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

This study has been completed.
Sponsor:
Collaborators:
Hamilton Health Sciences Corporation
Ontario Stroke Network
Information provided by (Responsible Party):
Julie Richardson, McMaster University
ClinicalTrials.gov Identifier:
NCT01194102
First received: September 1, 2010
Last updated: October 16, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Stroke
 Behavioral: Community Based Exercise Program
Other: Living with Stroke Education program
Other: YMCA membership

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Fit for Function: A Community Wellness Program for Persons With Stroke

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Six minute Walk Test (6MWT) [ Time Frame: baseline, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline, 12 weeks, 24 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 61
Study Start Date: October 2010
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194102

Locations
Canada, Ontario
Les Chater Family YMCA
Hamilton, Ontario, Canada, L9B1C2
Sponsors and Collaborators
McMaster University
Hamilton Health Sciences Corporation
Ontario Stroke Network
Investigators
Principal Investigator: Julie Richardson, PhD McMaster University
  More Information

No publications provided

Responsible Party: Julie Richardson, Dr. Julie Richardson, McMaster University
ClinicalTrials.gov Identifier: NCT01194102     History of Changes
Other Study ID Numbers: OSNRC-2010
Study First Received: September 1, 2010
Last Updated: October 16, 2012
Health Authority: Canada: Ministry of Health & Long Term Care, Ontario
Canada: Ethics Review Committee

Keywords provided by McMaster University:
Stroke
Exercise
Physical function
 Community program
Patient education
Self-management

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on June 13, 2013