Effectiveness of Exercise Cardiac Rehabilitation

Cost-effectiveness of Exercise-based Rehabilitation Program Clinical Trial

— EFEX-CARE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01916525
• Other study ID #: Verve-139226
• Status: Recruiting
• Phase: N/A
• First received: July 30, 2013
• Last updated: August 1, 2013
• Start date: February 2011
• Est. completion date: December 2016

Study information

• Verified date: August 2013
• Source: University of Oulu
• Contact: Timo H Mäkikallio, MD
• Phone: +358400574844
• Email: timo.makikallio[@]ppshp.fi
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Cost-effectiveness of Exercise-based Rehabilitation Program

Intervention

Behavioral:
• Exercise based cardiac rehabilitation
The cost-effectiveness between the exercise training vs. control groups

Locations

Country	Name	City	State
Finland	Verve	Oulu

Sponsors (4)

Lead Sponsor	Collaborator
University of Oulu	Oulu University Hospital, University of Eastern Finland, Verve Research, Oulu, Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost / quality-adjusted life year of a cardiac patient (QALY)		One year / patient	No
Secondary	Major Adverse Cardiac Event (MACE)	significant clinical adverse events, overall mortality, and acute cardiac arrest or resuscitation from cardiac arrest.	One year / patient	No