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Effectiveness of Exercise Cardiac Rehabilitation

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01916525
Acronym
EFEX-CARE
Enrollment
300
Registered
2013-08-05
Start date
2011-02-28
Completion date
2016-12-31
Last updated
2013-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cost-effectiveness of Exercise-based Rehabilitation Program

Keywords

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

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.

Interventions

The cost-effectiveness between the exercise training vs. control groups

Sponsors

Verve Research, Oulu, Finland
CollaboratorOTHER
University of Eastern Finland
CollaboratorOTHER
Oulu University Hospital
CollaboratorOTHER
University of Oulu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Major Adverse Cardiac Event (MACE)One year / patientsignificant clinical adverse events, overall mortality, and acute cardiac arrest or resuscitation from cardiac arrest.

Countries

Finland

Contacts

Primary ContactTimo H Mäkikallio, MD
timo.makikallio@ppshp.fi+358400574844

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026