Fit for Function: A Community Wellness Program for Persons With Stroke (FFF)

April 5, 2018 updated by: McMaster University
The purpose of this study is to evaluate whether persons with stroke participating in a 12-week community based wellness program for persons who have had a stroke, experience improved mobility (6 Minute Walk Test), balance, (The Short Portable Performance Test and Timed Up and Go), strength (JAMAR hand grip dynamometry), level of physical activity (Rapid Assessment of Physical Activity), reintegration in community (Reintegration into Normal Living Index), self efficacy (Patient Activation Measure) and Quality of Life (Stroke Specific Quality of Life Scale) compared to persons who do not participate in the program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The program will be delivered through a partnership between Hamilton Health Sciences, the YMCA and McMaster University. Participants will attend the YMCA for exercise sessions several times a week and receive education on how to take care of themselves after a stroke. The staff who will deliver the program will have specialized training on how to help people with stroke to exercise safely and effectively. Control group participants will be provided with YMCA memberships but will not have access to stroke specific education and group exercise classes.

Staff assisting the control group will be trained in safety and contraindications after stroke, but will not receive the additional specialized training in exercise/education programs for persons with stroke.

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L9B1C2
        • Les Chater Family YMCA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • adults ≥18years
  • living in the community
  • able to ambulate ≥10 meters with or without an assistive device
  • able to tolerate 60 minutes activity with rest intervals
  • have clearance from a physician to participate in the program
  • can independently follow instructions
  • are not involved in active rehabilitation

Exclusion Criteria:

  • musculoskeletal contraindications to exercise
  • unstable cardiovascular conditions
  • unstable medical conditions
  • significant cognitive impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stroke Community Wellness Program
Participants with stroke will attend a 12 week Community Wellness Program. The program consists of a Community Based Exercise Program at the YMCA (2x 1 hour exercise sessions per week with specially trained fitness instructors). They will also attend a 1 hour long "Living with Stroke" education session one time per week and an independent exercise session in the fitness centre one time per week.
Behavioral: Community Based Exercise Program
Three supervised exercise sessions per week, including individual and group sessions aimed at strengthening, flexibility and cardiovascular exercise.
Other: Living with Stroke Education program
Weekly 1 hour long education sessions on living with stroke, aimed at helping participants take better care of their health after a stroke.
Other: YMCA membership
Participants have access to YMCA facilities along with up to 7 individual sessions with a fitness trainer.
Active Comparator: Regular YMCA membership
The control group will have access to YMCA facilities to use at their discretion but will not attend the Community Based Exercise Program for stroke survivors or the "Living with Stroke" education program. YMCA staff working with the control group will not receive specialized training in exercise and education for stroke survivors but will be trained on important safety precautions and contraindications to exercise after stroke.
Other: YMCA membership
Participants have access to YMCA facilities along with up to 7 individual sessions with a fitness trainer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six minute Walk Test (6MWT)
Time Frame: baseline, 12 weeks and 24 weeks
The 6MWT is a test of exercise capacity that is measured as the distance walked in 6 minutes. Participants are instructed to cover as much ground as possible in 6 minutes. A greater distance walked indicates a better performance. The unit of measurement is metres.
baseline, 12 weeks and 24 weeks
Hand Grip Strength
Time Frame: baseline, 12 weeks, 24 weeks
Hand grip strength (average of 3 trials with either hand) will be measured using a JAMAR hand-held dynamometer. Handgrip has been shown to correlate with elbow flexion strength, knee flexion strength and trunk extension strength. The unit of measurement is kilograms. Higher numbers indicate greater grip strength.
baseline, 12 weeks, 24 weeks
Rapid Assessment of Physical Activity (RAPA)
Time Frame: baseline, 12 weeks, 24 weeks
The RAPA measures an individuals Level of Physical Activity. The RAPA is a 9 item measure that assesses frequency and intensity of aerobic physical activity and frequency of strengthening and flexibility exercises. The unit of measurement is numbers on a scale. Higher scores indicate greater levels of physical activity.
baseline, 12 weeks, 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Activation Measure (PAM)
Time Frame: baseline, 12 weeks, 24 weeks
The PAM is a 13-item measure of the patient's level of knowledge, skill and confidence for self-management of their chronic condition. The unit of measurement is numbers on a scale. Scores range from 0-100 with higher scores indicating a higher level of activation.
baseline, 12 weeks, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Hamilton Health Sciences Corporation
Ontario Stroke Network

Investigators

  • Principal Investigator: Julie Richardson, PhD, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

September 1, 2010

First Submitted That Met QC Criteria

September 1, 2010

First Posted (Estimate)

September 2, 2010

Study Record Updates

Last Update Posted (Actual)

April 9, 2018

Last Update Submitted That Met QC Criteria

April 5, 2018

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSNRC-2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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