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

Primary Purpose

Cerebrovascular Accident

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Fit For Function Program
Standard 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 Cerebrovascular Accident focused on measuring Community program, Wellness, Exercise, Physical Activity, Education, Stroke, Self-management

Eligibility Criteria

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

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

Sites / Locations

  • The Brantford Family YMCA
  • Downtown Hamilton YMCA
  • The Walker Family YMCA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fit For Function Program

Standard YMCA membership

Arm Description

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.

A 12 week standard YMCA membership.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Change in Strength: Grip and Knee extension from baseline
Hand-held dynamometry will measure the average strength of three trials.
Change in The EQ-5D score from baseline
This is a generic utility-based health related quality of life questionnaire.
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.
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.
Change in Blood lipid levels from baseline
12 hour fasting levels of lipids will be used as an indicator of cardiovascular health.
Change in blood glucose levels from baseline
12 hour fasting levels of glucose in blood will be used as an indicator of cardiovascular health.
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.
Healthcare Utilization Questionnaire
An indicator of healthcare resource utilization (hospitalizations, medical appointments and investigations, medication use) for economic analysis.

Full Information

First Posted
October 14, 2014
Last Updated
June 25, 2019
Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR), YMCA of Hamilton/Burlington/Brant, YMCA of Niagara, Brant Community Healthcare System, Niagara Health System, Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02703805
Brief Title
Fit For Function: A Community Wellness Program for Persons With Stroke
Official Title
Fit For Function: A Community Wellness Program for Persons With Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
May 2014 (Actual)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR), YMCA of Hamilton/Burlington/Brant, YMCA of Niagara, Brant Community Healthcare System, Niagara Health System, Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident
Keywords
Community program, Wellness, Exercise, Physical Activity, Education, Stroke, 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
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fit For Function Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard YMCA membership
Arm Type
Active Comparator
Arm Description
A 12 week standard YMCA membership.
Intervention Type
Other
Intervention Name(s)
Fit For Function Program
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Standard YMCA membership
Intervention Description
A 12 week standard YMCA membership.
Primary Outcome Measure Information:
Title
Change in the Reintegration to Normal Living Index (RNL) from baseline
Description
This measure assesses the degree to which individuals who have experienced traumatic or incapacitating illness achieve reintegration into normal social activities.
Time Frame
baseline, 12 weeks, 24 weeks
Secondary Outcome Measure Information:
Title
Change in The Rapid Assessment of Physical Activity (RAPA) score from baseline
Description
This is a 9-item measure that assesses frequency and intensity of aerobic physical activity and frequency of strengthening and flexibility exercises.
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change in The Short Portable Performance Tests (SPPT) score from baseline
Description
This test is used to quantify lower extremity function by evaluating the time to walk 8 feet, standing balance and repeated chair stands.
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change in The Six Minute Walk Test (6MWT) from baseline
Description
This test is an indicator of exercise capacity and measures the distance walked in 6 minutes.
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change in Strength: Grip and Knee extension from baseline
Description
Hand-held dynamometry will measure the average strength of three trials.
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change in The EQ-5D score from baseline
Description
This is a generic utility-based health related quality of life questionnaire.
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change in The Patient Activation Measure (PAM) score from baseline
Description
This is a 13-item measure of the patient's level of knowledge, skill and confidence for self-management.
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change in The Body Mass Index (BMI) score from baseline
Description
The BMI will be calculated from measurements of body mass and height as an indicator of cardiovascular health.
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change in Blood lipid levels from baseline
Description
12 hour fasting levels of lipids will be used as an indicator of cardiovascular health.
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change in blood glucose levels from baseline
Description
12 hour fasting levels of glucose in blood will be used as an indicator of cardiovascular health.
Time Frame
baseline, 12 weeks, 24 weeks
Title
Change in blood inflammatory markers from baseline
Description
12 hour fasting levels of inflammatory markers in blood will be used as an indicator of cardiovascular health.
Time Frame
baseline, 12 weeks, 24 weeks
Title
Healthcare Utilization Questionnaire
Description
An indicator of healthcare resource utilization (hospitalizations, medical appointments and investigations, medication use) for economic analysis.
Time Frame
0- 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Richardson, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ada Tang, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Brantford Family YMCA
City
Brantford
State/Province
Ontario
Country
Canada
Facility Name
Downtown Hamilton YMCA
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8P 2Z1
Country
Canada
Facility Name
The Walker Family YMCA
City
St. Catharines
State/Province
Ontario
ZIP/Postal Code
L2N 7P9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
29335013
Citation
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.
Results Reference
derived

Learn more about this trial

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

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