- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01493193
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Salzburg, Austria, 5020
- Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Endurance training with constant work load
|
Endurance training with constant work load(n=15): 31min at 65-75% HRmax
|
|
Experimental: 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
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Josef Niebauer, MD, PhD, MBA, Paracelsus Medical University
- Principal Investigator: Marcus Tschentscher, MSc, Paracelsus Medical University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UISM-5
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