Unstable Angina PectorisHITCARENCT02235753
High-intensity Exercise After Acute Cardiac Event (HITCARE)
A study testing High-intensity aerobic interval training, short interval and High-intensity aerobic interval training, long interval in people with Unstable Angina Pectoris and Acute Myocardial Infarction, run by Kuopio Research Institute of Exercise Medicine at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Unstable Angina Pectoris, Acute Myocardial Infarction, Recurrent Myocardial Infarction
- What is being tested?
- High-intensity aerobic interval training, short interval and High-intensity aerobic interval training, long interval
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteFinland
- Study dates
- Dec 2014to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hospital care after acute CAD event (ICD-10 codes I20.0-I22)
- age 40-80 years
- signed informed consent form
Who cannot join
- conditions preventing regular exercise training
- severe/malignant disease (life expectancy <12 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- 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.
- Patient's experiences and interpretation of HIT exercise as well as different social processes during rehabilitation explain the cost-effectiveness of the rehabilitation.
- Patient groups who will or will not benefit of HIT interventions can be identified and predicted.
- Being tested
- High-intensity aerobic interval training, short interval, High-intensity aerobic interval training, long interval
- Medical subject headings
- Angina, Unstable, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity aerobic interval training, short intervalBehavioural
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 aerobic interval training, long intervalBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training, HIT-S | Experimental | High-intensity aerobic interval training, short interval (HIT-S) Receives: Behavioral: High-intensity aerobic interval training, short interval |
| High-intensity interval training, HIT-L | Experimental | High-intensity aerobic interval training, long interval (HIT-L) Receives: Behavioral: High-intensity aerobic interval training, long interval |
| Usual care | No intervention | control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiorespiratory fitness as assessed by peak oxygen uptake (VO2peak)
Measured: Baseline, 6 and 12 months
Secondary outcomes (5)
Incremental health care cost/quality-adjusted life-year-relation
Measured: 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).
Measured: 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).
Measured: Baseline, 6 and 12 months
Utilization of health care resources
Measured: Baseline, 6 and 12 months
Change in health-related quality of life
Measured: Baseline, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startDec 2014
- Primary completion14 Nov 2016
- Study completionDec 2019 (estimated)
Why it stopped: Recruitment was stopped due to lack of funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unstable Angina PectorisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio Research Institute of Exercise Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Social Insurance Institution, Finland, Kuopio University Hospital, University of Eastern Finland, University of Basel
- Responsible party
- Principal investigator, Rainer Rauramaa, Kuopio Research Institute of Exercise Medicine
- Investigators
- Rainer Rauramaa, professor, Principal investigator, Kuopio Research Institute of Exercise Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235753
- Sponsor's protocol ID
- 1072011
- Acronym
- HITCARE
- Status last verified
- Dec 2015
- First submitted
- 3 Sep 2014
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Intensity Exercise Training in Cardiac Rehabilitation After Acute Coronary Event - Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02235753
- Acronym / sponsor ID
- HITCARE / 1072011
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was stopped due to lack of funding.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Kuopio Research Institute of Exercise MedicineUniversity, hospital or other
- Collaborators
- Social Insurance Institution, Finland, Kuopio University Hospital, University of Eastern Finland, University of Basel
- Study start
- Dec 2014
- Primary completion
- 14 Nov 2016 (actual)
- Study completion
- Dec 2019 (estimated)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- Patient's experiences and interpretation of HIT exercise as well as different social processes during rehabilitation explain the cost-effectiveness of the rehabilitation.
- Patient groups who will or will not benefit of HIT interventions can be identified and predicted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training, HIT-S | Experimental | Behavioral: High-intensity aerobic interval training, short intervalHigh-intensity aerobic interval training, short interval (HIT-S) |
| High-intensity interval training, HIT-L | Experimental | Behavioral: High-intensity aerobic interval training, long intervalHigh-intensity aerobic interval training, long interval (HIT-L) |
| Usual care | No intervention | –control group |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- hospital care after acute CAD event (ICD-10 codes I20.0-I22)
- age 40-80 years
- signed informed consent form
Key exclusion criteria (2 listed)
- conditions preventing regular exercise training
- severe/malignant disease (life expectancy <12 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity aerobic interval training, short intervalThe 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. | Behavioural | High-intensity interval training, HIT-S |
| High-intensity aerobic interval training, long intervalThe 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. | Behavioural | High-intensity interval training, HIT-L |
Primary outcome
Change in cardiorespiratory fitness as assessed by peak oxygen uptake (VO2peak)
Time frame: Baseline, 6 and 12 months
5 secondary outcomes
Incremental health care cost/quality-adjusted life-year-relation
Time frame: Baseline, 6 and 12 months
Social processes explaining adherence and motivation to exercise rehabilitation
Time frame: Baseline, 6 and 12 months
Total costs of the use of health care services
Time frame: Baseline, 6 and 12 months
Utilization of health care resources
Time frame: Baseline, 6 and 12 months
Change in health-related quality of life
Time frame: Baseline, 6 and 12 months
Results and safety
The study was stopped early (reason given: Recruitment was stopped due to lack of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Rauramaa, professor principal investigator
Kuopio Research Institute of Exercise Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity aerobic interval training, short interval and High-intensity aerobic interval training, long interval in people with Unstable Angina Pectoris and Acute Myocardial Infarction, run by Kuopio Research Institute of Exercise Medicine at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment was stopped due to lack of funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiorespiratory fitness as assessed by peak oxygen uptake (VO2peak) (time frame: Baseline, 6 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.