NCT00929994

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

April 23, 2019

Completed
Last Updated

April 23, 2019

Status Verified

April 1, 2019

Enrollment Period

4.7 years

First QC Date

June 29, 2009

Results QC Date

April 15, 2017

Last Update Submit

April 20, 2019

Conditions

Keywords

cardiac rehab

Outcome Measures

Primary Outcomes (2)

  • Functional Walk Test

    6 minute walk test: the longest distance a person can walk for a duration of 6 minutes

    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.

    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).

    Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation

  • Cognition

    Baseline and 3 months (non-intervention period), after 6 months of cardiac rehabilitation participation

Study Arms (1)

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.

Behavioral: Cardiac Rehabilitation

Interventions

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

Exercise

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

TIA

You may qualify if:

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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto Rehabilitation Institute - Rumsey Center

Toronto, Ontario, M4G 1R7, Canada

Location

MeSH Terms

Conditions

Ischemic Attack, Transient

Interventions

Cardiac Rehabilitation

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Limitations and Caveats

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.

Results Point of Contact

Title
Dr.
Organization
Toronto Rehab

Study Officials

  • Dina Brooks, PhD

    Toronto Rehabilitation Institute

    PRINCIPAL INVESTIGATOR
  • William E McIllroy, PhD

    University of Waterloo

    PRINCIPAL INVESTIGATOR
  • Paul Oh, MD

    Toronto Rehabilitation Institute

    PRINCIPAL INVESTIGATOR
  • Sandra Black, MD

    Sunnybrook and Women's College Health Centre

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 29, 2009

First Posted

June 30, 2009

Study Start

March 1, 2010

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

April 23, 2019

Results First Posted

April 23, 2019

Record last verified: 2019-04

Locations