Skip to main content
Clinical Trials/NCT01916525
NCT01916525
Unknown
N/A

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

University of Oulu1 site in 1 country300 target enrollmentFebruary 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cost-effectiveness of Exercise-based Rehabilitation Program
Sponsor
University of Oulu
Enrollment
300
Locations
1
Primary Endpoint
Cost / quality-adjusted life year of a cardiac patient (QALY)
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
December 2016
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mikko Tulppo

Adjunct professor

University of Oulu

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.

Outcomes

Primary Outcomes

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

Time Frame: One year / patient

Secondary Outcomes

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

Study Sites (1)

Loading locations...

Similar Trials