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Trial record 61 of 45988 for:    intensity

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

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ClinicalTrials.gov Identifier: NCT02235753
Recruitment Status : Terminated (Recruitment was stopped due to lack of funding.)
First Posted : September 10, 2014
Last Update Posted : January 24, 2017
Sponsor:
Collaborators:
Social Insurance Institution, Finland
Kuopio University Hospital
University of Eastern Finland
University of Basel
Information provided by (Responsible Party):
Rainer Rauramaa, Kuopio Research Institute of Exercise Medicine

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.

Condition or disease Intervention/treatment Phase
Unstable Angina Pectoris Acute Myocardial Infarction Recurrent Myocardial Infarction Behavioral: High-intensity aerobic interval training, short interval Behavioral: High-intensity aerobic interval training, long interval Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: High-Intensity Exercise Training in Cardiac Rehabilitation After Acute Coronary Event - Randomized Controlled Trial
Study Start Date : December 2014
Actual Primary Completion Date : November 14, 2016
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Change in cardiorespiratory fitness as assessed by peak oxygen uptake (VO2peak) [ Time Frame: Baseline, 6 and 12 months ]

Secondary Outcome Measures :
  1. Incremental health care cost/quality-adjusted life-year-relation [ Time Frame: Baseline, 6 and 12 months ]
  2. Social processes explaining adherence and motivation to exercise rehabilitation [ Time Frame: Baseline, 6 and 12 months ]
    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).

  3. Total costs of the use of health care services [ Time Frame: Baseline, 6 and 12 months ]
    The use of total health services will be assessed by diary, questionnaire and from registers (national, hospital district and domicile health center).

  4. Utilization of health care resources [ Time Frame: Baseline, 6 and 12 months ]
  5. Change in health-related quality of life [ Time Frame: Baseline, 6 and 12 months ]

Other Outcome Measures:
  1. Change in ergospirometer variables [ Time Frame: Baseline, 6 and 12 months ]
  2. Change in muscular performance [ Time Frame: Baseline, 6 and 12 months ]
  3. Change in daily energy expenditure [ Time Frame: Baseline, 6 and 12 months ]
  4. Sleeping time [ Time Frame: Baseline, 6 and 12 months ]
  5. Sitting time [ Time Frame: Baseline, 6 and 12 months ]
  6. Dietary habits [ Time Frame: Baseline, 6 and 12 months ]
    Measured by food frequency questionnaire

  7. Change in chest pain symptoms, exercise induced angina or ischemia [ Time Frame: Baseline, 6 and 12 months ]
    Composite measure based on anamnesis and ECG

  8. Change in antianginal and other medication [ Time Frame: Baseline, 6 and 12 months ]
  9. Hospitalization due to cardiovascular causes [ Time Frame: Baseline, 6 and 12 months ]
  10. Change in vascular risk factors [ Time Frame: Baseline, 6 and 12 months ]
  11. Progression of peripheral atherosclerosis [ Time Frame: Baseline, 6 and 12 months ]
  12. Change in cognitive function [ Time Frame: Baseline and 12 months ]
  13. Change in depressive symptoms [ Time Frame: Baseline, 6 and 12 months ]
  14. Intervention related adverse events [ Time Frame: Throughout the intervention phase ]
  15. Change in myocardial blood flow capacity and left ventricular function [ Time Frame: Baseline and 12 months ]
  16. Change in myocardial blood flow at rest and during adenosine infusion [ Time Frame: Baseline and 12 months ]
  17. Change in myocardial blood flow reserve [ Time Frame: Baseline and 12 months ]
  18. Change in left ventricular ejection fraction [ Time Frame: Baseline and 12 months ]
  19. Change in left ventricular longitudinal peak systolic strain [ Time Frame: Baseline and 12 months ]
  20. Change in left mitral annular diastolic tissue velocity [ Time Frame: Baseline and 12 months ]
  21. Change in autonomic nervous system control of cardiac function [ Time Frame: Baseline and 12 months ]
  22. Change in body composition [ Time Frame: Baseline, 6 and 12 months ]
    Measured by bioimpedance

  23. Change in anthropometric measures [ Time Frame: Baseline, 6 and 12 months ]

    Measured by body weight, body height, waist circumference, and hip circumference.

    Body mass index and waist to hip ratio will be calculated.


  24. All-cause death [ Time Frame: Baseline, 6 and 12 months; annual follow-up up to 60 months ]
  25. Cardiovascular death [ Time Frame: Baseline, 6 and 12 months; annual follow-up up to 60 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235753


Locations
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Finland
Kuopio Research Institute of Exercise Medicine
Kuopio, Finland, 70100
Sponsors and Collaborators
Kuopio Research Institute of Exercise Medicine
Social Insurance Institution, Finland
Kuopio University Hospital
University of Eastern Finland
University of Basel
Investigators
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Principal Investigator: Rainer Rauramaa, professor Kuopio Research Institute of Exercise Medicine

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Responsible Party: Rainer Rauramaa, Professor, Kuopio Research Institute of Exercise Medicine
ClinicalTrials.gov Identifier: NCT02235753     History of Changes
Other Study ID Numbers: 1072011
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: December 2015
Additional relevant MeSH terms:
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Myocardial Infarction
Angina Pectoris
Angina, Unstable
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms