Clinical trial NCT02303379: Different Endurance Training Protocols in Cardiac Patients
Official title: Effects of Different Endurance Training Protocols on Physical Performance in Cardiac Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Training Protocol
Cardiac Rehabilitation
High-Intensity Interval Training
Continuous Training
Pyramid Training
Physical Performance
Lead sponsor: Paracelsus Medical University
Sponsor class: OTHER
First posted: 2014-11-27
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Physical work capacity (PWC)
timeFrame: 6 weeks or 36 weeks
Secondary outcomes:
measure: Heart rate
timeFrame: 6 weeks or 36 weeks
measure: Blood pressure
timeFrame: 6 weeks or 36 weeks
measure: Lactate Thresholds
timeFrame: 6 weeks or 36 weeks
measure: Metabolical and cellular blood parameter
timeFrame: 6 weeks or 36 weeks
measure: BMI
timeFrame: 6 weeks or 36 weeks
measure: Gene expression
timeFrame: 6 weeks or 36 weeks
measure: Quality of Life
timeFrame: 6 weeks or 36 weeks
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
Study officials:
affiliation: Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
name: Prof. Josef Niebauer, M.D, PhD,MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.