High-intensity Exercise After Acute Cardiac Event (HITCARE) (HITCARE)

High-Intensity Exercise Training in Cardiac Rehabilitation After Acute Coronary Event - Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Unstable Angina Pectoris; Acute Myocardial Infarction; Recurrent Myocardial Infarction
• Intervention / Treatment: Behavioral: High-intensity aerobic interval training, short interval; Behavioral: High-intensity aerobic interval training, long interval

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Kuopio, Finland, 70100
    • Kuopio Research Institute of Exercise Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-intensity interval training, HIT-S; High-intensity aerobic interval training, short interval (HIT-S)	Behavioral: High-intensity aerobic interval training, short interval; The intensity of HIT-S sessions (cycle ergometer) will be increased during 3 to 6 months from 60% of VO2peak to 100% which will be the target intensity from 6 to 12 months. The protocol includes four 6 min sets consisting of 15 sec exercise followed by 15 sec passive recovery separated with 3 min passive recovery between sets. Exercise session will last ca. 40 min, with 12 min of HIT, warm-up and recovery. The intensity of the 15 seconds exercise bouts will be based on VO2peak at baseline and after 6 months. Meanwhile, the estimated VO2peak from the submaximal test will be used to adjust the training intensity in HIT sessions. Training will be conducted in a group of 1-3 HIT-S patients with ECG monitoring and supervised by physician.
Experimental: High-intensity interval training, HIT-L; High-intensity aerobic interval training, long interval (HIT-L)	Behavioral: High-intensity aerobic interval training, long interval; The intensity of HIT-L sessions (cycle ergometer) will be increased during 3 to 6 months from 60% of VO2peak to 90% which will be the target intensity from 6 to 12 months. The protocol includes four 3 min exercise bouts with a 4 min recovery (pedaling at 0 W) between bouts. Exercise session will last ca. 40 min, with 12 min of HIT, warm-up and recovery. The intensity of the 3 min exercise bouts will be based on VO2peak at baseline and after 6 months. Meanwhile, the estimated VO2peak from the submaximal test will be used to adjust the training intensity in HIT sessions. Training will be conducted in a group of 1-3 HIT-L patients with ECG monitoring and supervised by physician.
No Intervention: Usual care; control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in cardiorespiratory fitness as assessed by peak oxygen uptake (VO2peak)	Baseline, 6 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incremental health care cost/quality-adjusted life-year-relation		Baseline, 6 and 12 months
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
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
Utilization of health care resources		Baseline, 6 and 12 months
Change in health-related quality of life		Baseline, 6 and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ergospirometer variables		Baseline, 6 and 12 months
Change in muscular performance		Baseline, 6 and 12 months
Change in daily energy expenditure		Baseline, 6 and 12 months
Sleeping time		Baseline, 6 and 12 months
Sitting time		Baseline, 6 and 12 months
Dietary habits	Measured by food frequency questionnaire	Baseline, 6 and 12 months
Change in chest pain symptoms, exercise induced angina or ischemia	Composite measure based on anamnesis and ECG	Baseline, 6 and 12 months
Change in antianginal and other medication		Baseline, 6 and 12 months
Hospitalization due to cardiovascular causes		Baseline, 6 and 12 months
Change in vascular risk factors		Baseline, 6 and 12 months
Progression of peripheral atherosclerosis		Baseline, 6 and 12 months
Change in cognitive function		Baseline and 12 months
Change in depressive symptoms		Baseline, 6 and 12 months
Intervention related adverse events		Throughout the intervention phase
Change in myocardial blood flow capacity and left ventricular function		Baseline and 12 months
Change in myocardial blood flow at rest and during adenosine infusion		Baseline and 12 months
Change in myocardial blood flow reserve		Baseline and 12 months
Change in left ventricular ejection fraction		Baseline and 12 months
Change in left ventricular longitudinal peak systolic strain		Baseline and 12 months
Change in left mitral annular diastolic tissue velocity		Baseline and 12 months
Change in autonomic nervous system control of cardiac function		Baseline and 12 months
Change in body composition	Measured by bioimpedance	Baseline, 6 and 12 months
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
All-cause death		Baseline, 6 and 12 months; annual follow-up up to 60 months
Cardiovascular death		Baseline, 6 and 12 months; annual follow-up up to 60 months

Collaborators and Investigators

• Sponsor: Kuopio Research Institute of Exercise Medicine
• Collaborators: Kuopio University Hospital; University of Basel; University of Eastern Finland; Social Insurance Institution, Finland
• Investigators: Principal Investigator: Rainer Rauramaa, professor, Kuopio Research Institute of Exercise Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): November 14, 2016
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: September 3, 2014
• First Submitted That Met QC Criteria: September 8, 2014
• First Posted (Estimate): September 10, 2014

Study Record Updates

• Last Update Posted (Estimate): January 24, 2017
• Last Update Submitted That Met QC Criteria: January 23, 2017
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Myocardial Infarction; Infarction; Angina Pectoris; Angina, Unstable
• Other Study ID Numbers: 1072011