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Completed

NCT Number: NCT01194102

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.

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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Motor Activity Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Les Chater Family YMCA

Hamilton, Ontario, L9B1C2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Community Based Exercise Program

Behavioral

Three supervised exercise sessions per week, including individual and group sessions aimed at strengthening, flexibility and cardiovascular exercise.

Living with Stroke Education program

Other

Weekly 1 hour long education sessions on living with stroke, aimed at helping participants take better care of their health after a stroke.

YMCA membership

Other

Participants have access to YMCA facilities along with up to 7 individual sessions with a fitness trainer.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Hamilton Health Sciences Corporation
  • Ontario Stroke Network

Registry information

Acronym: FFF

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 2, 2010
Registry last updated
Apr 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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