Effectiveness of Exercise Cardiac Rehabilitation (EFEX-CARE)
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Purpose
| Condition | Intervention |
|---|---|
|
Cost-effectiveness of Exercise-based Rehabilitation Program |
Behavioral: Exercise based cardiac rehabilitation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Effectiveness of Exercise-based Rehabilitation Program for Patients After Acute Coronary Syndrome |
- Cost / quality-adjusted life year of a cardiac patient (QALY) [ Time Frame: One year / patient ] [ Designated as safety issue: No ]
- Major Adverse Cardiac Event (MACE) [ Time Frame: One year / patient ] [ Designated as safety issue: No ]significant clinical adverse events, overall mortality, and acute cardiac arrest or resuscitation from cardiac arrest.
| Estimated Enrollment: | 300 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Genders Eligible for Study: | Both |
| 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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01916525
| Contact: Timo H Mäkikallio, MD | +358400574844 | timo.makikallio@ppshp.fi |
| Finland | |
| Verve | Recruiting |
| Oulu, Finland, 90101 | |
| Contact: Mikko P Tulppo, PhD +358405081902 mikko.tulppo@verve.fi | |
| Principal Investigator: Arto J Hautala, PhD | |
| Study Director: | Mikko P Tulppo, PhD | University of Oulu |
More Information
| Responsible Party: | Mikko Tulppo, Adjunct professor, University of Oulu |
| ClinicalTrials.gov Identifier: | NCT01916525 History of Changes |
| Other Study ID Numbers: | Verve-139226 |
| Study First Received: | July 30, 2013 |
| Last Updated: | August 1, 2013 |
| Health Authority: | Finland: Ethics Committee |
Keywords provided by 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 |
ClinicalTrials.gov processed this record on September 27, 2016