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Different Endurance Training Protocols in Cardiac Patients

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Continuous Endurance Training
Pyramid Training
High-intensity interval training
Sponsored by
Paracelsus Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Training Protocol, Cardiac Rehabilitation, High-Intensity Interval Training, Continuous Training, Pyramid Training, Physical Performance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Continuous Endurance training

Pyramid Training

High-intensity intervall training

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

Physical work capacity (PWC)
PWC will be measured by graded exercise testing on cycle ergometer.

Secondary Outcome Measures

Heart rate
Heart rate will be measured by graded exercise testing on cycle ergometer.
Blood pressure
Blood pressure will be measured by graded exercise testing on cycle ergometer.
Lactate Thresholds
Lactate thresholds will be measured by graded exercise testing on cycle ergometer.
Metabolical and cellular blood parameter
Blood will be taken before and after intervention
BMI
BMI will be taken before and after intervention
Gene expression
Gene expression will be taken before and after intervention
Quality of Life
Quality of Life will be taken before and after intervention

Full Information

First Posted
November 25, 2014
Last Updated
January 28, 2021
Sponsor
Paracelsus Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02303379
Brief Title
Different Endurance Training Protocols in Cardiac Patients
Official Title
Effects of Different Endurance Training Protocols on Physical Performance in Cardiac Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Paracelsus Medical University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Training Protocol, Cardiac Rehabilitation, High-Intensity Interval Training, Continuous Training, Pyramid Training, Physical Performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continuous Endurance training
Arm Type
Active Comparator
Arm Description
Endurance training with constant work load 31min at 65-75% maximal heart rate (HRmax)
Arm Title
Pyramid Training
Arm Type
Experimental
Arm Description
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.
Arm Title
High-intensity intervall training
Arm Type
Experimental
Arm Description
HIT: 4x4 min intervals at85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min.
Intervention Type
Other
Intervention Name(s)
Continuous Endurance Training
Intervention Description
Endurance training with constant work load 31min at 65-75% Hrmax
Intervention Type
Other
Intervention Name(s)
Pyramid Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
High-intensity interval training
Intervention Description
HIT: 4x4 min intervals at85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min.
Primary Outcome Measure Information:
Title
Physical work capacity (PWC)
Description
PWC will be measured by graded exercise testing on cycle ergometer.
Time Frame
6 weeks or 36 weeks
Secondary Outcome Measure Information:
Title
Heart rate
Description
Heart rate will be measured by graded exercise testing on cycle ergometer.
Time Frame
6 weeks or 36 weeks
Title
Blood pressure
Description
Blood pressure will be measured by graded exercise testing on cycle ergometer.
Time Frame
6 weeks or 36 weeks
Title
Lactate Thresholds
Description
Lactate thresholds will be measured by graded exercise testing on cycle ergometer.
Time Frame
6 weeks or 36 weeks
Title
Metabolical and cellular blood parameter
Description
Blood will be taken before and after intervention
Time Frame
6 weeks or 36 weeks
Title
BMI
Description
BMI will be taken before and after intervention
Time Frame
6 weeks or 36 weeks
Title
Gene expression
Description
Gene expression will be taken before and after intervention
Time Frame
6 weeks or 36 weeks
Title
Quality of Life
Description
Quality of Life will be taken before and after intervention
Time Frame
6 weeks or 36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Josef Niebauer, M.D, PhD,MBA
Organizational Affiliation
Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
City
Salzburg
ZIP/Postal Code
5020
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
33977686
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.
Results Reference
derived
Links:
URL
http://www.pmu.ac.at
Description
Paracelsus Medical University Salzburg, Austria
URL
http://www.salk.at/sportmedizin.html
Description
Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
URL
http://www.salk.at/
Description
Salzburg Regional Hospital

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Different Endurance Training Protocols in Cardiac Patients

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