Different Endurance Training Protocols in Cardiac Rehabilitation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Josef Niebauer M.D., Ph.D., MBA, Paracelsus Medical University
ClinicalTrials.gov Identifier:
NCT01493193
First received: December 13, 2011
Last updated: July 31, 2013
Last verified: July 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Different Endurance Training Protocols on Physical Performance in Cardiac Patients

Resource links provided by NLM:


Further study details as provided by Paracelsus Medical University:

Primary Outcome Measures:
  • Individual maximum power output in watt (Pmax) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   25 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: December 13, 2011
Last Updated: July 31, 2013
Health Authority: Austria: Ethikkommission

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

ClinicalTrials.gov processed this record on April 17, 2014