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临床试验/NCT03394183
NCT03394183撤回不适用

Comparing the Efficacy of Cardiac Rehabilitation for Patients With Peripheral Artery Disease to Patients With Coronary Artery Disease

University Health Network, Toronto2 个研究点 分布在 1 个国家开始时间: 2018年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Cardiorespiratory Fitness

研究概览

简要总结

Exercise is commonly recommended as a treatment for patients who present with peripheral artery disease (PAD). Although a great deal of research has supported the efficacy of exercise rehabilitation for PAD, it is infrequently implemented into clinical practices.To date, no comparison of cardiac rehabilitation efficacy and acute exercise responses has been made between patients with PAD and patients with coronary artery disease (CAD). Considering some of the parallels between the two conditions, as they are both atherosclerotic conditions, and the strong recommendations for exercise in both populations, it is worthwhile to compare the efficacy of cardiac rehabilitation responses. It is also unclear if the magnitude of response for PAD patients is dependent on biological sex and clinical presentation as this may influence the development of exercise prescriptions. This study will be a prospective two-arm cohort study with both groups (CAD and PAD) undergoing the same intervention (standard 6 month out-patient cardiac rehabilitation program offered at the Toronto Rehabilitation Institute Rumsey Centre). The primary variable of interest will be peak oxygen consumption (VO2peak) with a secondary variable of interest being functional capacity, as measured by the 6-minute walk test. Tertiary variables of interest will include walking impairment, as measured by the Walking Impairment Questionnaire, and quality of life, as measured by the Short Form-36 health survey (SF-36).The second objective of this study is to determine if the magnitude of responses to cardiac rehabilitation for patients with PAD are dependent on biological sex or type of PAD (asymptomatic, post-surgical intervention, or intermittent claudication).Exploratory objectives include comparing acute exercise responses (prescribed exercise training load, actual training load, exercising heart rate and rating of perceived exertion) between PAD and CAD patients.

详细描述

This study is a prospective two-arm cohort study with both groups (CAD and PAD) undergoing the same intervention (standard 6 month out-patient cardiac rehabilitation program offered at the Toronto Rehabilitation Institute Rumsey Centre). The standard 6-month out-patient cardiac rehabilitation program consists of weekly 1.5 hour visits to the TRI Rumsey Centre. After determining baseline VO2peak from the exercise stress test, an individualized walking exercise prescription will be developed by a cardiac rehabilitation supervisor which corresponds to approximately 60 to 80% of the participant's VO2peak. Participants will be invited to walk around the track and attend education sessions at the same time every week for six months. Patients will be encouraged to gradually increase their exercise time walking speed. Patients will be encouraged to exercise five times a week with four sessions occurring outside of the cardiac rehabilitation program. Both PAD and CAD participants will undergo the same standard cardiac rehabilitation program.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed with lower extremity PAD or CAD
  • diagnosed with concomitant PAD and CAD

排除标准

  • vascular aneurysms, chronic heart failure, cancer, stroke, respiratory disease, or chronic kidney disease
  • foot ulcers or skin breakdowns which may impede ability to exercise
  • cannot follow instructions in English

研究组 & 干预措施

Peripheral Artery Disease Participants

Experimental

Patients diagnosed with peripheral artery disease will undergo a 6 month cardiac rehabilitation program that is standard of care at the Toronto Rehabilitation Institute Rumsey Centre.

干预措施: Cardiac Rehabilitation (Other)

Coronary Artery Disease Participants

Active Comparator

Patients diagnosed with coronary artery disease will undergo a 6 month cardiac rehabilitation program that is standard of care at the Toronto Rehabilitation Institute Rumsey Centre. The responses to cardiac rehabilitation for participants with coronary artery disease will be compared to participants with peripheral artery disease.

干预措施: Cardiac Rehabilitation (Other)

结局指标

主要结局

Cardiorespiratory Fitness

时间窗: 6 months

Relative VO2peak in ml/kg/min

次要结局

  • Magnitude of Response(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cindy Nguyen

Principal Investigator

University Health Network, Toronto

研究点 (2)

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