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Adapted Cardiac Rehabilitation After Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01067495
Recruitment Status : Completed
First Posted : February 11, 2010
Last Update Posted : February 11, 2010
Heart and Stroke Foundation of Ontario
Information provided by:
Toronto Rehabilitation Institute

Brief 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.

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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Cardiac rehabilitation Phase 1

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:

  1. 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.
  2. 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Effects of Cardiac Rehabilitation for Individuals After Stroke
Study Start Date : January 2006
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Exercise Behavioral: Cardiac rehabilitation
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.

Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067495

Canada, Ontario
Toronto Rehabilitation Institute Cardiac Rehabilitation and Secondary Prevention Program - Rumsey Centre
Toronto, Ontario, Canada, M4G 1R7
Sponsors and Collaborators
Toronto Rehabilitation Institute
Heart and Stroke Foundation of Ontario
Principal Investigator: William E McIlroy, PhD University of Waterloo
Principal Investigator: Paul Oh, MD Toronto Rehabilitation Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dina Brooks, Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT01067495     History of Changes
Other Study ID Numbers: HSFO-SRA5977
First Posted: February 11, 2010    Key Record Dates
Last Update Posted: February 11, 2010
Last Verified: February 2010

Keywords provided by Toronto Rehabilitation Institute:
risk factors

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases