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

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ClinicalTrials.gov Identifier: NCT01194102
Recruitment Status : Completed
First Posted : September 2, 2010
Last Update Posted : April 9, 2018
Sponsor:
Collaborators:
Hamilton Health Sciences Corporation
Ontario Stroke Network
Information provided by (Responsible Party):
McMaster University

September 1, 2010
September 2, 2010
April 9, 2018
October 2010
October 2012   (Final data collection date for primary outcome measure)
  • 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.
  • 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.
  • 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.
Same as current
Complete list of historical versions of study NCT01194102 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Fit for Function: A Community Wellness Program for Persons With Stroke
Fit for Function: A Community Wellness Program for Persons With Stroke
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Stroke
  • 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.
  • 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.
    Interventions:
    • Behavioral: Community Based Exercise Program
    • Other: Living with Stroke Education program
    • Other: YMCA membership
  • 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.
    Intervention: Other: YMCA membership
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
52
October 2012
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01194102
OSNRC-2010
No
Not Provided
Not Provided
McMaster University
McMaster University
  • Hamilton Health Sciences Corporation
  • Ontario Stroke Network
Principal Investigator: Julie Richardson, PhD McMaster University
McMaster University
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP