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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02303379
Other study ID # UISM-8
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2014
Est. completion date December 2020

Study information

Verified date January 2021
Source Paracelsus Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date December 2020
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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.
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.

Locations

Country Name City State
Austria Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University Salzburg

Sponsors (1)

Lead Sponsor Collaborator
Paracelsus Medical University

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical work capacity (PWC) PWC will be measured by graded exercise testing on cycle ergometer. 6 weeks or 36 weeks
Secondary Heart rate Heart rate will be measured by graded exercise testing on cycle ergometer. 6 weeks or 36 weeks
Secondary Blood pressure Blood pressure will be measured by graded exercise testing on cycle ergometer. 6 weeks or 36 weeks
Secondary Lactate Thresholds Lactate thresholds will be measured by graded exercise testing on cycle ergometer. 6 weeks or 36 weeks
Secondary Metabolical and cellular blood parameter Blood will be taken before and after intervention 6 weeks or 36 weeks
Secondary BMI BMI will be taken before and after intervention 6 weeks or 36 weeks
Secondary Gene expression Gene expression will be taken before and after intervention 6 weeks or 36 weeks
Secondary Quality of Life Quality of Life will be taken before and after intervention 6 weeks or 36 weeks
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