Adapted Cardiac Rehabilitation After Stroke

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by:
Toronto Rehabilitation Institute
ClinicalTrials.gov Identifier:
NCT01067495
First received: February 8, 2010
Last updated: February 10, 2010
Last verified: February 2010
  Purpose

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 Intervention Phase
Stroke
Behavioral: Cardiac rehabilitation
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Feasibility and Effects of Cardiac Rehabilitation for Individuals After Stroke

Resource links provided by NLM:


Further study details as provided by Toronto Rehabilitation Institute:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: January 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01067495

Locations
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
Investigators
Principal Investigator: William E McIlroy, PhD University of Waterloo
Principal Investigator: Paul Oh, MD Toronto Rehabilitation Institute
  More Information

No publications provided by Toronto Rehabilitation Institute

Additional 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
Study First Received: February 8, 2010
Last Updated: February 10, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Toronto Rehabilitation Institute:
stroke
rehabilitation
exercise
walking
risk factors

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014