Overview

This trial is active, not recruiting.

Condition coronary artery disease
Treatments continuous endurance training, pyramid training, high-intensity interval training
Phase phase 4
Sponsor Paracelsus Medical University
Start date January 2014
End date December 2016
Trial size 52 participants
Trial identifier NCT02303379, UISM-8

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Endurance training with constant work load 31min at 65-75% maximal heart rate (HRmax)
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.
high-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.
(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.
continuous endurance training
Endurance training with constant work load 31min at 65-75% Hrmax
high-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.
(Experimental)
HIT: 4x4 min intervals at85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min.
continuous endurance training
Endurance training with constant work load 31min at 65-75% Hrmax
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.

Primary Outcomes

Measure
Physical work capacity (PWC)
time frame: 6 weeks or 36 weeks

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Effects of Different Endurance Training Protocols on Physical Performance in Cardiac Patients
Principal investigator Prof. Josef Niebauer, M.D, PhD,MBA
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Paracelsus Medical University.