Different Endurance Training Protocols in Cardiac Rehabilitation

NCT ID: NCT01493193

Last Updated: 2013-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endurance training with constant work load

Group Type ACTIVE_COMPARATOR

Endurance training with constant work load

Intervention Type OTHER

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

Pyramid-Training

Group Type EXPERIMENTAL

Pyramid-Training

Intervention Type OTHER

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

Group Type EXPERIMENTAL

High-intensity interval training

Intervention Type OTHER

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

Interventions

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Endurance training with constant work load

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

Intervention Type 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.

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paracelsus Medical University

OTHER

Sponsor Role lead

Responsible Party

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Prof. Josef Niebauer M.D., Ph.D., MBA

Primar

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Josef Niebauer, MD, PhD, MBA

Role: STUDY_CHAIR

Paracelsus Medical University

Marcus Tschentscher, MSc

Role: PRINCIPAL_INVESTIGATOR

Paracelsus Medical University

Locations

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Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University

Salzburg, Salzburg, Austria

Site Status

Countries

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Austria

References

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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.

Reference Type BACKGROUND
PMID: 19351942 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9355890 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19351941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17414804 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17548726 (View on PubMed)

Related Links

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http://www.salk.at/sportmedizin.html

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

http://www.salk.at

Salzburg Regional Hospital

Other Identifiers

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UISM-5

Identifier Type: -

Identifier Source: org_study_id