NCT01493193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

August 1, 2013

Status Verified

July 1, 2013

Enrollment Period

1.3 years

First QC Date

December 13, 2011

Last Update Submit

July 31, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Power output in watt at lactate threshold of 2 and 4 mmol/l

    6 weeks

Study Arms (3)

Endurance training with constant work load

ACTIVE COMPARATOR
Other: Endurance training with constant work load

Pyramid-Training

EXPERIMENTAL
Other: Pyramid-Training

High-intensity interval training

EXPERIMENTAL
Other: High-intensity interval training

Interventions

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

Endurance training with constant work load

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.

Pyramid-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

High-intensity interval training

Eligibility Criteria

Age25 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University

Salzburg, Salzburg, 5020, Austria

Location

Related Publications (5)

  • 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.

    PMID: 19351942BACKGROUND
  • 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.

    PMID: 9355890BACKGROUND
  • 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.

    PMID: 19351941BACKGROUND
  • 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.

    PMID: 17414804BACKGROUND
  • 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.

    PMID: 17548726BACKGROUND

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Endurance TrainingHigh-Intensity Interval Training

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Josef Niebauer, MD, PhD, MBA

    Paracelsus Medical University

    STUDY CHAIR
  • Marcus Tschentscher, MSc

    Paracelsus Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primar

Study Record Dates

First Submitted

December 13, 2011

First Posted

December 15, 2011

Study Start

November 1, 2011

Primary Completion

February 1, 2013

Study Completion

May 1, 2013

Last Updated

August 1, 2013

Record last verified: 2013-07

Locations