Effectiveness of Exercise Cardiac Rehabilitation (EFEX-CARE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01916525
Recruitment Status : Unknown
Verified August 2013 by Mikko Tulppo, University of Oulu.
Recruitment status was:  Recruiting
First Posted : August 5, 2013
Last Update Posted : August 5, 2013
Verve Research, Oulu, Finland
University of Eastern Finland
Oulu University Hospital
Information provided by (Responsible Party):
Mikko Tulppo, University of Oulu

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 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

Resource links provided by the National Library of Medicine

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.

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.

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01916525

Contact: Timo H Mäkikallio, MD +358400574844

Verve Recruiting
Oulu, Finland, 90101
Contact: Mikko P Tulppo, PhD    +358405081902   
Principal Investigator: Arto J Hautala, PhD         
Sponsors and Collaborators
University of Oulu
Verve Research, Oulu, Finland
University of Eastern Finland
Oulu University Hospital
Study Director: Mikko P Tulppo, PhD University of Oulu

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

Keywords provided by Mikko Tulppo, University of Oulu:
Acute coronary syndrome
Cardiac rehabilitation
Physical activity
Home monitoring

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases