'armGroupLabels': ['Fit For Function Program']}, {'name': 'Standard YMCA membership', 'type': 'OTHER', 'description': 'A 12 week standard YMCA membership.', 'armGroupLabels': ['Standard YMCA membership']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brantford', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Brantford Family YMCA', 'geoPoint': {'lat': 43.1334, 'lon': -80.26636}}, {'zip': 'L8P 2Z1', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Downtown Hamilton YMCA', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'L2N 7P9', 'city': 'St. Catharines', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Walker Family YMCA', 'geoPoint': {'lat': 43.17126, 'lon': -79.24267}}], 'overallOfficials': [{'name': 'Julie Richardson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}, {'name': 'Ada Tang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Results will be communicated to the Central South Regional Stroke Network and the Ontario Stroke System. Results will also be disseminated through professional organizations, the Ontario Ministry of Health and Long Term Care, peer reviewed conferences, provincial and national stroke forums, journal articles and special interest groups like the Stroke Recovery Group.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}, {'name': 'YMCA of Hamilton/Burlington/Brant', 'class': 'UNKNOWN'}, {'name': 'YMCA of Niagara', 'class': 'UNKNOWN'}, {'name': 'Brant Community Healthcare System', 'class': 'UNKNOWN'}, {'name': 'Niagara Health System', 'class': 'OTHER'}, {'name': 'Hamilton Health Sciences Corporation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}