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Different Endurance Training Protocols in Cardiac Rehabilitation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01493193
First Posted: December 15, 2011
Last Update Posted: August 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University
  Purpose

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.


Condition Intervention Phase
Coronary Artery Disease Other: Endurance training with constant work load Other: Pyramid-Training Other: High-intensity interval training Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Different Endurance Training Protocols on Physical Performance in Cardiac Patients

Further study details as provided by Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 60
Study Start Date: November 2011
Study Completion Date: May 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Endurance training with constant work load Other: Endurance training with constant work load
Endurance training with constant work load(n=15): 31min at 65-75% HRmax
Experimental: Pyramid-Training 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.
Experimental: High-intensity interval training 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

  Eligibility

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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01493193


Locations
Austria
Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
Salzburg, Austria, 5020
Sponsors and Collaborators
Paracelsus Medical University
Investigators
Study Chair: Josef Niebauer, MD, PhD, MBA Paracelsus Medical University
Principal Investigator: Marcus Tschentscher, MSc Paracelsus Medical University
  More Information

Additional Information:
Publications:

Responsible Party: Prof. Josef Niebauer M.D., Ph.D., MBA, Primar, Paracelsus Medical University
ClinicalTrials.gov Identifier: NCT01493193     History of Changes
Other Study ID Numbers: UISM-5
First Submitted: December 13, 2011
First Posted: December 15, 2011
Last Update Posted: August 1, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases