Clinical trial NCT01916525: Effectiveness of Exercise Cardiac Rehabilitation
Official title: Effectiveness of Exercise-based Rehabilitation Program for Patients After Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cost-effectiveness of Exercise-based Rehabilitation Program
Keywords: Acute coronary syndrome
Cost-effectiveness
Cardiac rehabilitation
Exercise
Physical activity
Home monitoring
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Verve Research, Oulu, Finland
name: University of Eastern Finland
name: Oulu University Hospital
First posted: 2013-08-05
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Cost / quality-adjusted life year of a cardiac patient (QALY)
timeFrame: One year / patient
Secondary outcomes:
measure: Major Adverse Cardiac Event (MACE)
timeFrame: One year / patient
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Verve
Study officials:
affiliation: University of Oulu
name: Mikko P Tulppo, PhD
role: STUDY_DIRECTOR
References: