Cerebrovascular AccidentNCT02703805
Fit For Function: A Community Wellness Program for Persons With Stroke
A study testing Fit For Function Program and Standard YMCA membership in people with Cerebrovascular Accident, run by McMaster University at 3 sites in Canada.
Trial summary
Building on an earlier pilot study, this randomized controlled trial will compare the effectiveness of a 12 week community YMCA-based wellness program specifically designed for people with stroke (Fit for Function) to a standard YMCA membership. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Fit For Function Program and Standard YMCA membership
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 3 sitesCanada
- Study dates
- May 2014to Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with stroke
- 18 years of age or older
- community dwelling
- able to walk 10m independently, with or without an assistive device
- medically approved by a physician to participate
- able to tolerate 60 minutes of activity with rest intervals
- able to independently follow instructions
Who cannot join
- involved in an active rehabilitation program
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
The Brantford Family YMCA
Brantford, Ontario
Downtown Hamilton YMCA
Hamilton, Ontario, L8P 2Z1
The Walker Family YMCA
St. Catharines, Ontario, L2N 7P9
About this study
Building on an earlier pilot study, this randomized controlled trial will compare the effectiveness of a 12 week community YMCA-based wellness program specifically designed for people with stroke (Fit for Function) to a standard YMCA membership.
Read the detailed description
The program will be delivered through a partnership between McMaster University, the YMCA and Hamilton Health Sciences/ the Brant Community Healthcare System/ the Niagara Health System. Participants will exercise three times a week and receive weekly education about how to take care of themselves after a stroke. The YMCA staff who deliver the program will have specialized training about how to help people with a stroke exercise safely and effectively. The hospital within each region will provide specialized on-site physiotherapy consultative support. The comparator standard YMCA membership will include typical sessions with a wellness coach who has basic safety training regarding stroke and exercise.
- Conditions
- Cerebrovascular Accident
- Being tested
- Fit For Function Program, Standard YMCA membership
- Keywords
- Community program, Wellness, Exercise, Physical Activity, Education, Stroke, Self-management
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit For Function ProgramOther
A 12-week YMCA-based wellness program for persons with stroke, consisting of 2 group exercise sessions, one gym exercise session and one education session per week with trained instructors
Standard YMCA membershipOther
A 12 week standard YMCA membership.
| Study group | Role | What they receive |
|---|---|---|
| Fit For Function Program | Experimental | A 12-week YMCA-based wellness program for persons with stroke, consisting of 2 group exercise sessions, one gym exercise session and one education session per week with trained instructors. Receives: Other: Fit For Function Program |
| Standard YMCA membership | Active comparator | A 12 week standard YMCA membership. Receives: Other: Standard YMCA membership |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Reintegration to Normal Living Index (RNL) from baseline
This measure assesses the degree to which individuals who have experienced traumatic or incapacitating illness achieve reintegration into normal social activities.
Measured: baseline, 12 weeks, 24 weeks
Secondary outcomes (11)
Change in The Rapid Assessment of Physical Activity (RAPA) score from baseline
This is a 9-item measure that assesses frequency and intensity of aerobic physical activity and frequency of strengthening and flexibility exercises.
Measured: baseline, 12 weeks, 24 weeks
Change in The Short Portable Performance Tests (SPPT) score from baseline
This test is used to quantify lower extremity function by evaluating the time to walk 8 feet, standing balance and repeated chair stands.
Measured: baseline, 12 weeks, 24 weeks
Change in The Six Minute Walk Test (6MWT) from baseline
This test is an indicator of exercise capacity and measures the distance walked in 6 minutes.
Measured: baseline, 12 weeks, 24 weeks
Change in Strength: Grip and Knee extension from baseline
Hand-held dynamometry will measure the average strength of three trials.
Measured: baseline, 12 weeks, 24 weeks
Change in The EQ-5D score from baseline
This is a generic utility-based health related quality of life questionnaire.
Measured: baseline, 12 weeks, 24 weeks
Change in The Patient Activation Measure (PAM) score from baseline
This is a 13-item measure of the patient's level of knowledge, skill and confidence for self-management.
Measured: baseline, 12 weeks, 24 weeks
Change in The Body Mass Index (BMI) score from baseline
The BMI will be calculated from measurements of body mass and height as an indicator of cardiovascular health.
Measured: baseline, 12 weeks, 24 weeks
Change in Blood lipid levels from baseline
12 hour fasting levels of lipids will be used as an indicator of cardiovascular health.
Measured: baseline, 12 weeks, 24 weeks
Change in blood glucose levels from baseline
12 hour fasting levels of glucose in blood will be used as an indicator of cardiovascular health.
Measured: baseline, 12 weeks, 24 weeks
Change in blood inflammatory markers from baseline
12 hour fasting levels of inflammatory markers in blood will be used as an indicator of cardiovascular health.
Measured: baseline, 12 weeks, 24 weeks
Healthcare Utilization Questionnaire
An indicator of healthcare resource utilization (hospitalizations, medical appointments and investigations, medication use) for economic analysis.
Measured: 0- 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startMay 2014
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), YMCA of Hamilton/Burlington/Brant, YMCA of Niagara, Brant Community Healthcare System, Niagara Health System, Hamilton Health Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- Julie Richardson, PhD, Principal investigator, McMaster UniversityAda Tang, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02703805
- Sponsor's protocol ID
- FFF133486
- Status last verified
- Jun 2019
- First submitted
- 14 Oct 2014
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Results will be communicated to the Central South Regional Stroke Network and the Ontario Stroke System. Results will also be disseminated through professional organizations, the Ontario Ministry of Health and Long Term Care, peer reviewed conferences, provincial and national stroke forums, journal articles and special interest groups like the Stroke Recovery Group.
Publications
Richardson J, Tang A, Guyatt G, Thabane L, Xie F, Sahlas D, Hart R, Fleck R, Hladysh G, Macrae L. FIT for FUNCTION: study protocol for a randomized controlled trial. Trials. 2018 Jan 15;19(1):39. doi: 10.1186/s13063-017-2416-3.
PubMed 29335013
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fit For Function: A Community Wellness Program for Persons With Stroke
- ClinicalTrials.gov ID
- NCT02703805
- Acronym / sponsor ID
- FFF133486
- Conditions
- Cerebrovascular Accident
- Keywords
- Community program, Wellness, Exercise, Physical Activity, Education, Stroke, Self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), YMCA of Hamilton/Burlington/Brant, YMCA of Niagara, Brant Community Healthcare System, Niagara Health System, Hamilton Health Sciences Corporation
- Study start
- May 2014 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Building on an earlier pilot study, this randomized controlled trial will compare the effectiveness of a 12 week community YMCA-based wellness program specifically designed for people with stroke (Fit for Function) to a standard YMCA membership.
Detailed description
The program will be delivered through a partnership between McMaster University, the YMCA and Hamilton Health Sciences/ the Brant Community Healthcare System/ the Niagara Health System. Participants will exercise three times a week and receive weekly education about how to take care of themselves after a stroke. The YMCA staff who deliver the program will have specialized training about how to help people with a stroke exercise safely and effectively. The hospital within each region will provide specialized on-site physiotherapy consultative support. The comparator standard YMCA membership will include typical sessions with a wellness coach who has basic safety training regarding stroke and exercise.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fit For Function Program | Experimental | Other: Fit For Function ProgramA 12-week YMCA-based wellness program for persons with stroke, consisting of 2 group exercise sessions, one gym exercise session and one education session per week with trained instructors. |
| Standard YMCA membership | Active comparator | Other: Standard YMCA membershipA 12 week standard YMCA membership. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- diagnosed with stroke
- 18 years of age or older
- community dwelling
- able to walk 10m independently, with or without an assistive device
- medically approved by a physician to participate
Key exclusion criteria (1 listed)
- involved in an active rehabilitation program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fit For Function ProgramA 12-week YMCA-based wellness program for persons with stroke, consisting of 2 group exercise sessions, one gym exercise session and one education session per week with trained instructors | Other | Fit For Function Program |
| Standard YMCA membershipA 12 week standard YMCA membership. | Other | Standard YMCA membership |
Primary outcome
Change in the Reintegration to Normal Living Index (RNL) from baseline
Time frame: baseline, 12 weeks, 24 weeks
This measure assesses the degree to which individuals who have experienced traumatic or incapacitating illness achieve reintegration into normal social activities.
11 secondary outcomes
Change in The Rapid Assessment of Physical Activity (RAPA) score from baseline
Time frame: baseline, 12 weeks, 24 weeks
Change in The Short Portable Performance Tests (SPPT) score from baseline
Time frame: baseline, 12 weeks, 24 weeks
Change in The Six Minute Walk Test (6MWT) from baseline
Time frame: baseline, 12 weeks, 24 weeks
Change in Strength: Grip and Knee extension from baseline
Time frame: baseline, 12 weeks, 24 weeks
Change in The EQ-5D score from baseline
Time frame: baseline, 12 weeks, 24 weeks
Change in The Patient Activation Measure (PAM) score from baseline
Time frame: baseline, 12 weeks, 24 weeks
Change in The Body Mass Index (BMI) score from baseline
Time frame: baseline, 12 weeks, 24 weeks
Change in Blood lipid levels from baseline
Time frame: baseline, 12 weeks, 24 weeks
Change in blood glucose levels from baseline
Time frame: baseline, 12 weeks, 24 weeks
Change in blood inflammatory markers from baseline
Time frame: baseline, 12 weeks, 24 weeks
Healthcare Utilization Questionnaire
Time frame: 0- 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Derived from this study: PubMed 29335013Richardson J, Tang A, Guyatt G, Thabane L, Xie F, Sahlas D, Hart R, Fleck R, Hladysh G, Macrae L. FIT for FUNCTION: study protocol for a randomized controlled trial. Trials. 2018 Jan 15;19(1):39. doi: 10.1186/s13063-017-2416-3.
- Individual participant dataSharing planned: Yes. Results will be communicated to the Central South Regional Stroke Network and the Ontario Stroke System. Results will also be disseminated through professional organizations, the Ontario Ministry of Health and Long Term Care, peer reviewed conferences, provincial and national stroke forums, journal articles and special interest groups like the Stroke Recovery Group.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Richardson, PhD principal investigator
McMaster University
Ada Tang, PhD principal investigator
McMaster University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fit For Function Program and Standard YMCA membership in people with Cerebrovascular Accident, run by McMaster University at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Reintegration to Normal Living Index (RNL) from baseline (time frame: baseline, 12 weeks, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02703805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2019; AzTrials last refreshed its copy on 28 Oct 2026.