Adapted Cardiac Rehabilitation After Stroke

Sponsor

Toronto Rehabilitation Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01067495

Collaborator

Heart and Stroke Foundation of Ontario (Other)

Enrollment

Location

Arm

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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:

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

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

N/A

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 :

Jan 1, 2006

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Dec 1, 2009

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Cardiorespiratory fitness (aerobic capacity) and walking capacity (6 minute walk test, spatiotemporal gait parameters) [Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (12 months)]

Secondary Outcome Measures

Plasma lipid analysis, questionnaires pertaining to quality of life and community integration [Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (12 months)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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