Cost-effectiveness of Exercise-based Rehabilitation ProgramEFEX-CARENCT01916525
Effectiveness of Exercise Cardiac Rehabilitation
A study testing Exercise based cardiac rehabilitation in people with Cost-effectiveness of Exercise-based Rehabilitation Program, run by University of Oulu at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cost-effectiveness of Exercise-based Rehabilitation Program
- What is being tested?
- Exercise based cardiac rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFinland
- Study dates
- Feb 2011to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patients undergo coronary angiography and are diagnosed with coronary artery disease.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Verve
Oulu, 90101
Mikko P Tulppo, PhD, +358405081902, mikko.tulppo@verve.fi
Arto J Hautala, PhD
About this study
Official title: Effectiveness of Exercise-based Rehabilitation Program for Patients After Acute Coronary Syndrome
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.
Read the 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.
- Being tested
- Exercise based cardiac rehabilitation
- Keywords
- Acute coronary syndrome, Cost-effectiveness, Cardiac rehabilitation, Exercise, Physical activity, Home monitoring
- Medical subject headings
- Acute Coronary Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise based cardiac rehabilitationBehavioural
The cost-effectiveness between the exercise training vs. control groups
| Study group | Role | What they receive |
|---|---|---|
| Exercise based cardiac rehabilitation | Experimental | 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. Receives: Behavioral: Exercise based cardiac rehabilitation |
| Control | No intervention | A conventional post-acute care group treated according to finnish guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost / quality-adjusted life year of a cardiac patient (QALY)
Measured: One year / patient
Secondary outcomes (1)
Major Adverse Cardiac Event (MACE)
significant clinical adverse events, overall mortality, and acute cardiac arrest or resuscitation from cardiac arrest.
Measured: One year / patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startFeb 2011
- Primary completionDec 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cost-effectiveness of Exercise-based Rehabilitation ProgramStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- Verve Research, Oulu, Finland, University of Eastern Finland, Oulu University Hospital
- Responsible party
- Principal investigator, Mikko Tulppo, University of Oulu
- Investigators
- Mikko P Tulppo, PhD, Study director, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916525
- Sponsor's protocol ID
- Verve-139226
- Acronym
- EFEX-CARE
- Status last verified
- Aug 2013
- First submitted
- 30 Jul 2013
- Last updated
- 5 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Exercise-based Rehabilitation Program for Patients After Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT01916525
- Acronym / sponsor ID
- EFEX-CARE / Verve-139226
- Keywords
- Acute coronary syndrome, Cost-effectiveness, Cardiac rehabilitation, Exercise, Physical activity, Home monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- Verve Research, Oulu, Finland, University of Eastern Finland, Oulu University Hospital
- Study start
- Feb 2011
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 5 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise based cardiac rehabilitation | Experimental | Behavioral: Exercise based cardiac rehabilitationPatients 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 intervention | –A conventional post-acute care group treated according to finnish guidelines. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- The patients undergo coronary angiography and are diagnosed with coronary artery disease.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise based cardiac rehabilitationThe cost-effectiveness between the exercise training vs. control groups | Behavioural | Exercise based cardiac rehabilitation |
Primary outcome
Cost / quality-adjusted life year of a cardiac patient (QALY)
Time frame: One year / patient
1 secondary outcome
Major Adverse Cardiac Event (MACE)
Time frame: One year / patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikko P Tulppo, PhD study director
University of Oulu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise based cardiac rehabilitation in people with Cost-effectiveness of Exercise-based Rehabilitation Program, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Timo H Mäkikallio, MD (+358400574844, timo.makikallio@ppshp.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost / quality-adjusted life year of a cardiac patient (QALY) (time frame: One year / patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2013.