Adapted Cardiac Rehabilitation After Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Cardiac rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring stroke, rehabilitation, exercise, walking, risk factors
Eligibility 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
Sites / Locations
- Toronto Rehabilitation Institute Cardiac Rehabilitation and Secondary Prevention Program - Rumsey Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise
Arm Description
Outcomes
Primary Outcome Measures
Cardiorespiratory fitness (aerobic capacity) and walking capacity (6 minute walk test, spatiotemporal gait parameters)
Secondary Outcome Measures
Plasma lipid analysis, questionnaires pertaining to quality of life and community integration
Full Information
NCT ID
NCT01067495
First Posted
February 8, 2010
Last Updated
February 10, 2010
Sponsor
Toronto Rehabilitation Institute
Collaborators
Heart and Stroke Foundation of Ontario
1. Study Identification
Unique Protocol Identification Number
NCT01067495
Brief Title
Adapted Cardiac Rehabilitation After Stroke
Official Title
Feasibility and Effects of Cardiac Rehabilitation for Individuals After Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Toronto Rehabilitation Institute
Collaborators
Heart and Stroke Foundation of Ontario
4. Oversight
Data Monitoring Committee
No
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, rehabilitation, exercise, walking, risk factors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Cardiac rehabilitation
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William E McIlroy, PhD
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Oh, MD
Organizational Affiliation
Toronto Rehabilitation Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto Rehabilitation Institute Cardiac Rehabilitation and Secondary Prevention Program - Rumsey Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 1R7
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
20529376
Citation
Tang A, Marzolini S, Oh P, McIlroy WE, Brooks D. Feasibility and effects of adapted cardiac rehabilitation after stroke: a prospective trial. BMC Neurol. 2010 Jun 9;10:40. doi: 10.1186/1471-2377-10-40.
Results Reference
derived
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Adapted Cardiac Rehabilitation After Stroke
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