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CompletedNCT02303379Updated Jan 29, 2021

Different Endurance Training Protocols in Cardiac Patients

An interventional study of Continuous Endurance Training and Pyramid Training in Coronary Artery Disease, sponsored by Paracelsus Medical University. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-29.

Sponsored by Paracelsus Medical University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Training Protocol
  • Cardiac Rehabilitation
  • High-Intensity Interval Training
  • Continuous Training
  • Pyramid Training
  • Physical Performance
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 52 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Paracelsus Medical University is the lead sponsor of 33 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Active comparator
    Continuous Endurance training

    Endurance training with constant work load 31min at 65-75% maximal heart rate (HRmax)

    Other: Pyramid Training · Other: High-intensity interval training

  • Experimental
    Pyramid Training

    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.

    Other: Continuous Endurance Training · Other: High-intensity interval training

  • Experimental
    High-intensity intervall training

    HIT: 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 · Other: Pyramid Training

Interventions

  • OtherContinuous Endurance Training

    Endurance training with constant work load 31min at 65-75% Hrmax

  • OtherPyramid Training

    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.

  • OtherHigh-intensity interval training

    HIT: 4x4 min intervals at85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min.

06

What researchers measure

Primary outcomes

  1. Physical work capacity (PWC)

    PWC will be measured by graded exercise testing on cycle ergometer.

    Time frame: 6 weeks or 36 weeks

Secondary outcomes

  1. Heart rate

    Heart rate will be measured by graded exercise testing on cycle ergometer.

    Time frame: 6 weeks or 36 weeks

  2. Blood pressure

    Blood pressure will be measured by graded exercise testing on cycle ergometer.

    Time frame: 6 weeks or 36 weeks

  3. Lactate Thresholds

    Lactate thresholds will be measured by graded exercise testing on cycle ergometer.

    Time frame: 6 weeks or 36 weeks

  4. Metabolical and cellular blood parameter

    Blood will be taken before and after intervention

    Time frame: 6 weeks or 36 weeks

  5. BMI

    BMI will be taken before and after intervention

    Time frame: 6 weeks or 36 weeks

  6. Gene expression

    Gene expression will be taken before and after intervention

    Time frame: 6 weeks or 36 weeks

  7. Quality of Life

    Quality of Life will be taken before and after intervention

    Time frame: 6 weeks or 36 weeks

07

Study locations

1 site
  • Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
    Salzburg, 5020, Austria
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02303379
Lead sponsor
Paracelsus Medical University
Responsible party
Prof. Josef Niebauer M.D., Ph.D., MBA (Head of institute, Paracelsus Medical University) — Principal investigator
First posted
Nov 27, 2014
Start date
Jan 2014
Primary completion
Dec 2018
Completion
Dec 2020
Last update
Jan 29, 2021

Study contacts

Prof. Josef Niebauer, M.D, PhD,MBA
principal investigator · Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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