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

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.

Study Overview

• Status: Completed
• Conditions: Cerebrovascular Accident
• Intervention / Treatment: Other: Fit For Function Program; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Brantford, Ontario, Canada
      • The Brantford Family YMCA
    • Hamilton, Ontario, Canada, L8P 2Z1
      • Downtown Hamilton YMCA
    • St. Catharines, Ontario, Canada, L2N 7P9
      • The Walker Family YMCA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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
Active Comparator: Standard YMCA membership; A 12 week standard YMCA membership.	Other: Standard YMCA membership; A 12 week standard YMCA membership.

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

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Canadian Institutes of Health Research (CIHR); Hamilton Health Sciences Corporation; YMCA of Hamilton/Burlington/Brant; YMCA of Niagara; Brant Community Healthcare System; Niagara Health System
• Investigators: Principal Investigator: Julie Richardson, PhD, McMaster University; Principal Investigator: Ada Tang, PhD, McMaster University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: October 14, 2014
• First Submitted That Met QC Criteria: March 3, 2016
• First Posted (Estimate): March 9, 2016

Study Record Updates

• Last Update Posted (Actual): June 26, 2019
• Last Update Submitted That Met QC Criteria: June 25, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise; Stroke; Education; Self-management; Wellness; Community program
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: FFF133486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan 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.