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Completed

NCT Number: NCT01067495

Adapted Cardiac Rehabilitation After Stroke

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.

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Key information

Conditions

Stroke Behavior Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Motor Activity Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Toronto Rehabilitation Institute Cardiac Rehabilitation and Secondary Prevention Program - Rumsey Centre

Toronto, Ontario, M4G 1R7, Canada

About this study

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:

  • 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.
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac rehabilitation

Behavioral

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Toronto Rehabilitation Institute

Other

Collaborators

  • Heart and Stroke Foundation of Ontario

Registry information

Official study title

Feasibility and Effects of Cardiac Rehabilitation for Individuals After Stroke

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Feb 11, 2010
Registry last updated
Feb 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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