Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2011-02-28
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Exercise based cardiac rehabilitation
The cost-effectiveness between the exercise training vs. control groups
Control
A conventional post-acute care group treated according to finnish guidelines.
No interventions assigned to this group
Interventions
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Exercise based cardiac rehabilitation
The cost-effectiveness between the exercise training vs. control groups
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* heart failure
* unstable chest pain (angina pectoris) at the time of randomization
* severe peripheral atherosclerosis (intermittent claudication)
* severe retinopathy or neuropathy related to diabetes.
ALL
No
Sponsors
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Verve Research, Oulu, Finland
OTHER
University of Eastern Finland
OTHER
Oulu University Hospital
OTHER
University of Oulu
OTHER
Responsible Party
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Mikko Tulppo
Adjunct professor
Principal Investigators
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Mikko P Tulppo, PhD
Role: STUDY_DIRECTOR
University of Oulu
Locations
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Verve
Oulu, , Finland
Countries
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Central Contacts
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Facility Contacts
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Mikko P Tulppo, PhD
Role: primary
Other Identifiers
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Verve-139226
Identifier Type: -
Identifier Source: org_study_id