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临床试验/NCT01916525
NCT01916525Unknown不适用

Effectiveness of Exercise-based Rehabilitation Program for Patients After Acute Coronary Syndrome

University of Oulu1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Cost / quality-adjusted life year of a cardiac patient (QALY)

研究概览

简要总结

The objective of this multidisciplinary study is to employ health-economic evaluation in determining the health benefits achieved with exercise-based cardiac rehabilitation and the costs derived from it compared with conventional post-acute care of cardiac patients in the Finnish health care system.

详细描述

The cost-effectiveness of exercise-based cardiac rehabilitation has not been systematically studied earlier in Finland, and it is not justifiable to directly apply the results of studies done in other countries to circumstances in Finland due to differences in the health care and social security systems between the countries. The research will utilize top Finnish expertise spanning clinical cardiology, health economics, and physical education. The hypothesis is that a quality-adjusted life year of a cardiac patient (cost/QALY) is 20 % less costly in a rehabilitation group than in a conventional post-acute care group.

The participants in the study will be recruited from Oulu University Hospital patients from the Oulu region (n = 300) who have suffered acute coronary syndrome (angiographically diagnosed coronary artery disease). Of these patients, 130 will be randomized to exercise-based cardiac rehabilitation (Verve) and 170 to a control group. Dropping out of the intervention will be mini-mized by means of careful definition of the inclusion criteria and close follow-up. The rehabilitation will seek to implement the most recent international recommendations for health-enhancing physical activity (% of those who achieved the exercise target). Instructions for a progressive training model will be compiled. The amount of exercise will be monitored objectively with a wrist-worn device based on wellness technology. Subjective loading of both the training and health-enhancing physical activity will be monitored using self-evaluation. The study will last one year for each patient, after which cost-effectiveness will be analyzed (University of Eastern Finland). The results of the research will facilitate decision making and choices in Finnish health care when arranging rehabilitation for cardiac patients and planning the optimal utilization of health care resources.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • The patients undergo coronary angiography and are diagnosed with coronary artery disease.

排除标准

  • New York Heart Association (NYHA) class IV
  • heart failure
  • unstable chest pain (angina pectoris) at the time of randomization
  • severe peripheral atherosclerosis (intermittent claudication)
  • severe retinopathy or neuropathy related to diabetes.

研究组 & 干预措施

Exercise based cardiac rehabilitation

Experimental

Patients will receive written instructions and a referral to the exercise-based rehabilitation unit. The patient will be taught to use fitness room. Each session of training will be controlled by heart rate. Instruction will also be given for at-home training and filling in a training diary, and training will be scheduled at Verve once a week. On the first visit the patient will receive a device that measures physical activity during the study. Training will also be monitored from the training diary. Structured questionnaires will be used to check compliance and implementation of care will be determined from medication and other health-related habits once a month (during the first 6 months) and finally after 12 months.

干预措施: Exercise based cardiac rehabilitation (Behavioral)

Control

No Intervention

A conventional post-acute care group treated according to finnish guidelines.

结局指标

主要结局

Cost / quality-adjusted life year of a cardiac patient (QALY)

时间窗: One year / patient

次要结局

  • Major Adverse Cardiac Event (MACE)(One year / patient)

研究者

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

Mikko Tulppo

Adjunct professor

University of Oulu

研究点 (1)

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