Effectiveness of Exercise Cardiac Rehabilitation (EFEX-CARE)

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

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.

Study Overview

• Status: Unknown
• Conditions: Cost-effectiveness of Exercise-based Rehabilitation Program
• Intervention / Treatment: Behavioral: Exercise based cardiac rehabilitation

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
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Timo H Mäkikallio, MD; Phone Number: +358400574844; Email: timo.makikallio@ppshp.fi

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cost / quality-adjusted life year of a cardiac patient (QALY)	One year / patient

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Oulu
• Collaborators: Oulu University Hospital; University of Eastern Finland; Verve Research, Oulu, Finland
• Investigators: Study Director: Mikko P Tulppo, PhD, University of Oulu

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: July 30, 2013
• First Submitted That Met QC Criteria: August 1, 2013
• First Posted (Estimate): August 5, 2013

Study Record Updates

• Last Update Posted (Estimate): August 5, 2013
• Last Update Submitted That Met QC Criteria: August 1, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Exercise; Acute coronary syndrome; Physical activity; Cardiac rehabilitation; Cost-effectiveness; Home monitoring
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: Verve-139226