Effectiveness of Exercise Cardiac Rehabilitation
EFEX-CARE
Effectiveness of Exercise-based Rehabilitation Program for Patients After Acute Coronary Syndrome
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 30, 2013
CompletedFirst Posted
Study publicly available on registry
August 5, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedAugust 5, 2013
August 1, 2013
4.8 years
July 30, 2013
August 1, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cost / quality-adjusted life year of a cardiac patient (QALY)
One year / patient
Secondary Outcomes (1)
Major Adverse Cardiac Event (MACE)
One year / patient
Study Arms (2)
Exercise based cardiac rehabilitation
EXPERIMENTALPatients 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.
Control
NO INTERVENTIONA conventional post-acute care group treated according to finnish guidelines.
Interventions
The cost-effectiveness between the exercise training vs. control groups
Eligibility Criteria
You may qualify if:
- The patients undergo coronary angiography and are diagnosed with coronary artery disease.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oululead
- Verve Research, Oulu, Finlandcollaborator
- University of Eastern Finlandcollaborator
- Oulu University Hospitalcollaborator
Study Sites (1)
Verve
Oulu, 90101, Finland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mikko P Tulppo, PhD
University of Oulu
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Adjunct professor
Study Record Dates
First Submitted
July 30, 2013
First Posted
August 5, 2013
Study Start
February 1, 2011
Primary Completion
December 1, 2015
Study Completion
December 1, 2016
Last Updated
August 5, 2013
Record last verified: 2013-08