Effectiveness of Exercise Cardiac Rehabilitation (EFEX-CARE)

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Cost-effectiveness of Exercise-based Rehabilitation Program	Behavioral: Exercise based cardiac rehabilitation	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	300 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Effectiveness of Exercise-based Rehabilitation Program for Patients After Acute Coronary Syndrome
Study Start Date :	February 2011
Estimated Primary Completion Date :	December 2015
Estimated Study Completion Date :	December 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Exercise based cardiac rehabilitation; 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.	Behavioral: Exercise based cardiac rehabilitation; The cost-effectiveness between the exercise training vs. control groups
No Intervention: Control; A conventional post-acute care group treated according to finnish guidelines.

Outcome Measures

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Primary Outcome Measures :

1. Cost / quality-adjusted life year of a cardiac patient (QALY) [ Time Frame: One year / patient ]

Secondary Outcome Measures :

1. Major Adverse Cardiac Event (MACE) [ Time Frame: One year / patient ]
   significant clinical adverse events, overall mortality, and acute cardiac arrest or resuscitation from cardiac arrest.

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Timo H Mäkikallio, MD	+358400574844	timo.makikallio@ppshp.fi

Locations

Finland
Verve	Recruiting
Oulu, Finland, 90101
Contact: Mikko P Tulppo, PhD +358405081902 mikko.tulppo@verve.fi
Principal Investigator: Arto J Hautala, PhD

Sponsors and Collaborators

University of Oulu

Verve Research, Oulu, Finland

University of Eastern Finland

Oulu University Hospital

Investigators

Study Director:	Mikko P Tulppo, PhD	University of Oulu

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Mikko Tulppo, Adjunct professor, University of Oulu
ClinicalTrials.gov Identifier:	NCT01916525 History of Changes
Other Study ID Numbers:	Verve-139226
First Posted:	August 5, 2013
Last Update Posted:	August 5, 2013
Last Verified:	August 2013

Keywords provided by Mikko Tulppo, University of Oulu:

Acute coronary syndrome; Cost-effectiveness; Cardiac rehabilitation	Exercise; Physical activity; Home monitoring

Additional relevant MeSH terms:

Acute Coronary Syndrome; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases