Ignite Creation Date:
2024-05-06 @ 3:14 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02235753
Status:
TERMINATED
Last Update Posted:
2017-01-24
First Post:
2014-09-03
Brief Title:
High-intensity Exercise After Acute Cardiac Event HITCARE
Sponsor:
Kuopio Research Institute of Exercise Medicine
Organization:
Kuopio Research Institute of Exercise Medicine
Study Overview
Official Title:
High-Intensity Exercise Training in Cardiac Rehabilitation After Acute Coronary Event - Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment was stopped due to lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HITCARE
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 eg 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 Patients 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
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 eg 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 Patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None