Different Endurance Training Protocols in Cardiac Rehabilitation

Coronary Artery Disease Clinical Trial

Official title:

Effects of Different Endurance Training Protocols on Physical Performance in Cardiac Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01493193
• Other study ID #: UISM-5
• Status: Completed
• Phase: Phase 4
• First received: December 13, 2011
• Last updated: July 31, 2013
• Start date: November 2011
• Est. completion date: May 2013

Study information

• Verified date: July 2013
• Source: Paracelsus Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Endurance training with constant work load
Endurance training with constant work load(n=15): 31min at 65-75% HRmax
• 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.
• 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

Locations

Country	Name	City	State
Austria	Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University	Salzburg

Sponsors (1)

Lead Sponsor	Collaborator
Paracelsus Medical University

Country where clinical trial is conducted

Austria, 

References & Publications (5)

Flynn KE, Piña 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. — View Citation

Helgerud J, Høydal 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. — View Citation

Niebauer J, Hambrecht R, Velich T, Hauer K, Marburger C, Kälberer B, Weiss C, von Hodenberg E, Schlierf G, Schuler G, Zimmermann R, Kübler 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. — View 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, Piña 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. — View Citation

Wisløff U, Støylen A, Loennechen JP, Bruvold M, Rognmo Ø, Haram PM, Tjønna AE, Helgerud J, Slørdahl SA, Lee SJ, Videm V, Bye A, Smith GL, Najjar SM, Ellingsen Ø, 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. Epub 2007 Jun 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 weeks	No
Secondary	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	6 weeks	No

External Links

•   Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University Salzburg, Austria
•   Salzburg Regional Hospital