Transient Ischemic AttackNCT00929994

Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack

An observational study of Transient Ischemic Attack, run by Toronto Rehabilitation Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

It is hypothesized that the addition of formal cardiac rehabilitation to standard care will result in long-term improvements in cardiovascular fitness and functional capacity in individuals who have suffered a transient ischemic attack (TIA) or minor stroke. Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Transient Ischemic Attack
What is being tested?: Cardiac Rehabilitation
Type of treatment: Lifestyle or therapy programme
How many people: 20 participants
Where: 1 siteCanada
Study dates: Mar 2010to Nov 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: TIA

Who may be able to join

Diagnosed with TIA
Three months post-TIA
Ability to understand the process and instructions for exercise training and provide informed consent

Who cannot join

Resting Blood Pressure greater than 160/100 despite medication
Other cardiovascular morbidity which would limit exercise tolerance (heart failure, abnormal BP responses or STsegment depression > 2 mm, symptomatic aortic stenosis, complex arrhythmias)
Current and extensive exercise participation
Hypertrophic Cardiomyopathy
Unstable Angina
Orthostatic BP decrease of > 20 mm Hg with symptoms

Show all 9Show fewer

Other musculoskeletal impairments which would limit the participants ability to walk sufficient durations
Pain or other co-morbidities (e.g., unclipped aneurysms, uncontrolled seizures etc.) which would preclude participation
Cognitive 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 - Rumsey Center
Toronto, Ontario, M4G 1R7

Other trials in Canada

About this study

Furthermore, it is proposed that the addition of cardiac rehabilitation will influence depressive symptoms and cognition.

Read the detailed description

A transient ischemic attack (TIA) is defined as an episode of neurological dysfunction caused by focal brain ischemia lasting less than 24 hours. Once an individual has suffered a TIA, preventative measures can be taken to target modifiable risk factors, one of which is physical inactivity. The current proposal focuses on the use of an established model of care (cardiac rehabilitation (CR)) and applies it to those who have suffered a TIA in order to maximize physical activity and minimize risk of future cardiovascular events. This will be a one-group pre/post design study with a 3 month non-intervention period. Participants will undergo measures at baseline and 3 months (non intervention period) then after 6 months of cardiac rehabilitation (cardiovascular fitness, 6 minute walk test, cognition, and depressive symptoms).

Conditions: Transient Ischemic Attack
Being tested: Cardiac Rehabilitation
Keywords: cardiac rehab
Medical subject headings: Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cardiac RehabilitationBehavioural
Individualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.

Study groups in NCT00929994
Study group	Role	What they receive
Exercise		Following a 3 month non intervention period, participants will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training. Receives: Behavioral: Cardiac Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

Functional Walk Test
6 minute walk test: the longest distance a person can walk for a duration of 6 minutes
Measured: Baseline, 3 months, 6 months (Six Minute Walk Distance)
Cardiovascular Fitness (VO2peak)
To measure cardiovascular fitness, a stress test on either an upright cycle ergometer (Ergoselect 200P, Germany), or a treadmill (same modality pre- and post-training) was performed depending on patient balance and comfort.
Measured: Baseline (after the 3 month non-intervention period) and after 6 months of participation.

Secondary outcomes (2)

Center for Epidemiologic Studies Depression Scale (CES-D).
Depressive symptoms using the validated Center for Epidemiologic Studies Depression Scale (CES-D). This is a score from a 20 item questionnaire with minimum value of 0 and maximum value of 60 with higher numbers indicated greater depressive symptoms (worse).
Measured: Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation
Cognition
Montreal Cognitive Assessment. The MoCA score ranges from 0 to 30 points with a higher score indicating better cognitive function.
Measured: Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Nov 2014

First posted30 Jun 2009 (estimated)
Study startMar 2010
Primary completionNov 2014
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00929994
Sponsor's protocol ID: Brooks - 001
Status last verified: Apr 2019
First submitted: 29 Jun 2009
Last updated: 23 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Upfront Lipid-Lowering Therapy With Statins Combined With Hybutimibe in Patients With Acute Ischemic Stroke or Transient Ischemic Attack.
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All Transient Ischemic Attack trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Cardiac Rehabilitation for Individuals With Transient Ischemic Attack
ClinicalTrials.gov ID: NCT00929994
Acronym / sponsor ID: Brooks - 001
Conditions: Transient Ischemic Attack
Keywords: cardiac rehab
Study type: Observational
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Toronto Rehabilitation InstituteUniversity, hospital or other
Collaborators: Heart and Stroke Foundation of Canada
Study start: Mar 2010
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 30 Jun 2009 (estimated)
Results: Posted 23 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Furthermore, it is proposed that the addition of cardiac rehabilitation will influence depressive symptoms and cognition.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Exercise	–	Behavioral: Cardiac RehabilitationFollowing a 3 month non intervention period, participants will participate in Cardiac Rehabilitation, carrying out an exercise program which will last 6 months and combine both resistance and aerobic training.

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: TIA

Key inclusion criteria (3 listed)

Diagnosed with TIA
Three months post-TIA
Ability to understand the process and instructions for exercise training and provide informed consent

Key exclusion criteria (9 listed)

Resting Blood Pressure greater than 160/100 despite medication
Other cardiovascular morbidity which would limit exercise tolerance (heart failure, abnormal BP responses or STsegment depression > 2 mm, symptomatic aortic stenosis, complex arrhythmias)
Current and extensive exercise participation
Hypertrophic Cardiomyopathy
Unstable Angina

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 RehabilitationIndividualized cardiac rehabilitation for 6 months, including health education sessions, as well as supervised exercise classes which include aerobic and resistance training.	Behavioural	Exercise

Primary outcome

Functional Walk Test
Time frame: Baseline, 3 months, 6 months (Six Minute Walk Distance)
6 minute walk test: the longest distance a person can walk for a duration of 6 minutes
Cardiovascular Fitness (VO2peak)
Time frame: Baseline (after the 3 month non-intervention period) and after 6 months of participation.
To measure cardiovascular fitness, a stress test on either an upright cycle ergometer (Ergoselect 200P, Germany), or a treadmill (same modality pre- and post-training) was performed depending on patient balance and comfort.

2 secondary outcomes

Center for Epidemiologic Studies Depression Scale (CES-D).
Time frame: Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation
Cognition
Time frame: Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation

Results and safety

Results posted to the registry on 23 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exercise	20	14

Primary outcome: Functional Walk Test

Time frame: Baseline, 3 months, 6 months (Six Minute Walk Distance). Mean (Standard Deviation). Unit: meters

Measure	Exercise n = 14
Baseline	498.4 (95.2)
3 months	503.2 (111.1)
6 months	564.2 (139.6)

Exercise: p =0.06, ANOVA
Exercise: p = 0.06, t-test, 2 sided

Population analysed: Transient Ischemic Attack participants who completed the 6 month intervention.

Primary outcome: Cardiovascular Fitness (VO2peak)

Time frame: Baseline (after the 3 month non-intervention period) and after 6 months of participation.. Mean (Standard Deviation). Unit: ml/kg/min

Measure	Exercise n = 14
Baseline	16.7 (5)
6 months	19.1 (4.6)

Exercise: p = 0.01, t-test, 2 sided

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exercise	0 of 20 (0%)	0 of 20 (0%)	Not reported

Limitations and caveats (from the sponsor): This study was conducted in a single centre located in a large city centre and may lack generalizability to other programs, including those where CR services are not publicly funded.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Transient Ischemic Attack

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PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruitingPhase 3
Upfront Lipid-Lowering Therapy With Statins Combined With Hybutimibe in Patients With Acute Ischemic Stroke or Transient Ischemic Attack.
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Recruiting
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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.

Dina Brooks, PhD principal investigator

Toronto Rehabilitation Institute

William E McIllroy, 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?

An observational study of Transient Ischemic Attack, 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 3 inclusion and 9 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 Apr 2019. 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?

Yes. Results are posted in the registry (first posted 23 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Walk Test (time frame: Baseline, 3 months, 6 months (Six Minute Walk Distance)). The study lists 2 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 NCT00929994.

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 Apr 2019.