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

Study Overview
=================
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.

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

Conditions
-----------------
Cerebrovascular Accident

Intervention / Treatment
-----------------
* Other: Fit For Function Program
* Other: Standard YMCA membership


Participation Criteria
=================
Eligibility Criteria
-----------------
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 Exclusion Criteria: involved in an active rehabilitation program

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fit For Function Program<br>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<br>* 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<br>|
| Active Comparator: Standard YMCA membership<br>A 12 week standard YMCA membership. | Other: Standard YMCA membership<br>* A 12 week standard YMCA membership.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline, 12 weeks, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | baseline, 12 weeks, 24 weeks | 
| Healthcare Utilization Questionnaire | An indicator of healthcare resource utilization (hospitalizations, medical appointments and investigations, medication use) for economic analysis. | 0- 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Community program, Wellness, Exercise, Physical Activity, Education, Stroke, Self-management