Adapted Cardiac Rehabilitation After Stroke
Feasibility and Effects of Cardiac Rehabilitation for Individuals 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.
연구 개요
상세 설명
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
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M4G 1R7
- Toronto Rehabilitation Institute Cardiac Rehabilitation and Secondary Prevention Program - Rumsey Centre
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 연습
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Cardiorespiratory fitness (aerobic capacity) and walking capacity (6 minute walk test, spatiotemporal gait parameters)
기간: Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (12 months)
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Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (12 months)
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Plasma lipid analysis, questionnaires pertaining to quality of life and community integration
기간: Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (12 months)
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Pre-baseline (-3 months), pre-program (0 months), post-program (6 months), follow up (12 months)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Paul Oh, MD, Toronto Rehabilitation Institute
- 수석 연구원: William E McIlroy, PhD, University of Waterloo
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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