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

Stroke Clinical Trial

— FFF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01194102
• Other study ID #: OSNRC-2010
• Status: Completed
• Phase: N/A
• First received: September 1, 2010
• Last updated: April 5, 2018
• Start date: October 2010
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Canada	Les Chater Family YMCA	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Hamilton Health Sciences Corporation, Ontario Stroke Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline, 12 weeks and 24 weeks
Primary	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.	baseline, 12 weeks, 24 weeks
Primary	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.	baseline, 12 weeks, 24 weeks
Secondary	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.	baseline, 12 weeks, 24 weeks