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.|
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Cost-effectiveness of Exercise-based Rehabilitation Program||Behavioral: Exercise based cardiac rehabilitation||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Cost / quality-adjusted life year of a cardiac patient (QALY) [ Time Frame: One year / patient ]
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01916525
|Contact: Timo H Mäkikallio, MDfirstname.lastname@example.org|
|Oulu, Finland, 90101|
|Contact: Mikko P Tulppo, PhD +358405081902 email@example.com|
|Principal Investigator: Arto J Hautala, PhD|
|Study Director:||Mikko P Tulppo, PhD||University of Oulu|