Different Endurance Training Protocols in Cardiac Patients

January 28, 2021 updated by: Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Continuous Endurance training
Endurance training with constant work load 31min at 65-75% maximal heart rate (HRmax)
Other: 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: 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: 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: 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.
Other: Continuous Endurance Training
Endurance training with constant work load 31min at 65-75% Hrmax
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: 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
Endurance training with constant work load 31min at 65-75% Hrmax

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical work capacity (PWC)
Time Frame: 6 weeks or 36 weeks
PWC will be measured by graded exercise testing on cycle ergometer.
6 weeks or 36 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: 6 weeks or 36 weeks
Heart rate will be measured by graded exercise testing on cycle ergometer.
6 weeks or 36 weeks
Blood pressure
Time Frame: 6 weeks or 36 weeks
Blood pressure will be measured by graded exercise testing on cycle ergometer.
6 weeks or 36 weeks
Lactate Thresholds
Time Frame: 6 weeks or 36 weeks
Lactate thresholds will be measured by graded exercise testing on cycle ergometer.
6 weeks or 36 weeks
Metabolical and cellular blood parameter
Time Frame: 6 weeks or 36 weeks
Blood will be taken before and after intervention
6 weeks or 36 weeks
BMI
Time Frame: 6 weeks or 36 weeks
BMI will be taken before and after intervention
6 weeks or 36 weeks
Gene expression
Time Frame: 6 weeks or 36 weeks
Gene expression will be taken before and after intervention
6 weeks or 36 weeks
Quality of Life
Time Frame: 6 weeks or 36 weeks
Quality of Life will be taken before and after intervention
6 weeks or 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paracelsus Medical University

Investigators

  • Principal Investigator: Prof. Josef Niebauer, M.D, PhD,MBA, Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

November 25, 2014

First Submitted That Met QC Criteria

November 25, 2014

First Posted (Estimate)

November 27, 2014

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 28, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UISM-8

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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