Trial record 18 of 288 for:    child [AGE-GROUP] AND exercise [TREATMENT] | Open Studies

Effectiveness of Exercise Cardiac Rehabilitation (EFEX-CARE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Oulu
Sponsor:
Collaborators:
Verve
University of Eastern Finland
Oulu City Hospital
Information provided by (Responsible Party):
Mikko Tulppo, University of Oulu
ClinicalTrials.gov Identifier:
NCT01916525
First received: July 30, 2013
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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.


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

Resource links provided by NLM:


Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Cost / quality-adjusted life year of a cardiac patient (QALY) [ Time Frame: One year / patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01916525

Contacts
Contact: Timo H Mäkikallio, MD +358400574844 timo.makikallio@ppshp.fi

Locations
Finland
Verve Recruiting
Oulu, Finland, 90101
Contact: Mikko P Tulppo, PhD    +358405081902    mikko.tulppo@verve.fi   
Principal Investigator: Arto J Hautala, PhD         
Sponsors and Collaborators
University of Oulu
Verve
University of Eastern Finland
Oulu City Hospital
Investigators
Study Director: Mikko P Tulppo, PhD University of Oulu
  More Information

No publications provided

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
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014