Acute Myocardial Infarction Clinical Trial
— HITCAREOfficial title:
High-Intensity Exercise Training in Cardiac Rehabilitation After Acute Coronary Event - Randomized Controlled Trial
Verified date | December 2015 |
Source | Kuopio Research Institute of Exercise Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Despite the well-known health benefits of physical exercise in the prevention of chronic diseases, less attention has been focused on the use of physical exercise as an essential part of good treatment for chronic disease. The aims of the study are to investigate the feasibility, medical effects, cost-effectiveness, and social perspectives of the individualized exercise-based rehabilitation [2 different high-intensity training (HIT) protocols combined with usual care (UC)] after acute coronary artery disease (CAD) event. The medical aim is to study mediating mechanisms of the physiological, biochemical and molecular effects of exercise training on the clinical outcomes. The aim of the health-economic evaluation is to assess the changes in the Health-Related Quality of Life (HRQL) and health care related costs for estimating the cost-effectiveness of HIT-based exercise rehabilitation. The purpose of the sociological analysis is to find out the social processes which make possible the emergence of the desired welfare effects.
Status | Terminated |
Enrollment | 27 |
Est. completion date | December 2019 |
Est. primary completion date | November 14, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - hospital care after acute CAD event (ICD-10 codes I20.0-I22) - age 40-80 years - signed informed consent form Exclusion Criteria: - conditions preventing regular exercise training - severe/malignant disease (life expectancy <12 months) |
Country | Name | City | State |
---|---|---|---|
Finland | Kuopio Research Institute of Exercise Medicine | Kuopio |
Lead Sponsor | Collaborator |
---|---|
Kuopio Research Institute of Exercise Medicine | Kuopio University Hospital, Social Insurance Institution, Finland, University of Basel, University of Eastern Finland |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in ergospirometer variables | Baseline, 6 and 12 months | ||
Other | Change in muscular performance | Baseline, 6 and 12 months | ||
Other | Change in daily energy expenditure | Baseline, 6 and 12 months | ||
Other | Sleeping time | Baseline, 6 and 12 months | ||
Other | Sitting time | Baseline, 6 and 12 months | ||
Other | Dietary habits | Measured by food frequency questionnaire | Baseline, 6 and 12 months | |
Other | Change in chest pain symptoms, exercise induced angina or ischemia | Composite measure based on anamnesis and ECG | Baseline, 6 and 12 months | |
Other | Change in antianginal and other medication | Baseline, 6 and 12 months | ||
Other | Hospitalization due to cardiovascular causes | Baseline, 6 and 12 months | ||
Other | Change in vascular risk factors | Baseline, 6 and 12 months | ||
Other | Progression of peripheral atherosclerosis | Baseline, 6 and 12 months | ||
Other | Change in cognitive function | Baseline and 12 months | ||
Other | Change in depressive symptoms | Baseline, 6 and 12 months | ||
Other | Intervention related adverse events | Throughout the intervention phase | ||
Other | Change in myocardial blood flow capacity and left ventricular function | Baseline and 12 months | ||
Other | Change in myocardial blood flow at rest and during adenosine infusion | Baseline and 12 months | ||
Other | Change in myocardial blood flow reserve | Baseline and 12 months | ||
Other | Change in left ventricular ejection fraction | Baseline and 12 months | ||
Other | Change in left ventricular longitudinal peak systolic strain | Baseline and 12 months | ||
Other | Change in left mitral annular diastolic tissue velocity | Baseline and 12 months | ||
Other | Change in autonomic nervous system control of cardiac function | Baseline and 12 months | ||
Other | Change in body composition | Measured by bioimpedance | Baseline, 6 and 12 months | |
Other | Change in anthropometric measures | Measured by body weight, body height, waist circumference, and hip circumference. Body mass index and waist to hip ratio will be calculated. |
Baseline, 6 and 12 months | |
Other | All-cause death | Baseline, 6 and 12 months; annual follow-up up to 60 months | ||
Other | Cardiovascular death | Baseline, 6 and 12 months; annual follow-up up to 60 months | ||
Primary | Change in cardiorespiratory fitness as assessed by peak oxygen uptake (VO2peak) | Baseline, 6 and 12 months | ||
Secondary | Incremental health care cost/quality-adjusted life-year-relation | Baseline, 6 and 12 months | ||
Secondary | Social processes explaining adherence and motivation to exercise rehabilitation | Social analysis will be performed by specific questionnaires and interviews. Subjective perceptions on the social mechanisms impacting on health and well-being as a part of the rehabilitation processes will be also be modelled using comparative causal mapping techniques (CMT) (See http://www.uef.fi/fi/cmap3). | Baseline, 6 and 12 months | |
Secondary | Total costs of the use of health care services | The use of total health services will be assessed by diary, questionnaire and from registers (national, hospital district and domicile health center). | Baseline, 6 and 12 months | |
Secondary | Utilization of health care resources | Baseline, 6 and 12 months | ||
Secondary | Change in health-related quality of life | Baseline, 6 and 12 months |
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