Clinical trial NCT02235753: High-intensity Exercise After Acute Cardiac Event (HITCARE)
Official title: High-Intensity Exercise Training in Cardiac Rehabilitation After Acute Coronary Event - Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Unstable Angina Pectoris
Acute Myocardial Infarction
Recurrent Myocardial Infarction
Lead sponsor: Kuopio Research Institute of Exercise Medicine
Sponsor class: OTHER
Collaborators: name: Social Insurance Institution, Finland
name: Kuopio University Hospital
name: University of Eastern Finland
name: University of Basel
First posted: 2014-09-10
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The study population consists of patients living in the city of Kuopio or Siilinjarvi area in Eastern Finland, who have been treated in Kuopio University Hospital because of acute CAD event. After baseline measurements, the patients will be randomized into one of the 3 groups: short interval HIT protocol (HIT-S), long interval HIT protocol (HIT-L) or UC group. The intervention will be 12 months per patient and the expected duration of the whole study (intervention data collection) is estimated to be 4 years. In addition, all groups will have annual follow-up examinations scheduled up to 60 months after initiation of the intervention phase. The patients recruited for the study will be 750, a total of 250 patients per study group.

All measurements related to intervention will be performed at Kuopio Research Institute of Exercise Medicine. Examinations concerning myocardial structure and perfusion will be done at Turku PET Center (subsample).

The study complies with the Helsinki declaration, follows good clinical practice. Patient safety will follow normal medical practice. The intervention is not anticipated to cause health risks apart from the conventional treatment. All participants will be provided with diverse individualized information about their health and physical performance. The research methods employed in the study are safe. Physician and nurse will be present at each occasion when physically strenuous measurements are performed and careful provisions for appropriate first aid will be made. The measurements assessing cardiorespiratory and muscular fitness will involve hard effort and it is not unusual to feel innocent muscle pain for a few days after measurements demanding maximal effort. The other potential acute complications may include accidents (e.g. injuries due to slipping or falling) and medical emergencies like acute myocardial infarction.

Study hypotheses:

1. Short (15 sec) and long interval (3 min) high-intensity aerobic interval training (HIT) combined with resistance training after acute CAD event are equally effective in improving cardiorespiratory fitness compared with UC.
2. Despite higher unit costs, the differences in health-related quality of life effects are so large that both HIT interventions are cost-effective compared with UC.
3. Patient's experiences and interpretation of HIT exercise as well as different social processes during rehabilitation explain the cost-effectiveness of the rehabilitation.
4. Patient groups who will or will not benefit of HIT interventions can be identified and predicted.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in cardiorespiratory fitness as assessed by peak oxygen uptake (VO2peak)
timeFrame: Baseline, 6 and 12 months
Secondary outcomes:
measure: Incremental health care cost/quality-adjusted life-year-relation
timeFrame: Baseline, 6 and 12 months
measure: Social processes explaining adherence and motivation to exercise rehabilitation
timeFrame: Baseline, 6 and 12 months
measure: Total costs of the use of health care services
timeFrame: Baseline, 6 and 12 months
measure: Utilization of health care resources
timeFrame: Baseline, 6 and 12 months
measure: Change in health-related quality of life
timeFrame: Baseline, 6 and 12 months
Other outcomes:
measure: Change in ergospirometer variables
timeFrame: Baseline, 6 and 12 months
measure: Change in muscular performance
timeFrame: Baseline, 6 and 12 months
measure: Change in daily energy expenditure
timeFrame: Baseline, 6 and 12 months
measure: Sleeping time
timeFrame: Baseline, 6 and 12 months
measure: Sitting time
timeFrame: Baseline, 6 and 12 months
measure: Dietary habits
timeFrame: Baseline, 6 and 12 months
measure: Change in chest pain symptoms, exercise induced angina or ischemia
timeFrame: Baseline, 6 and 12 months
measure: Change in antianginal and other medication
timeFrame: Baseline, 6 and 12 months
measure: Hospitalization due to cardiovascular causes
timeFrame: Baseline, 6 and 12 months
measure: Change in vascular risk factors
timeFrame: Baseline, 6 and 12 months
measure: Progression of peripheral atherosclerosis
timeFrame: Baseline, 6 and 12 months
measure: Change in cognitive function
timeFrame: Baseline and 12 months
measure: Change in depressive symptoms
timeFrame: Baseline, 6 and 12 months
measure: Intervention related adverse events
timeFrame: Throughout the intervention phase
measure: Change in myocardial blood flow capacity and left ventricular function
timeFrame: Baseline and 12 months
measure: Change in myocardial blood flow at rest and during adenosine infusion
timeFrame: Baseline and 12 months
measure: Change in myocardial blood flow reserve
timeFrame: Baseline and 12 months
measure: Change in left ventricular ejection fraction
timeFrame: Baseline and 12 months
measure: Change in left ventricular longitudinal peak systolic strain
timeFrame: Baseline and 12 months
measure: Change in left mitral annular diastolic tissue velocity
timeFrame: Baseline and 12 months
measure: Change in autonomic nervous system control of cardiac function
timeFrame: Baseline and 12 months
measure: Change in body composition
timeFrame: Baseline, 6 and 12 months
measure: Change in anthropometric measures
timeFrame: Baseline, 6 and 12 months
measure: All-cause death
timeFrame: Baseline, 6 and 12 months; annual follow-up up to 60 months
measure: Cardiovascular death
timeFrame: Baseline, 6 and 12 months; annual follow-up up to 60 months
Locations:
city: Kuopio
country: Finland
facility: Kuopio Research Institute of Exercise Medicine
Study officials:
affiliation: Kuopio Research Institute of Exercise Medicine
name: Rainer Rauramaa, professor
role: PRINCIPAL_INVESTIGATOR
References: