Transient Ischemic AttackPhase 2PREVENTNCT00885456
Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke or Transient Ischemic Attack: A Multi-site RCT
A Phase 2 study testing PREVENT program in people with Transient Ischemic Attack and Non-disabling Stroke, run by Marilyn MacKay-Lyons at 2 sites in Canada.
Trial summary
The objective of the Program of Rehabilitative Exercise and Education to avert Vascular Events after Non-disabling stroke and Transient ischemic attack (PREVENT) Trial is to determine whether the timely delivery of secondary stroke prevention strategies will reduce modifiable vascular risk factors in two groups of… Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Transient Ischemic Attack, Non-disabling Stroke
- What is being tested?
- PREVENT program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 2 sitesCanada
- Study dates
- 30 Oct 2011to 30 Jun 2017
- Phase
- Phase 2
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Males and females
- Over 17 years of age.
- Diagnosis of first probable or definite TIA or non-disabling stroke (National Institutes of Health Stroke Scale < 6)
- Post-event interval of <90 days.
- Residence within 75 km of intervention site.
- Orientation to time, place and person and ability to follow simple 3-step commands.
- Ability and willingness to provide informed consent.
Who cannot join
- Evidence of intracranial hemorrhage on MRI or CT scan.
- Presence of contraindications to exercise testing and training, in accordance with American College of Sports Medicine Guidelines.
- Participation in another study that could potentially confound the outcomes of this trial.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Halifax Infirmary Site, QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
Annapolis Valley Regional Hospital
Kentville, Nova Scotia, B4N 5E3
About this study
Official title: Effectiveness of a Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke: A Multi-site RCT
The objective of the Program of Rehabilitative Exercise and Education to avert Vascular Events after Non-disabling stroke and Transient ischemic attack (PREVENT) Trial is to determine whether the timely delivery of secondary stroke prevention strategies will reduce modifiable vascular risk factors in two groups of people who have survived NDS or TIA. One group will receive a comprehensive education and exercise program (PREVENT); the other group will receive usual care (USUAL CARE). We will measure modifiable vascular risk factors in both groups. We will also compare the effects of PREVENT vs USUAL CARE on exercise capacity, walking endurance, and daily physical activity. In addition, we will compare thinking ability, depression, achievement of personal goals for healthy behavior, and health-related goal attainment and health-related quality of life. Finally, we will compare outcomes in urban and rural settings as well as costs of the PREVENT program and USUAL CARE in order to assess sustainability of the PREVENT program.
- Conditions
- Transient Ischemic Attack, Non-disabling Stroke
- Being tested
- PREVENT program, Usual Care
- Keywords
- stroke, secondary prevention, vascular risk, behavioral change, exercise, lifestyle modification
- Medical subject headings
- Ischemic Attack, Transient, Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREVENT programBehavioural
12-week program of aerobic/strengthening exercises and education designed to induce physiological and behavioral changes deemed necessary to reduce vascular risk
Usual CareBehavioural
Three or more out-patient visits to the neurovascular clinic for assessment, counseling and referral to appropriate health care professionals.
| Study group | Role | What they receive |
|---|---|---|
| PREVENT program | Experimental | 12-week program of exercise and education to induce physiological and behavioral changes needed to reduce vascular risk factors. Receives: Behavioral: PREVENT program |
| Usual Care | Active comparator | Average of three visits to the Neurovascular Clinic for a neurological and health assessment, counseling regarding stroke/TIA and diagnostic test results, and assessment, modification and education of secondary prevention factors Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic blood pressure (primary vascular risk factor being assessed)
Measured: baseline, post-intervention, 6 months, 12 months
diastolic blood pressure
Measured: baseline, post-intervention, 6 months, 12 months
waist circumference
Measured: baseline, post-intervention, 6 months, 12 months
12-hour fasting lipid profile
Measured: baseline, post-intervention, 6 months, 12 months
12-hour fasting glucose/hemoglobin A1C
Measured: baseline, post-intervention, 6 months, 12 months
Secondary outcomes (12)
exercise capacity
Measured: baseline, post-intervention, 12 months
daily physical activity
Measured: baseline, post-intervention, 6 months, 12 months
walking endurance
Measured: baseline, post-intervention, 6 months, 12 months
cigarette smoking
Measured: baseline, post-intervention, 6 months, 12 months
medication adherence
Measured: baseline, post-intervention, 6 months, 12 months
cognition
Measured: baseline, 12 months
depression
Measured: baseline, post-intervention, 6 months, 12 months
health-related quality of life
Measured: baseline, post-intervention, 6 months, 12 months
health-related goal attainment
Measured: baseline, post-intervention, 6 months, 12 months
direct health costs
Measured: baseline, post-intervention, 6 months, 12 months
secondary vascular events
Measured: baseline, post-intervention, 6 months, 12 months
daily step count
Measured: baseline, post-intervention, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study start30 Oct 2011
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Transient Ischemic AttackStudies 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marilyn MacKay-Lyons
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Canadian Institutes of Health Research (CIHR), Canadian Stroke Network
- Responsible party
- Sponsor-investigator, Marilyn MacKay-Lyons, Nova Scotia Health Authority
- Investigators
- Marilyn MacKay-Lyons, PhD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885456
- Sponsor's protocol ID
- PREVENT Trial
- Acronym
- PREVENT
- Status last verified
- Mar 2018
- First submitted
- 21 Apr 2009
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
MacKay-Lyons M, Gubitz G, Phillips S, Giacomantonio N, Firth W, Thompson K, Theriault C, Wightman H, Slipp S, Marsters D, Eskes G, Peacock F, Blanchard C, Dewolfe J. Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-Disabling Stroke or Transient Ischemic Attack (PREVENT Trial): A Randomized Controlled Trial. Neurorehabil Neural Repair. 2022 Feb;36(2):119-130. doi: 10.1177/15459683211060345. Epub 2021 Nov 17.
PubMed 34788569MacKay-Lyons M, Gubitz G, Giacomantonio N, Wightman H, Marsters D, Thompson K, Blanchard C, Eskes G, Thornton M. Program of rehabilitative exercise and education to avert vascular events after non-disabling stroke or transient ischemic attack (PREVENT Trial): a multi-centred, randomised controlled trial. BMC Neurol. 2010 Dec 8;10:122. doi: 10.1186/1471-2377-10-122.
PubMed 21143864
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-disabling Stroke: A Multi-site RCT
- ClinicalTrials.gov ID
- NCT00885456
- Acronym / sponsor ID
- PREVENT / PREVENT Trial
- Conditions
- Transient Ischemic Attack, Non-disabling Stroke
- Keywords
- stroke, secondary prevention, vascular risk, behavioral change, exercise, lifestyle modification
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Marilyn MacKay-LyonsUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada, Canadian Institutes of Health Research (CIHR), Canadian Stroke Network
- Study start
- 30 Oct 2011 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 22 Apr 2009 (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 the Program of Rehabilitative Exercise and Education to avert Vascular Events after Non-disabling stroke and Transient ischemic attack (PREVENT) Trial is to determine whether the timely delivery of secondary stroke prevention strategies will reduce modifiable vascular risk factors in two groups of people who have survived NDS or TIA. One group will receive a comprehensive education and exercise program (PREVENT); the other group will receive usual care (USUAL CARE). We will measure modifiable vascular risk factors in both groups. We will also compare the effects of PREVENT vs USUAL CARE on exercise capacity, walking endurance, and daily physical activity. In addition, we will compare thinking ability, depression, achievement of personal goals for healthy behavior, and health-related goal attainment and health-related quality of life. Finally, we will compare outcomes in urban and rural settings as well as costs of the PREVENT program and USUAL CARE in order to assess sustainability of the PREVENT program.
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 |
|---|---|---|
| PREVENT program | Experimental | Behavioral: PREVENT program12-week program of exercise and education to induce physiological and behavioral changes needed to reduce vascular risk factors. |
| Usual Care | Active comparator | Behavioral: Usual CareAverage of three visits to the Neurovascular Clinic for a neurological and health assessment, counseling regarding stroke/TIA and diagnostic test results, and assessment, modification and education of secondary prevention factors |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females
- Over 17 years of age.
- Diagnosis of first probable or definite TIA or non-disabling stroke (National Institutes of Health Stroke Scale < 6)
- Post-event interval of <90 days.
- Residence within 75 km of intervention site.
Key exclusion criteria (3 listed)
- Evidence of intracranial hemorrhage on MRI or CT scan.
- Presence of contraindications to exercise testing and training, in accordance with American College of Sports Medicine Guidelines.
- Participation in another study that could potentially confound the outcomes of this trial.
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 |
|---|---|---|
| PREVENT program12-week program of aerobic/strengthening exercises and education designed to induce physiological and behavioral changes deemed necessary to reduce vascular risk | Behavioural | PREVENT program |
| Usual CareThree or more out-patient visits to the neurovascular clinic for assessment, counseling and referral to appropriate health care professionals. | Behavioural | Usual Care |
Primary outcome
systolic blood pressure (primary vascular risk factor being assessed)
Time frame: baseline, post-intervention, 6 months, 12 months
diastolic blood pressure
Time frame: baseline, post-intervention, 6 months, 12 months
waist circumference
Time frame: baseline, post-intervention, 6 months, 12 months
12-hour fasting lipid profile
Time frame: baseline, post-intervention, 6 months, 12 months
12-hour fasting glucose/hemoglobin A1C
Time frame: baseline, post-intervention, 6 months, 12 months
12 secondary outcomes
exercise capacity
Time frame: baseline, post-intervention, 12 months
daily physical activity
Time frame: baseline, post-intervention, 6 months, 12 months
walking endurance
Time frame: baseline, post-intervention, 6 months, 12 months
cigarette smoking
Time frame: baseline, post-intervention, 6 months, 12 months
medication adherence
Time frame: baseline, post-intervention, 6 months, 12 months
cognition
Time frame: baseline, 12 months
depression
Time frame: baseline, post-intervention, 6 months, 12 months
health-related quality of life
Time frame: baseline, post-intervention, 6 months, 12 months
health-related goal attainment
Time frame: baseline, post-intervention, 6 months, 12 months
direct health costs
Time frame: baseline, post-intervention, 6 months, 12 months
secondary vascular events
Time frame: baseline, post-intervention, 6 months, 12 months
daily step count
Time frame: baseline, post-intervention, 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 23 Mar 2018.
- Derived from this study: PubMed 34788569MacKay-Lyons M, Gubitz G, Phillips S, Giacomantonio N, Firth W, Thompson K, Theriault C, Wightman H, Slipp S, Marsters D, Eskes G, Peacock F, Blanchard C, Dewolfe J. Program of Rehabilitative Exercise and Education to Avert Vascular Events After Non-Disabling Stroke or Transient Ischemic Attack (PREVENT Trial): A Randomized Controlled Trial. Neurorehabil Neural Repair. 2022 Feb;36(2):119-130. doi: 10.1177/15459683211060345. Epub 2021 Nov 17.
- Derived from this study: PubMed 21143864MacKay-Lyons M, Gubitz G, Giacomantonio N, Wightman H, Marsters D, Thompson K, Blanchard C, Eskes G, Thornton M. Program of rehabilitative exercise and education to avert vascular events after non-disabling stroke or transient ischemic attack (PREVENT Trial): a multi-centred, randomised controlled trial. BMC Neurol. 2010 Dec 8;10:122. doi: 10.1186/1471-2377-10-122.
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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.
Marilyn MacKay-Lyons, PhD principal investigator
Dalhousie University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PREVENT program in people with Transient Ischemic Attack and Non-disabling Stroke, run by Marilyn MacKay-Lyons 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 7 inclusion and 3 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 23 Mar 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
systolic blood pressure (primary vascular risk factor being assessed) (time frame: baseline, post-intervention, 6 months, 12 months). The study lists 5 primary outcomes in all. 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 NCT00885456, which also lists 2 linked publications.
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 23 Mar 2018.