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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Community Based Exercise Program
Living with Stroke Education program
YMCA membership
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring Stroke, Exercise, Physical function, Community program, Patient education, Self-management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Les Chater Family YMCA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stroke Community Wellness Program

Regular YMCA membership

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Six minute Walk Test (6MWT)
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.
Hand Grip Strength
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.
Rapid Assessment of Physical Activity (RAPA)
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.

Secondary Outcome Measures

Patient Activation Measure (PAM)
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.

Full Information

First Posted
September 1, 2010
Last Updated
April 5, 2018
Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation, Ontario Stroke Network
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1. Study Identification

Unique Protocol Identification Number
NCT01194102
Brief Title
Fit for Function: A Community Wellness Program for Persons With Stroke
Acronym
FFF
Official Title
Fit for Function: A Community Wellness Program for Persons With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Hamilton Health Sciences Corporation, Ontario Stroke Network

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Exercise, Physical function, Community program, Patient education, Self-management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stroke Community Wellness Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Regular YMCA membership
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Community Based Exercise Program
Intervention Description
Three supervised exercise sessions per week, including individual and group sessions aimed at strengthening, flexibility and cardiovascular exercise.
Intervention Type
Other
Intervention Name(s)
Living with Stroke Education program
Intervention Description
Weekly 1 hour long education sessions on living with stroke, aimed at helping participants take better care of their health after a stroke.
Intervention Type
Other
Intervention Name(s)
YMCA membership
Intervention Description
Participants have access to YMCA facilities along with up to 7 individual sessions with a fitness trainer.
Primary Outcome Measure Information:
Title
Six minute Walk Test (6MWT)
Description
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.
Time Frame
baseline, 12 weeks and 24 weeks
Title
Hand Grip Strength
Description
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.
Time Frame
baseline, 12 weeks, 24 weeks
Title
Rapid Assessment of Physical Activity (RAPA)
Description
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.
Time Frame
baseline, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Patient Activation Measure (PAM)
Description
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.
Time Frame
baseline, 12 weeks, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Richardson, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Les Chater Family YMCA
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L9B1C2
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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