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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02703805
Enrollment
218
Registered
2016-03-09
Start date
2014-05-31
Completion date
2018-11-30
Last updated
2019-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Accident

Keywords

Community program, Wellness, Exercise, Physical Activity, Education, Stroke, Self-management

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.

Interventions

OTHERFit 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

OTHERStandard YMCA membership

A 12 week standard YMCA membership.

Sponsors

Canadian Institutes of Health Research (CIHR)
CollaboratorOTHER_GOV
YMCA of Hamilton/Burlington/Brant
CollaboratorUNKNOWN
YMCA of Niagara
CollaboratorUNKNOWN
Brant Community Healthcare System
CollaboratorUNKNOWN
Niagara Health System
CollaboratorOTHER
Hamilton Health Sciences Corporation
CollaboratorOTHER
McMaster University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in the Reintegration to Normal Living Index (RNL) from baselinebaseline, 12 weeks, 24 weeksThis measure assesses the degree to which individuals who have experienced traumatic or incapacitating illness achieve reintegration into normal social activities.

Secondary

MeasureTime frameDescription
Change in The Short Portable Performance Tests (SPPT) score from baselinebaseline, 12 weeks, 24 weeksThis 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 baselinebaseline, 12 weeks, 24 weeksThis test is an indicator of exercise capacity and measures the distance walked in 6 minutes.
Change in Strength: Grip and Knee extension from baselinebaseline, 12 weeks, 24 weeksHand-held dynamometry will measure the average strength of three trials.
Change in The EQ-5D score from baselinebaseline, 12 weeks, 24 weeksThis is a generic utility-based health related quality of life questionnaire.
Change in The Patient Activation Measure (PAM) score from baselinebaseline, 12 weeks, 24 weeksThis is a 13-item measure of the patient's level of knowledge, skill and confidence for self-management.
Change in The Rapid Assessment of Physical Activity (RAPA) score from baselinebaseline, 12 weeks, 24 weeksThis is a 9-item measure that assesses frequency and intensity of aerobic physical activity and frequency of strengthening and flexibility exercises.
Change in Blood lipid levels from baselinebaseline, 12 weeks, 24 weeks12 hour fasting levels of lipids will be used as an indicator of cardiovascular health.
Change in blood glucose levels from baselinebaseline, 12 weeks, 24 weeks12 hour fasting levels of glucose in blood will be used as an indicator of cardiovascular health.
Change in blood inflammatory markers from baselinebaseline, 12 weeks, 24 weeks12 hour fasting levels of inflammatory markers in blood will be used as an indicator of cardiovascular health.
Healthcare Utilization Questionnaire0- 24 weeksAn indicator of healthcare resource utilization (hospitalizations, medical appointments and investigations, medication use) for economic analysis.
Change in The Body Mass Index (BMI) score from baselinebaseline, 12 weeks, 24 weeksThe BMI will be calculated from measurements of body mass and height as an indicator of cardiovascular health.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026