StrokeFITSNCT00786045
Fitness Intervention Trial for Stroke
A study testing Home Cycling Program in people with Stroke, run by McGill University at 1 site in Canada.
Trial summary
The objective of this study is to evaluate, among persons who have completed the restorative phase of stroke and have ceased rehabilitation, the relative effectiveness in improving functional exercise capacity of two programs for continued care, a home-based general fitness training program using stationary cycling… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Home Cycling Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2002to Nov 2009
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- verified stroke requiring hospital admission (based on clinical and radiological evidence)
- ability to walk a minimum of 10 meters independently, using an aid or orthotic, with or without supervision,
- less than one year since the last cerebrovascular event at the time of recruitment,
- discharge from active rehabilitation (usually around 3 to 4 months post-stroke but not less than 1 month) into the geographic study area of greater Montreal and greater Halifax.
Who cannot join
- severe cognitive deficits as evaluated by the Telephone Version of the Mini-Mental State Examination such that the subject does not understand their participation in the study,
- receptive aphasia as evaluated by the Canadian Neurological Scale48 or the treating speech therapist,
- illness or disability precluding participation in either rehabilitation intervention.
- failure to pass a standard cardiology orientated history and physical examination complemented by a baseline screening exercise stress test
Trial locations and contacts
1 site in 1 country.
Canada1 site
McGill University-Royal Victoria Hospital Site
Montreal, Quebec, H3A-1A1
About this study
Official title: Fitness Intervention Tiral for Stroke: Enhancing Walking Endurance Using Home Rehabilitation Programs
The objective of this study is to evaluate, among persons who have completed the restorative phase of stroke and have ceased rehabilitation, the relative effectiveness in improving functional exercise capacity of two programs for continued care, a home-based general fitness training program using stationary cycling and a disability targeted, home-based exercise program to enhance mobility and walking competency. capacity compared with the "walking" group and that consequently the cycle group will achieve a higher quality of life.
A secondary objective is to explore factors associated with compliance with the exercise regimens. Previous research has indicated that cognitive-affective-behavioural profile is related to exercise activity in a number of populations including sedentary adults, older adults and patients with cardiovascular disease. As we anticipate that one of the mechanisms by which the cycling will result in an outcome better than the more traditional type of disability tailored exercise program is through greater compliance, this second objective is very relevant. This study will also address the impact of regular exercise on cardio-vascular risk factor profile.
Read the detailed description
The specific clinical hypothesis to be tested is that, over a one year period, persons assigned to the general fitness "cycle" group will experience a greater increase in functional exercise
- Conditions
- Stroke
- Being tested
- Home Cycling Program
- Keywords
- stroke, rehabilitation, walking
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home Cycling ProgramOther
Participants will be given a time and intensity graded program at an intensity that is comfortable and tolerable for the individual. The individual will be encouraged to augment, gradually, either the time of cycling per day or the work of cycling, always keeping within the limits of comfort and tolerability. Participants will also be given a target heart rate threshold to try and meet but not to exceed. This will be based their response to the stress test and will most likely be between 50% and 70% of maximum age-predicted heart rate. The aim is to build up to one-half hour of cycling per day. All bicycles will be equipped with electronic monitoring of speed, distance, and heart rate.
| Study group | Role | What they receive |
|---|---|---|
| Home Cycling Program | Experimental | Participants will be given a time and intensity graded program at an intensity that is comfortable and tolerable for the individual. The individual will be encouraged to augment, gradually, either the time of cycling per day or the work of cycling, always keeping within the limits of comfort and tolerability. Participants will also be given a target heart rate threshold to try and meet but not to exceed. This will be based their response to the stress test and will most likely be between 50% and 70% of maximum age-predicted heart rate. The aim is to build up to one-half hour of cycling per day. All bicycles will be equipped with electronic monitoring of speed, distance, and heart rate. Receives: Other: Home Cycling Program |
| Control | No intervention | The investigators have devised a series of mobility-related tasks that can be easily and safely carried out at home without ongoing professional supervision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Walking Capacity (6 Minute (walk test)
Measured: baseline, 1 month, 6 months, 12 months
Secondary outcomes (1)
Quality of Life (SF-36)
Measured: Baseline, 1 month, 6 month, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2008 (estimated)
- Study startNov 2002
- Primary completionNov 2009
- Study completionNov 2009
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 StrokeStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Nancy Mayo, McGill University
- Investigators
- Nancy E Mayo, PhD, Principal investigator, McGill University, Division of Clinical Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786045
- Sponsor's protocol ID
- A11-M107-02A
- Other IDs
- MCT_66794
- Acronym
- FITS
- Status last verified
- Apr 2013
- First submitted
- 4 Nov 2008
- Last updated
- 29 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Mayo NE, MacKay-Lyons MJ, Scott SC, Moriello C, Brophy J. A randomized trial of two home-based exercise programmes to improve functional walking post-stroke. Clin Rehabil. 2013 Jul;27(7):659-71. doi: 10.1177/0269215513476312. Epub 2013 Mar 15.
PubMed 23503738
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fitness Intervention Tiral for Stroke: Enhancing Walking Endurance Using Home Rehabilitation Programs
- ClinicalTrials.gov ID
- NCT00786045
- Acronym / sponsor ID
- FITS / A11-M107-02A
- Conditions
- Stroke
- Keywords
- stroke, rehabilitation, walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Nov 2002
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 5 Nov 2008 (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.
The objective of this study is to evaluate, among persons who have completed the restorative phase of stroke and have ceased rehabilitation, the relative effectiveness in improving functional exercise capacity of two programs for continued care, a home-based general fitness training program using stationary cycling and a disability targeted, home-based exercise program to enhance mobility and walking competency. capacity compared with the "walking" group and that consequently the cycle group will achieve a higher quality of life.
A secondary objective is to explore factors associated with compliance with the exercise regimens. Previous research has indicated that cognitive-affective-behavioural profile is related to exercise activity in a number of populations including sedentary adults, older adults and patients with cardiovascular disease. As we anticipate that one of the mechanisms by which the cycling will result in an outcome better than the more traditional type of disability tailored exercise program is through greater compliance, this second objective is very relevant. This study will also address the impact of regular exercise on cardio-vascular risk factor profile.
Detailed description
The specific clinical hypothesis to be tested is that, over a one year period, persons assigned to the general fitness "cycle" group will experience a greater increase in functional exercise
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Cycling Program | Experimental | Other: Home Cycling ProgramParticipants will be given a time and intensity graded program at an intensity that is comfortable and tolerable for the individual. The individual will be encouraged to augment, gradually, either the time of cycling per day or the work of cycling, always keeping within the limits of comfort and tolerability. Participants will also be given a target heart rate threshold to try and meet but not to exceed. This will be based their response to the stress test and will most likely be between 50% and 70% of maximum age-predicted heart rate. The aim is to build up to one-half hour of cycling per day. All bicycles will be equipped with electronic monitoring of speed, distance, and heart rate. |
| Control | No intervention | –The investigators have devised a series of mobility-related tasks that can be easily and safely carried out at home without ongoing professional supervision |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- verified stroke requiring hospital admission (based on clinical and radiological evidence)
- ability to walk a minimum of 10 meters independently, using an aid or orthotic, with or without supervision,
- less than one year since the last cerebrovascular event at the time of recruitment,
- discharge from active rehabilitation (usually around 3 to 4 months post-stroke but not less than 1 month) into the geographic study area of greater Montreal and greater Halifax.
Key exclusion criteria (4 listed)
- severe cognitive deficits as evaluated by the Telephone Version of the Mini-Mental State Examination such that the subject does not understand their participation in the study,
- receptive aphasia as evaluated by the Canadian Neurological Scale48 or the treating speech therapist,
- illness or disability precluding participation in either rehabilitation intervention.
- failure to pass a standard cardiology orientated history and physical examination complemented by a baseline screening exercise stress test
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 |
|---|---|---|
| Home Cycling ProgramParticipants will be given a time and intensity graded program at an intensity that is comfortable and tolerable for the individual. The individual will be encouraged to augment, gradually, either the time of cycling per day or the work of cycling, always keeping within the limits of comfort and tolerability. Participants will also be given a target heart rate threshold to try and meet but not to exceed. This will be based their response to the stress test and will most likely be between 50% and 70% of maximum age-predicted heart rate. The aim is to build up to one-half hour of cycling per day. All bicycles will be equipped with electronic monitoring of speed, distance, and heart rate. | Other | Home Cycling Program |
Primary outcome
Functional Walking Capacity (6 Minute (walk test)
Time frame: baseline, 1 month, 6 months, 12 months
1 secondary outcome
Quality of Life (SF-36)
Time frame: Baseline, 1 month, 6 month, 12 month
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 29 Apr 2013.
- Derived from this study: PubMed 23503738Mayo NE, MacKay-Lyons MJ, Scott SC, Moriello C, Brophy J. A randomized trial of two home-based exercise programmes to improve functional walking post-stroke. Clin Rehabil. 2013 Jul;27(7):659-71. doi: 10.1177/0269215513476312. Epub 2013 Mar 15.
Related trials for Stroke
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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.
Nancy E Mayo, PhD principal investigator
McGill University, Division of Clinical Epidemiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home Cycling Program in people with Stroke, run by McGill University at 1 site 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 4 inclusion and 4 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 29 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Functional Walking Capacity (6 Minute (walk test) (time frame: baseline, 1 month, 6 months, 12 months). 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 NCT00786045, 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 29 Apr 2013.