An interventional study of Fit For Function Program and Standard YMCA membership in Cerebrovascular Accident, sponsored by McMaster University. Completed at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-26.
Sponsored by McMaster University · Not applicable, Interventional, and Health services research
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.
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.
7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 218 is above the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →McMaster University is the lead sponsor of 738 studies on the registry; 125 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: Fit For Function Program
A 12 week standard YMCA membership.
Other: Standard YMCA membership
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
A 12 week standard YMCA membership.
Change in the Reintegration to Normal Living Index (RNL) from baseline
This measure assesses the degree to which individuals who have experienced traumatic or incapacitating illness achieve reintegration into normal social activities.
Time frame: baseline, 12 weeks, 24 weeks
Change in The Rapid Assessment of Physical Activity (RAPA) score from baseline
This is a 9-item measure that assesses frequency and intensity of aerobic physical activity and frequency of strengthening and flexibility exercises.
Time frame: baseline, 12 weeks, 24 weeks
Change in The Short Portable Performance Tests (SPPT) score from baseline
This test is used to quantify lower extremity function by evaluating the time to walk 8 feet, standing balance and repeated chair stands.
Time frame: baseline, 12 weeks, 24 weeks
Change in The Six Minute Walk Test (6MWT) from baseline
This test is an indicator of exercise capacity and measures the distance walked in 6 minutes.
Time frame: baseline, 12 weeks, 24 weeks
Change in Strength: Grip and Knee extension from baseline
Hand-held dynamometry will measure the average strength of three trials.
Time frame: baseline, 12 weeks, 24 weeks
Change in The EQ-5D score from baseline
This is a generic utility-based health related quality of life questionnaire.
Time frame: baseline, 12 weeks, 24 weeks
Change in The Patient Activation Measure (PAM) score from baseline
This is a 13-item measure of the patient's level of knowledge, skill and confidence for self-management.
Time frame: baseline, 12 weeks, 24 weeks
Change in The Body Mass Index (BMI) score from baseline
The BMI will be calculated from measurements of body mass and height as an indicator of cardiovascular health.
Time frame: baseline, 12 weeks, 24 weeks
Change in Blood lipid levels from baseline
12 hour fasting levels of lipids will be used as an indicator of cardiovascular health.
Time frame: baseline, 12 weeks, 24 weeks
Change in blood glucose levels from baseline
12 hour fasting levels of glucose in blood will be used as an indicator of cardiovascular health.
Time frame: baseline, 12 weeks, 24 weeks
Change in blood inflammatory markers from baseline
12 hour fasting levels of inflammatory markers in blood will be used as an indicator of cardiovascular health.
Time frame: baseline, 12 weeks, 24 weeks
Healthcare Utilization Questionnaire
An indicator of healthcare resource utilization (hospitalizations, medical appointments and investigations, medication use) for economic analysis.
Time frame: 0- 24 weeks
Plan to share: Yes — 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.
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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