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Effectiveness of Exercise Cardiac Rehabilitation (EFEX-CARE)

Primary Purpose

Cost-effectiveness of Exercise-based Rehabilitation Program

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Exercise based cardiac rehabilitation
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cost-effectiveness of Exercise-based Rehabilitation Program focused on measuring Acute coronary syndrome, Cost-effectiveness, Cardiac rehabilitation, Exercise, Physical activity, Home monitoring

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VerveRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise based cardiac rehabilitation

Control

Arm Description

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.

A conventional post-acute care group treated according to finnish guidelines.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Major Adverse Cardiac Event (MACE)
significant clinical adverse events, overall mortality, and acute cardiac arrest or resuscitation from cardiac arrest.

Full Information

First Posted
July 30, 2013
Last Updated
August 1, 2013
Sponsor
University of Oulu
Collaborators
Verve Research, Oulu, Finland, University of Eastern Finland, Oulu University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01916525
Brief Title
Effectiveness of Exercise Cardiac Rehabilitation
Acronym
EFEX-CARE
Official Title
Effectiveness of Exercise-based Rehabilitation Program for Patients After Acute Coronary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
Collaborators
Verve Research, Oulu, Finland, University of Eastern Finland, Oulu University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cost-effectiveness of Exercise-based Rehabilitation Program
Keywords
Acute coronary syndrome, Cost-effectiveness, Cardiac rehabilitation, Exercise, Physical activity, Home monitoring

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise based cardiac rehabilitation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
A conventional post-acute care group treated according to finnish guidelines.
Intervention Type
Behavioral
Intervention Name(s)
Exercise based cardiac rehabilitation
Intervention Description
The cost-effectiveness between the exercise training vs. control groups
Primary Outcome Measure Information:
Title
Cost / quality-adjusted life year of a cardiac patient (QALY)
Time Frame
One year / patient
Secondary Outcome Measure Information:
Title
Major Adverse Cardiac Event (MACE)
Description
significant clinical adverse events, overall mortality, and acute cardiac arrest or resuscitation from cardiac arrest.
Time Frame
One year / patient

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Timo H Mäkikallio, MD
Phone
+358400574844
Email
timo.makikallio@ppshp.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mikko P Tulppo, PhD
Organizational Affiliation
University of Oulu
Official's Role
Study Director
Facility Information:
Facility Name
Verve
City
Oulu
ZIP/Postal Code
90101
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikko P Tulppo, PhD
Phone
+358405081902
Email
mikko.tulppo@verve.fi
First Name & Middle Initial & Last Name & Degree
Arto J Hautala, PhD

12. IPD Sharing Statement

Learn more about this trial

Effectiveness of Exercise Cardiac Rehabilitation

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