Different Endurance Training Protocols in Cardiac Rehabilitation
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Endurance training with constant work load
Pyramid-Training
High-intensity interval training
Sponsored by

About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility 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
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
Endurance training with constant work load
Pyramid-Training
High-intensity interval training
Arm Description
Outcomes
Primary Outcome Measures
Individual maximum power output in watt (Pmax)
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
Change of power output in watt at lactate thresholds at 2 and 4 mmol/l
Full Information
NCT ID
NCT01493193
First Posted
December 13, 2011
Last Updated
July 31, 2013
Sponsor
Paracelsus Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01493193
Brief Title
Different Endurance Training Protocols in Cardiac Rehabilitation
Official Title
Effects of Different Endurance Training Protocols on Physical Performance in Cardiac Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
May 2013 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endurance training with constant work load
Arm Type
Active Comparator
Arm Title
Pyramid-Training
Arm Type
Experimental
Arm Title
High-intensity interval training
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Endurance training with constant work load
Intervention Description
Endurance training with constant work load(n=15): 31min at 65-75% HRmax
Intervention Type
Other
Intervention Name(s)
Pyramid-Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
High-intensity interval training
Intervention Description
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
Primary Outcome Measure Information:
Title
Individual maximum power output in watt (Pmax)
Description
Change of individual maximum power output in watt (Pmax) on a bicycle ergometer after the training intervention of controlled physical activity within 6 weeks
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Power output in watt at lactate threshold of 2 and 4 mmol/l
Description
Change of power output in watt at lactate thresholds at 2 and 4 mmol/l
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josef Niebauer, MD, PhD, MBA
Organizational Affiliation
Paracelsus Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marcus Tschentscher, MSc
Organizational Affiliation
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
19351942
Citation
Flynn KE, Pina IL, Whellan DJ, Lin L, Blumenthal JA, Ellis SJ, Fine LJ, Howlett JG, Keteyian SJ, Kitzman DW, Kraus WE, Miller NH, Schulman KA, Spertus JA, O'Connor CM, Weinfurt KP; HF-ACTION Investigators. Effects of exercise training on health status in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1451-9. doi: 10.1001/jama.2009.457. Erratum In: JAMA. 2009 Dec 2;302(21):2322.
Results Reference
background
PubMed Identifier
9355890
Citation
Niebauer J, Hambrecht R, Velich T, Hauer K, Marburger C, Kalberer B, Weiss C, von Hodenberg E, Schlierf G, Schuler G, Zimmermann R, Kubler W. Attenuated progression of coronary artery disease after 6 years of multifactorial risk intervention: role of physical exercise. Circulation. 1997 Oct 21;96(8):2534-41. doi: 10.1161/01.cir.96.8.2534.
Results Reference
background
PubMed Identifier
19351941
Citation
O'Connor CM, Whellan DJ, Lee KL, Keteyian SJ, Cooper LS, Ellis SJ, Leifer ES, Kraus WE, Kitzman DW, Blumenthal JA, Rendall DS, Miller NH, Fleg JL, Schulman KA, McKelvie RS, Zannad F, Pina IL; HF-ACTION Investigators. Efficacy and safety of exercise training in patients with chronic heart failure: HF-ACTION randomized controlled trial. JAMA. 2009 Apr 8;301(14):1439-50. doi: 10.1001/jama.2009.454.
Results Reference
background
PubMed Identifier
17414804
Citation
Helgerud J, Hoydal K, Wang E, Karlsen T, Berg P, Bjerkaas M, Simonsen T, Helgesen C, Hjorth N, Bach R, Hoff J. Aerobic high-intensity intervals improve VO2max more than moderate training. Med Sci Sports Exerc. 2007 Apr;39(4):665-71. doi: 10.1249/mss.0b013e3180304570.
Results Reference
background
PubMed Identifier
17548726
Citation
Wisloff U, Stoylen A, Loennechen JP, Bruvold M, Rognmo O, Haram PM, Tjonna AE, Helgerud J, Slordahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen O, Skjaerpe T. Superior cardiovascular effect of aerobic interval training versus moderate continuous training in heart failure patients: a randomized study. Circulation. 2007 Jun 19;115(24):3086-94. doi: 10.1161/CIRCULATIONAHA.106.675041. Epub 2007 Jun 4.
Results Reference
background
Links:
URL
http://www.salk.at/sportmedizin.html
Description
Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University Salzburg, Austria
URL
http://www.salk.at
Description
Salzburg Regional Hospital
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Different Endurance Training Protocols in Cardiac Rehabilitation
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