Fit For Function: A Community Wellness Program for Persons With Stroke

Not Applicable

Completed

• Conditions: Cerebrovascular Accident
• Interventions: Other: Standard YMCA membership; Other: Fit For Function Program

• Registration Number: NCT02703805
• Lead Sponsor: McMaster University

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-10-14
• Study First Submitted QC: 2016-03-03
• Study First Posted: 2016-03-09
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-25
• Last Update Posted: 2019-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

Inclusion Criteria

• diagnosed with stroke
• 18 years of age or older
• community dwelling
• able to walk 10m independently, with or without an assistive device
• medically approved by a physician to participate
• able to tolerate 60 minutes of activity with rest intervals
• able to independently follow instructions

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Exclusion Criteria

• involved in an active rehabilitation program

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard YMCA membership	Standard YMCA membership	A 12 week standard YMCA membership.
Fit For Function Program	Fit For Function Program	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.

Primary Outcome Measures

Name	Time	Method
Change in the Reintegration to Normal Living Index (RNL) from baseline	baseline, 12 weeks, 24 weeks	This measure assesses the degree to which individuals who have experienced traumatic or incapacitating illness achieve reintegration into normal social activities.

Secondary Outcome Measures

Name	Time	Method
Change in The Rapid Assessment of Physical Activity (RAPA) score from baseline	baseline, 12 weeks, 24 weeks	This is a 9-item measure that assesses frequency and intensity of aerobic physical activity and frequency of strengthening and flexibility exercises.
Change in blood glucose levels from baseline	baseline, 12 weeks, 24 weeks	12 hour fasting levels of glucose in blood will be used as an indicator of cardiovascular health.
Change in The Short Portable Performance Tests (SPPT) score from baseline	baseline, 12 weeks, 24 weeks	This test is used to quantify lower extremity function by evaluating the time to walk 8 feet, standing balance and repeated chair stands.
Change in The Six Minute Walk Test (6MWT) from baseline	baseline, 12 weeks, 24 weeks	This test is an indicator of exercise capacity and measures the distance walked in 6 minutes.
Change in Strength: Grip and Knee extension from baseline	baseline, 12 weeks, 24 weeks	Hand-held dynamometry will measure the average strength of three trials.
Change in The EQ-5D score from baseline	baseline, 12 weeks, 24 weeks	This is a generic utility-based health related quality of life questionnaire.
Change in The Patient Activation Measure (PAM) score from baseline	baseline, 12 weeks, 24 weeks	This is a 13-item measure of the patient's level of knowledge, skill and confidence for self-management.
Change in blood inflammatory markers from baseline	baseline, 12 weeks, 24 weeks	12 hour fasting levels of inflammatory markers in blood will be used as an indicator of cardiovascular health.
Change in The Body Mass Index (BMI) score from baseline	baseline, 12 weeks, 24 weeks	The BMI will be calculated from measurements of body mass and height as an indicator of cardiovascular health.
Change in Blood lipid levels from baseline	baseline, 12 weeks, 24 weeks	12 hour fasting levels of lipids will be used as an indicator of cardiovascular health.
Healthcare Utilization Questionnaire	0- 24 weeks	An indicator of healthcare resource utilization (hospitalizations, medical appointments and investigations, medication use) for economic analysis.

Trial Locations

Locations (3)

The Brantford Family YMCA; 🇨🇦 Brantford, Ontario, Canada

Downtown Hamilton YMCA; 🇨🇦 Hamilton, Ontario, Canada

The Walker Family YMCA; 🇨🇦 St. Catharines, Ontario, Canada