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

NCT01194102 | Completed

• 1 other identifier: OSNRC-2010
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Stroke; Exercise; Physical function; Community program; Patient education; Self-management

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (1)

• Patient Activation Measure (PAM)

  baseline, 12 weeks, 24 weeks

Study Arms (2)

Stroke Community Wellness Program

EXPERIMENTAL

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; Other: Living with Stroke Education program; Other: YMCA membership

Regular YMCA membership

ACTIVE COMPARATOR

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

Interventions

Community Based Exercise Program BEHAVIORAL

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

Stroke Community Wellness Program

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.

Stroke Community Wellness Program

YMCA membership OTHER

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

Regular YMCA membership; Stroke Community Wellness Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• musculoskeletal contraindications to exercise
• unstable cardiovascular conditions
• unstable medical conditions
• significant cognitive impairment

Sponsors & Collaborators

• McMaster University: lead
• Hamilton Health Sciences Corporation: collaborator
• Ontario Stroke Network: collaborator

Study Sites (1)

Les Chater Family YMCA

Hamilton, Ontario, L9B1C2, Canada

Location

MeSH Terms

Conditions

Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Julie Richardson, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2010
• First Posted: September 2, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 9, 2018

Record last verified: 2012-10

Locations

CA (1)