StrokePhase 1NCT01067495
Adapted Cardiac Rehabilitation After Stroke
A Phase 1 study testing Cardiac rehabilitation in people with Stroke, run by Toronto Rehabilitation Institute at 1 site in Canada.
Trial summary
Despite the similarities between heart disease and stroke in terms of disease process and elevated risk of recurrent events, exercise-based programs akin to cardiac rehabilitation are not available for people with stroke. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Cardiac rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2006to Dec 2009
- Phase
- Phase 1
- 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
- Chedoke-McMaster Stroke Assessment (CMSA) Scale Leg Score between 3 and 7
- At least 3 months post-stroke
- Ability to understand the process and instructions for exercise training and provide informed consent
- Ability to complete 6-minute walk test
Who cannot join
- Resting blood pressure greater than 160/100 despite medication
- Other cardiovascular morbidity which would limit exercise tolerance (heart failure, abnormal blood pressure responses or ST-segment depression > 2 mm, symptomatic aortic stenosis, complex arrhythmias)
- Unstable angina
- Orthostatic blood pressure decrease of > 20 mm Hg with symptoms
- Hypertrophic cardiomyopathy
- Other musculoskeletal impairments which would limit the participant's ability to cycle or walk
- Pain or other co-morbidities (e.g. unclipped aneurysms, uncontrolled seizures etc.) which would preclude participation
- Cognitive and/or behavioural issues that would limit participation in exercise testing and training
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Rehabilitation Institute Cardiac Rehabilitation and Secondary Prevention Program - Rumsey Centre
Toronto, Ontario, M4G 1R7
About this study
Official title: Feasibility and Effects of Cardiac Rehabilitation for Individuals After Stroke
Despite the similarities between heart disease and stroke in terms of disease process and elevated risk of recurrent events, exercise-based programs akin to cardiac rehabilitation are not available for people with stroke.
The purpose of this study is to examine 1) the feasibility of adapting cardiac rehabilitation for individuals with stroke, and 2) the effects of this program on aerobic capacity, walking, risk factors, community integration and quality of life.
The investigators anticipate that cardiac rehabilitation may be appropriately adapted to accommodate individuals with stroke who have a range of functional abilities, and that this program is effective in improving aerobic capacity, walking ability and stroke risk factors. The investigators also anticipate participants will demonstrate improved community integration and quality of life following this program.
Read the detailed description
There are many parallels between heart disease in stroke, including their cardiovascular etiologies, presence of co-morbidities and similarities in risk factors. Cardiac rehabilitation is a well-established and successful model of care for individuals with heart disease that is focused on exercise and risk factor modification. Yet analogous secondary prevention programs for the stroke program are not readily available.
The main research question is: What is the feasibility and effect of cardiac rehabilitation in individuals following stroke?
The objectives are:
- To determine if stroke survivors are able and willing to participate in a cardiac rehabilitation program. Specifically, to determine the feasibility of the cardiac rehabilitation program in individuals following stroke as determined by compliance to attendance and training requirements.
- To determine if a cardiac rehabilitation program will have a meaningful benefit, among chronic stroke survivors, on:
- walking capacity and ability: considering functional capacity [endurance / distance] and quality [neuromotor control],
- community integration: considering quantity [activity monitors] and quality [index of reintegration to normal living] of activity
- health-related quality of life: as determined by stroke specific index
- risk factors for subsequent stroke: including exercise capacity, blood pressure, blood lipid profile
- Conditions
- Stroke
- Being tested
- Cardiac rehabilitation
- Keywords
- stroke, rehabilitation, exercise, walking, risk factors
- 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.
Cardiac rehabilitationBehavioural
Participants will participate in a 6-month cardiac rehabilitation exercise program. This program will include aerobic and resistance training, and education sessions on risk factor management.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Not described Receives: Behavioral: Cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness (aerobic capacity) and walking capacity (6 minute walk test, spatiotemporal gait parameters)
Measured: Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (12 months)
Secondary outcomes (1)
Plasma lipid analysis, questionnaires pertaining to quality of life and community integration
Measured: Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startJan 2006
- Primary completionDec 2009
- Study completionDec 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Rehabilitation Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Investigators
- William E McIlroy, PhD, Principal investigator, University of WaterlooPaul Oh, MD, Principal investigator, Toronto Rehabilitation Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067495
- Sponsor's protocol ID
- HSFO-SRA5977
- Status last verified
- Feb 2010
- First submitted
- 8 Feb 2010
- Last updated
- 11 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Tang A, Marzolini S, Oh P, McIlroy WE, Brooks D. Feasibility and effects of adapted cardiac rehabilitation after stroke: a prospective trial. BMC Neurol. 2010 Jun 9;10:40. doi: 10.1186/1471-2377-10-40.
PubMed 20529376
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effects of Cardiac Rehabilitation for Individuals After Stroke
- ClinicalTrials.gov ID
- NCT01067495
- Acronym / sponsor ID
- HSFO-SRA5977
- Conditions
- Stroke
- Keywords
- stroke, rehabilitation, exercise, walking, risk factors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Toronto Rehabilitation InstituteUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Ontario
- Study start
- Jan 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 11 Feb 2010 (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.
Despite the similarities between heart disease and stroke in terms of disease process and elevated risk of recurrent events, exercise-based programs akin to cardiac rehabilitation are not available for people with stroke.
The purpose of this study is to examine 1) the feasibility of adapting cardiac rehabilitation for individuals with stroke, and 2) the effects of this program on aerobic capacity, walking, risk factors, community integration and quality of life.
The investigators anticipate that cardiac rehabilitation may be appropriately adapted to accommodate individuals with stroke who have a range of functional abilities, and that this program is effective in improving aerobic capacity, walking ability and stroke risk factors. The investigators also anticipate participants will demonstrate improved community integration and quality of life following this program.
Detailed description
There are many parallels between heart disease in stroke, including their cardiovascular etiologies, presence of co-morbidities and similarities in risk factors. Cardiac rehabilitation is a well-established and successful model of care for individuals with heart disease that is focused on exercise and risk factor modification. Yet analogous secondary prevention programs for the stroke program are not readily available.
The main research question is: What is the feasibility and effect of cardiac rehabilitation in individuals following stroke?
The objectives are:
- To determine if stroke survivors are able and willing to participate in a cardiac rehabilitation program. Specifically, to determine the feasibility of the cardiac rehabilitation program in individuals following stroke as determined by compliance to attendance and training requirements.
- To determine if a cardiac rehabilitation program will have a meaningful benefit, among chronic stroke survivors, on:
- walking capacity and ability: considering functional capacity [endurance / distance] and quality [neuromotor control],
- community integration: considering quantity [activity monitors] and quality [index of reintegration to normal living] of activity
- health-related quality of life: as determined by stroke specific index
- risk factors for subsequent stroke: including exercise capacity, blood pressure, blood lipid profile
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Cardiac rehabilitation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Chedoke-McMaster Stroke Assessment (CMSA) Scale Leg Score between 3 and 7
- At least 3 months post-stroke
- Ability to understand the process and instructions for exercise training and provide informed consent
- Ability to complete 6-minute walk test
Key exclusion criteria (8 listed)
- Resting blood pressure greater than 160/100 despite medication
- Other cardiovascular morbidity which would limit exercise tolerance (heart failure, abnormal blood pressure responses or ST-segment depression > 2 mm, symptomatic aortic stenosis, complex arrhythmias)
- Unstable angina
- Orthostatic blood pressure decrease of > 20 mm Hg with symptoms
- Hypertrophic cardiomyopathy
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 |
|---|---|---|
| Cardiac rehabilitationParticipants will participate in a 6-month cardiac rehabilitation exercise program. This program will include aerobic and resistance training, and education sessions on risk factor management. | Behavioural | Exercise |
Primary outcome
Cardiorespiratory fitness (aerobic capacity) and walking capacity (6 minute walk test, spatiotemporal gait parameters)
Time frame: Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (12 months)
1 secondary outcome
Plasma lipid analysis, questionnaires pertaining to quality of life and community integration
Time frame: Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (12 months)
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 11 Feb 2010.
- Derived from this study: PubMed 20529376Tang A, Marzolini S, Oh P, McIlroy WE, Brooks D. Feasibility and effects of adapted cardiac rehabilitation after stroke: a prospective trial. BMC Neurol. 2010 Jun 9;10:40. doi: 10.1186/1471-2377-10-40.
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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.
William E McIlroy, PhD principal investigator
University of Waterloo
Paul Oh, MD principal investigator
Toronto Rehabilitation Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cardiac rehabilitation in people with Stroke, run by Toronto Rehabilitation Institute 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 8 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 11 Feb 2010. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Cardiorespiratory fitness (aerobic capacity) and walking capacity (6 minute walk test, spatiotemporal gait parameters) (time frame: Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (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 NCT01067495, 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 11 Feb 2010.