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Different Endurance Training Protocols in Cardiac Rehabilitation

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ClinicalTrials.gov Identifier: NCT01493193
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : August 1, 2013
Sponsor:
Information provided by (Responsible Party):
Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University

December 13, 2011
December 15, 2011
August 1, 2013
November 2011
February 2013   (Final data collection date for primary outcome measure)
Individual maximum power output in watt (Pmax) [ Time Frame: 6 weeks ]
Change of individual maximum power output in watt (Pmax) on a bicycle ergometer after the training intervention of controlled physical activity within 6 weeks
Same as current
Complete list of historical versions of study NCT01493193 on ClinicalTrials.gov Archive Site
Power output in watt at lactate threshold of 2 and 4 mmol/l [ Time Frame: 6 weeks ]
Change of power output in watt at lactate thresholds at 2 and 4 mmol/l
Same as current
Not Provided
Not Provided
 
Different Endurance Training Protocols in Cardiac Rehabilitation
Effects of Different Endurance Training Protocols on Physical Performance in Cardiac Patients

It is the aim of the study to compare the effects of 6 weeks of either high-intensity interval training (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.

The three exercise arms (isocaloric) are composed as follows:

Endurance training (n=15): 31min at 65-75% HRmax; HIT (n=15): 4x4min intervals at 85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min; Pyramids (n=15): 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 at 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% HRpeak.

Primary Outcome: Individual maximum power output in watt (Pmax). Secondary Outcome: Change of power output in watt at lactate thresholds at 2 and 4 mmol/l.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Coronary Artery Disease
  • Other: Endurance training with constant work load
    Endurance training with constant work load(n=15): 31min at 65-75% HRmax
  • Other: Pyramid-Training
    Pyramid-Training (n=15): 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 at 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 (n=15): 4x4min intervals at 85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min
  • Active Comparator: Endurance training with constant work load
    Intervention: Other: Endurance training with constant work load
  • Experimental: Pyramid-Training
    Intervention: Other: Pyramid-Training
  • Experimental: High-intensity interval training
    Intervention: Other: High-intensity interval training

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
45
May 2013
February 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

At least one of the following diagnoses within the previous 3 months:

  • acute coronary syndrome (STEMI)
  • acute coronary syndrome (NSTEMI)
  • aortocoronary bypass surgery
  • PCI
  • stable coronary heart disease

Exclusion Criteria:

  • Unstable angina pectoris
  • Heart failure (NYHA IV)
  • Acute endomyocarditis or other acute infections
  • Pulmonary artery embolism or phlebothrombosis within the previous 6 months
  • Hemodynamically unstable arrhythmia
  • Hypertrophic cardiomyopathy
  • participation in another study within the previous 6 months
  • Medical conditions which prevent patients from complying with the exercise program
Sexes Eligible for Study: All
25 Years to 85 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT01493193
UISM-5
No
Not Provided
Not Provided
Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University
Paracelsus Medical University
Not Provided
Study Chair: Josef Niebauer, MD, PhD, MBA Paracelsus Medical University
Principal Investigator: Marcus Tschentscher, MSc Paracelsus Medical University
Paracelsus Medical University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP