StrokeNCT01189045
Understanding Changes in Heart Function After Exercise in People With Stroke
A study testing Aerobic Exercise Program and Non-aerobic Exercise Program in people with Stroke, run by University of British Columbia at 2 sites in Canada.
Trial summary
Little is known about how exercise can affect heart function in stroke survivors. This study will look at changes in cardiovascular fitness and function after 6 months of exercise. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Aerobic Exercise Program and Non-aerobic Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesCanada
- Study dates
- Sep 2010to Apr 2012
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 50-80 years old
- Has experienced a stroke
- At least 12 months post-stroke
- Able to stand independently
- Able to walk at least 5 metres (assisted devices and guarded supervision is permitted)
Who cannot join
- Stroke of non-cardiogenic origin (aneurysm, tumour)
- Actively engaged in other stroke rehabilitation services
- Class C or D American Heart Association Risk Criteria (uncontrolled arrhythmias)
- Resting blood pressure > 160/100 mmHg
- Significant musculoskeletal problems (rheumatoid arthritis) or other neurological conditions (e.g. Parkinson's)
- Has a pacemaker
- Pain or other co-morbidities (e.g. unclipped aneurysms, uncontrolled seizures etc.) which would preclude participation
- Behavioural issues that would limit participation in exercise
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
GF Strong Rehabilitation Centre
Vancouver, British Columbia
Vancouver General Hospital
Vancouver, British Columbia
About this study
Official title: Beyond VO2peak: Understanding Exercise-induced Changes in Cardiovascular Function After Stroke
Little is known about how exercise can affect heart function in stroke survivors.
This study will look at changes in cardiovascular fitness and function after 6 months of exercise. Volunteers will be tested before and after the program and again 2 months later to measure the effects on stroke risk factors, fitness level and flexibility of the arteries. Blood tests will measure cholesterol levels and other signs of inflammation.
This study will help us better understand how exercise after stroke can improve heart function and heart health, and ultimately help in lowering future stroke risk.
Read the detailed description
Purpose
To determine the effects of aerobic exercise after stroke on cardiorespiratory fitness, cardiovascular function, stroke risk factors, walking and health-related quality of life. This study will also examine the retention of these effects after the exercise program ends.
Methods
A randomized controlled study design will be used. Sixty participants will be randomized to participate in one of 2 treatment arms (6 months duration, 3 days / week, 1 hour / session):
- BALANCE AND FLEXIBILITY (non-aerobic) PROGRAM will be comprised of individualized upper and lower body stretching, or balance activities, yoga- or Tai Chi-style classes.
- AEROBIC PROGRAM will be comprised of a structured, progressive aerobic training program.
Participants will be evaluated at 3 time points - baseline (0 months), post-intervention (6 months) and follow up (8 months) - for stroke risk factors, cardiorespiratory fitness, arterial stiffness, echocardiography measures, inflammatory biomarkers, ambulatory capacity and health-related quality of life.
- Conditions
- Stroke
- Being tested
- Aerobic Exercise Program, Non-aerobic Exercise Program
- Keywords
- Stroke, Exercise, Rehabilitation, 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.
Aerobic Exercise ProgramBehavioural
The AEROBIC PROGRAM will be the Experimental arm of this trial. It will be a structured, progressive aerobic training program that will be 6 months in duration. Classes will be held 3 times / week, for 1 hour / session.
Non-aerobic Exercise ProgramBehavioural
The BALANCE AND FLEXIBILITY (non-aerobic) PROGRAM will be the Active Comparator arm of this trial. It will be comprised of upper and lower body stretching, or balance activities, yoga- or Tai Chi-style classes. This program will be 6 months in duration. Classes will be held 3 times / week, for 1 hour / session.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Program | Experimental | The Aerobic Program will be the Experimental arm of this trial, where a structured, progressive aerobic exercise will be conducted in a class format Receives: Behavioral: Aerobic Exercise Program |
| Balance and Flexibility Program | Active comparator | The Balance and Flexibility Program will be a non-aerobic intervention that will act as an Active Comparator. Stretching, balance exercises, yoga- or Tai Chi-style classes will be conducted. Receives: Behavioral: Non-aerobic Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stroke risk factors (blood pressure, heart rate, lipid profiles, glucose metabolism), cardiorespiratory fitness
Measured: assessed at baseline (0 months), post-program (6 months) and follow up (8 months)
Secondary outcomes (3)
Arterial stiffness and inflammatory biomarkers
Measured: assessed at 0, 6 and 8 months
Echocardiography measures
Measured: assessed at 0 and 6 months
Ambulatory capacity and health related quality of life
Measured: assessed at 0, 6 and 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janice Eng, University of British Columbia
- Investigators
- Janice Eng, PhD, Principal investigator, The University of British Columbia - Vancouver Coastal Health Research InstitutePenelope Brasher, PhD, Study director, Vancover General HospitalAndrei Krassioukov, MD, PhD, Study director, University of British ColumbiaKenneth Madden, MD, Study director, University of British ColumbiaAda Tang, Study director, University of British ColumbiaTeresa Tsang, MD, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01189045
- Sponsor's protocol ID
- H10-00735
- Status last verified
- May 2017
- First submitted
- 24 Aug 2010
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond VO2peak: Understanding Exercise-induced Changes in Cardiovascular Function After Stroke
- ClinicalTrials.gov ID
- NCT01189045
- Acronym / sponsor ID
- H10-00735
- Conditions
- Stroke
- Keywords
- Stroke, Exercise, Rehabilitation, Risk factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 26 Aug 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.
Little is known about how exercise can affect heart function in stroke survivors.
This study will look at changes in cardiovascular fitness and function after 6 months of exercise. Volunteers will be tested before and after the program and again 2 months later to measure the effects on stroke risk factors, fitness level and flexibility of the arteries. Blood tests will measure cholesterol levels and other signs of inflammation.
This study will help us better understand how exercise after stroke can improve heart function and heart health, and ultimately help in lowering future stroke risk.
Detailed description
Purpose
To determine the effects of aerobic exercise after stroke on cardiorespiratory fitness, cardiovascular function, stroke risk factors, walking and health-related quality of life. This study will also examine the retention of these effects after the exercise program ends.
Methods
A randomized controlled study design will be used. Sixty participants will be randomized to participate in one of 2 treatment arms (6 months duration, 3 days / week, 1 hour / session):
- BALANCE AND FLEXIBILITY (non-aerobic) PROGRAM will be comprised of individualized upper and lower body stretching, or balance activities, yoga- or Tai Chi-style classes.
- AEROBIC PROGRAM will be comprised of a structured, progressive aerobic training program.
Participants will be evaluated at 3 time points - baseline (0 months), post-intervention (6 months) and follow up (8 months) - for stroke risk factors, cardiorespiratory fitness, arterial stiffness, echocardiography measures, inflammatory biomarkers, ambulatory capacity and health-related quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Program | Experimental | Behavioral: Aerobic Exercise ProgramThe Aerobic Program will be the Experimental arm of this trial, where a structured, progressive aerobic exercise will be conducted in a class format |
| Balance and Flexibility Program | Active comparator | Behavioral: Non-aerobic Exercise ProgramThe Balance and Flexibility Program will be a non-aerobic intervention that will act as an Active Comparator. Stretching, balance exercises, yoga- or Tai Chi-style classes will be conducted. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 50-80 years old
- Has experienced a stroke
- At least 12 months post-stroke
- Able to stand independently
- Able to walk at least 5 metres (assisted devices and guarded supervision is permitted)
Key exclusion criteria (8 listed)
- Stroke of non-cardiogenic origin (aneurysm, tumour)
- Actively engaged in other stroke rehabilitation services
- Class C or D American Heart Association Risk Criteria (uncontrolled arrhythmias)
- Resting blood pressure > 160/100 mmHg
- Significant musculoskeletal problems (rheumatoid arthritis) or other neurological conditions (e.g. Parkinson's)
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 |
|---|---|---|
| Aerobic Exercise ProgramThe AEROBIC PROGRAM will be the Experimental arm of this trial. It will be a structured, progressive aerobic training program that will be 6 months in duration. Classes will be held 3 times / week, for 1 hour / session. | Behavioural | Aerobic Program |
| Non-aerobic Exercise ProgramThe BALANCE AND FLEXIBILITY (non-aerobic) PROGRAM will be the Active Comparator arm of this trial. It will be comprised of upper and lower body stretching, or balance activities, yoga- or Tai Chi-style classes. This program will be 6 months in duration. Classes will be held 3 times / week, for 1 hour / session. | Behavioural | Balance and Flexibility Program |
Primary outcome
Stroke risk factors (blood pressure, heart rate, lipid profiles, glucose metabolism), cardiorespiratory fitness
Time frame: assessed at baseline (0 months), post-program (6 months) and follow up (8 months)
3 secondary outcomes
Arterial stiffness and inflammatory biomarkers
Time frame: assessed at 0, 6 and 8 months
Echocardiography measures
Time frame: assessed at 0 and 6 months
Ambulatory capacity and health related quality of life
Time frame: assessed at 0, 6 and 8 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 10 May 2017.
Related trials for Stroke
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Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke
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A Speaking-Valve-Based Decannulation Protocol for Tracheostomized Stroke Patients
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Blood Pressure Reduction to Limit the Evolution of Vascular Brain Lesions in Elderly Individuals
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Effect of Early Tendon Vibrations on Upper Limb Motor Recovery After a 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.
Janice Eng, PhD principal investigator
The University of British Columbia - Vancouver Coastal Health Research Institute
Penelope Brasher, PhD study director
Vancover General Hospital
Andrei Krassioukov, MD, PhD study director
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise Program and Non-aerobic Exercise Program in people with Stroke, run by University of British Columbia at 2 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 5 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 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Stroke risk factors (blood pressure, heart rate, lipid profiles, glucose metabolism), cardiorespiratory fitness (time frame: assessed at baseline (0 months), post-program (6 months) and follow up (8 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 May 2017.