Coronary Artery DiseaseNCT02303379
Different Endurance Training Protocols in Cardiac Patients
A study testing Continuous Endurance Training, Pyramid Training and High-intensity interval training in people with Coronary Artery Disease, run by Paracelsus Medical University at 1 site in Austria.
Trial summary
It is the aim of our study to compare the effects of 6 and/or 2 years of either HIT (carried out at correctly assessed 85-95% of maximal heart rate), pyramid, or continuous endurance training, on changes of physical exercise capacity in cardiac patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Continuous Endurance Training, Pyramid Training and High-intensity interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2014to Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute coronary syndrome (STEMI - NONSTEMI)
- aortocoronary bypass surgery
- percutaneous coronary intervention (PCI)
- state after stable coronary heart disease
- state after heart surgeries
- state after myo-, endo-, or pericarditis
Show all 14Show fewer
- state after heart- or lung-transplantation
- state after heart failure
- state after pulmonary hypertension
- state after peripheral venous disease
- state after electrophysiological surgery
- state after implantation of an implantable cardioverter or difibrillator
- Patients at high risk
- Patients with cardiac dysrhythmias or sudden death
Who cannot join
- unstable angina pectoris
- Heart failure (NYHA IV)
- acute myo-, endo-, or pericarditis or other infections
- pulmonary-arterial embolism or phlebothrombosis within 6 months
- hemodynamic instable dysrhythmias
- hypertrophic cardiomyopathy
- medical conditions which prevent patients from complying with the exercise program
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
Salzburg, 5020
About this study
Official title: Effects of Different Endurance Training Protocols on Physical Performance in Cardiac Patients
It is the aim of our study to compare the effects of 6 and/or 2 years of either HIT (carried out at correctly assessed 85-95% of maximal heart rate), pyramid, or continuous endurance training, on changes of physical exercise capacity in cardiac patients.
Read the detailed description
The three exercise arms (isocaloric) are composed as follows:
Endurance training: 31 min at 65-75% HRmax, making it a total of 25min; HIT: 4x4min intervals at 85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25 min; Pyramid: One pyramid consists of 8 one-minute blocks. Those are grouped starting with one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85% HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards with one block of 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75% HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax, making it a total of 28min.
All protocols are initiated by 5min of warm-up and end with 5min of cool-down, both at 60-70% HRmax.
Primary Outcome: Individual maximum power output in watt (Pmax). Secondary Outcome: Change of power output in watt at lactate tresholds at 2 and 4mmol/l.
- Conditions
- Coronary Artery Disease
- Being tested
- Continuous Endurance Training, Pyramid Training, High-intensity interval training
- Keywords
- Training Protocol, Cardiac Rehabilitation, High-Intensity Interval Training, Continuous Training, Pyramid Training, Physical Performance
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Endurance TrainingOther
Endurance training with constant work load 31min at 65-75% Hrmax
Pyramid TrainingOther
One pyramid consists of 8 one-minute blocks. Those are grouped starting with one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85% HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards with one block of 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75% HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax, making it a total of 28min.
High-intensity interval trainingOther
HIT: 4x4 min intervals at85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Endurance training | Active comparator | Endurance training with constant work load 31min at 65-75% maximal heart rate (HRmax) Receives: Other: Pyramid Training; Other: High-intensity interval training |
| Pyramid Training | Experimental | One pyramid consists of 8 one-minute blocks. Those are grouped starting with one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85% HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards with one block of 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75% HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax, making it a total of 28min. Receives: Other: Continuous Endurance Training; Other: High-intensity interval training |
| High-intensity intervall training | Experimental | HIT: 4x4 min intervals at85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min. Receives: Other: Continuous Endurance Training; Other: Pyramid Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical work capacity (PWC)
PWC will be measured by graded exercise testing on cycle ergometer.
Measured: 6 weeks or 36 weeks
Secondary outcomes (7)
Heart rate
Heart rate will be measured by graded exercise testing on cycle ergometer.
Measured: 6 weeks or 36 weeks
Blood pressure
Blood pressure will be measured by graded exercise testing on cycle ergometer.
Measured: 6 weeks or 36 weeks
Lactate Thresholds
Lactate thresholds will be measured by graded exercise testing on cycle ergometer.
Measured: 6 weeks or 36 weeks
Metabolical and cellular blood parameter
Blood will be taken before and after intervention
Measured: 6 weeks or 36 weeks
BMI
BMI will be taken before and after intervention
Measured: 6 weeks or 36 weeks
Gene expression
Gene expression will be taken before and after intervention
Measured: 6 weeks or 36 weeks
Quality of Life
Quality of Life will be taken before and after intervention
Measured: 6 weeks or 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2018
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paracelsus Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University
- Investigators
- Prof. Josef Niebauer, M.D, PhD,MBA, Principal investigator, Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02303379
- Sponsor's protocol ID
- UISM-8
- Status last verified
- Jan 2021
- First submitted
- 25 Nov 2014
- Last updated
- 29 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Mayr B, Muller EE, Schafer C, Droese S, Schonfelder M, Niebauer J. Exercise-induced changes in miRNA expression in coronary artery disease. Clin Chem Lab Med. 2021 May 12;59(10):1719-1727. doi: 10.1515/cclm-2021-0164. Print 2021 Sep 27.
PubMed 33977686
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Endurance Training Protocols on Physical Performance in Cardiac Patients
- ClinicalTrials.gov ID
- NCT02303379
- Acronym / sponsor ID
- UISM-8
- Conditions
- Coronary Artery Disease
- Keywords
- Training Protocol, Cardiac Rehabilitation, High-Intensity Interval Training, Continuous Training, Pyramid Training, Physical Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Paracelsus Medical UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 27 Nov 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.
It is the aim of our study to compare the effects of 6 and/or 2 years of either HIT (carried out at correctly assessed 85-95% of maximal heart rate), pyramid, or continuous endurance training, on changes of physical exercise capacity in cardiac patients.
Detailed description
The three exercise arms (isocaloric) are composed as follows:
Endurance training: 31 min at 65-75% HRmax, making it a total of 25min; HIT: 4x4min intervals at 85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25 min; Pyramid: One pyramid consists of 8 one-minute blocks. Those are grouped starting with one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85% HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards with one block of 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75% HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax, making it a total of 28min.
All protocols are initiated by 5min of warm-up and end with 5min of cool-down, both at 60-70% HRmax.
Primary Outcome: Individual maximum power output in watt (Pmax). Secondary Outcome: Change of power output in watt at lactate tresholds at 2 and 4mmol/l.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous Endurance training | Active comparator | Other: Pyramid Training, Other: High-intensity interval trainingEndurance training with constant work load 31min at 65-75% maximal heart rate (HRmax) |
| Pyramid Training | Experimental | Other: Continuous Endurance Training, Other: High-intensity interval trainingOne pyramid consists of 8 one-minute blocks. Those are grouped starting with one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85% HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards with one block of 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75% HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax, making it a total of 28min. |
| High-intensity intervall training | Experimental | Other: Continuous Endurance Training, Other: Pyramid TrainingHIT: 4x4 min intervals at85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- acute coronary syndrome (STEMI - NONSTEMI)
- aortocoronary bypass surgery
- percutaneous coronary intervention (PCI)
- state after stable coronary heart disease
- state after heart surgeries
Key exclusion criteria (7 listed)
- unstable angina pectoris
- Heart failure (NYHA IV)
- acute myo-, endo-, or pericarditis or other infections
- pulmonary-arterial embolism or phlebothrombosis within 6 months
- hemodynamic instable dysrhythmias
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 |
|---|---|---|
| Continuous Endurance TrainingEndurance training with constant work load 31min at 65-75% Hrmax | Other | High-intensity intervall training, Pyramid Training |
| Pyramid TrainingOne pyramid consists of 8 one-minute blocks. Those are grouped starting with one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85% HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards with one block of 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75% HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax, making it a total of 28min. | Other | Continuous Endurance training, High-intensity intervall training |
| High-intensity interval trainingHIT: 4x4 min intervals at85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min. | Other | Continuous Endurance training, Pyramid Training |
Primary outcome
Physical work capacity (PWC)
Time frame: 6 weeks or 36 weeks
PWC will be measured by graded exercise testing on cycle ergometer.
7 secondary outcomes
Heart rate
Time frame: 6 weeks or 36 weeks
Blood pressure
Time frame: 6 weeks or 36 weeks
Lactate Thresholds
Time frame: 6 weeks or 36 weeks
Metabolical and cellular blood parameter
Time frame: 6 weeks or 36 weeks
BMI
Time frame: 6 weeks or 36 weeks
Gene expression
Time frame: 6 weeks or 36 weeks
Quality of Life
Time frame: 6 weeks or 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.
- Derived from this study: PubMed 33977686Mayr B, Muller EE, Schafer C, Droese S, Schonfelder M, Niebauer J. Exercise-induced changes in miRNA expression in coronary artery disease. Clin Chem Lab Med. 2021 May 12;59(10):1719-1727. doi: 10.1515/cclm-2021-0164. Print 2021 Sep 27.
- Paracelsus Medical University Salzburg, AustriaLink provided by the sponsor.
- Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical UniversityLink provided by the sponsor.
- Salzburg Regional HospitalLink provided by the sponsor.
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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.
Prof. Josef Niebauer, M.D, PhD,MBA principal investigator
Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous Endurance Training, Pyramid Training and High-intensity interval training in people with Coronary Artery Disease, run by Paracelsus Medical University at 1 site in Austria.
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 14 inclusion and 7 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: finished, as of the sponsor's last update on 29 Jan 2021. 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 Austria. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physical work capacity (PWC) (time frame: 6 weeks or 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02303379, which also lists 1 linked publication.
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 29 Jan 2021.