High-intensity Exercise After Acute Cardiac Event (HITCARE)

NCT02235753 | Terminated DMC

• 1 other identifier: 1072011
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Unstable Angina Pectoris; Acute Myocardial Infarction; Recurrent Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• Change in cardiorespiratory fitness as assessed by peak oxygen uptake (VO2peak)

  Baseline, 6 and 12 months

Secondary Outcomes (5)

• Incremental health care cost/quality-adjusted life-year-relation

  Baseline, 6 and 12 months

• Social processes explaining adherence and motivation to exercise rehabilitation

  Baseline, 6 and 12 months

• Total costs of the use of health care services

  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 Outcomes (25)

• 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

Study Arms (3)

High-intensity interval training, HIT-S

EXPERIMENTAL

High-intensity aerobic interval training, short interval (HIT-S)

Behavioral: High-intensity aerobic interval training, short interval

High-intensity interval training, HIT-L

EXPERIMENTAL

High-intensity aerobic interval training, long interval (HIT-L)

Behavioral: High-intensity aerobic interval training, long interval

Usual care

NO INTERVENTION

control group

Interventions

High-intensity aerobic interval training, short interval BEHAVIORAL

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.

High-intensity interval training, HIT-S

High-intensity aerobic interval training, long interval BEHAVIORAL

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.

High-intensity interval training, HIT-L

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hospital care after acute CAD event (ICD-10 codes I20.0-I22)
• age 40-80 years
• signed informed consent form

You may not qualify if:

• conditions preventing regular exercise training
• severe/malignant disease (life expectancy \<12 months)

Sponsors & Collaborators

• Kuopio Research Institute of Exercise Medicine: lead
• Social Insurance Institution, Finland: collaborator
• Kuopio University Hospital: collaborator
• University of Eastern Finland: collaborator
• University of Basel: collaborator

Study Sites (1)

Kuopio Research Institute of Exercise Medicine

Kuopio, 70100, Finland

Location

MeSH Terms

Conditions

Angina, Unstable; Myocardial Infarction

Condition Hierarchy (Ancestors)

Angina Pectoris; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Rainer Rauramaa, professor

  Kuopio Research Institute of Exercise Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2014
• First Posted: September 10, 2014
• Study Start: December 1, 2014
• Primary Completion: November 14, 2016
• Study Completion: December 1, 2019
• Last Updated: January 24, 2017

Record last verified: 2015-12

Locations

FI (1)