NCT02303379

Brief Summary

It is the aim of our study to compare the effects of 6 and/or 2 years of either 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable 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

January 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 27, 2014

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

4.9 years

First QC Date

November 25, 2014

Last Update Submit

January 28, 2021

Conditions

Keywords

Training ProtocolCardiac RehabilitationHigh-Intensity Interval TrainingContinuous TrainingPyramid TrainingPhysical Performance

Outcome Measures

Primary Outcomes (1)

  • Physical work capacity (PWC)

    PWC will be measured by graded exercise testing on cycle ergometer.

    6 weeks or 36 weeks

Secondary Outcomes (7)

  • Heart rate

    6 weeks or 36 weeks

  • Blood pressure

    6 weeks or 36 weeks

  • Lactate Thresholds

    6 weeks or 36 weeks

  • Metabolical and cellular blood parameter

    6 weeks or 36 weeks

  • BMI

    6 weeks or 36 weeks

  • +2 more secondary outcomes

Study Arms (3)

Continuous Endurance training

ACTIVE COMPARATOR

Endurance training with constant work load 31min at 65-75% maximal heart rate (HRmax)

Other: Pyramid TrainingOther: High-intensity interval training

Pyramid Training

EXPERIMENTAL

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 of 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.

Other: Continuous Endurance TrainingOther: High-intensity interval training

High-intensity intervall training

EXPERIMENTAL

HIT: 4x4 min intervals at85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min.

Other: Continuous Endurance TrainingOther: Pyramid Training

Interventions

Endurance training with constant work load 31min at 65-75% Hrmax

High-intensity intervall trainingPyramid Training

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 of 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.

Continuous Endurance trainingHigh-intensity intervall training

HIT: 4x4 min intervals at85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min.

Continuous Endurance trainingPyramid Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute coronary syndrome (STEMI - NONSTEMI)
  • aortocoronary bypass surgery
  • percutaneous coronary intervention (PCI)
  • state after stable coronary heart disease
  • state after heart surgeries
  • state after myo-, endo-, or pericarditis
  • state after heart- or lung-transplantation
  • state after heart failure
  • state after pulmonary hypertension
  • state after peripheral venous disease
  • state after electrophysiological surgery
  • state after implantation of an implantable cardioverter or difibrillator
  • Patients at high risk
  • Patients with cardiac dysrhythmias or sudden death

You may not qualify if:

  • unstable angina pectoris
  • Heart failure (NYHA IV)
  • acute myo-, endo-, or pericarditis or other infections
  • pulmonary-arterial embolism or phlebothrombosis within 6 months
  • hemodynamic instable dysrhythmias
  • hypertrophic cardiomyopathy
  • 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, 5020, Austria

Location

Related Publications (1)

  • Mayr B, Muller EE, Schafer C, Droese S, Schonfelder M, Niebauer J. Exercise-induced changes in miRNA expression in coronary artery disease. Clin Chem Lab Med. 2021 May 12;59(10):1719-1727. doi: 10.1515/cclm-2021-0164. Print 2021 Sep 27.

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Prof. Josef Niebauer, M.D, PhD,MBA

    Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of institute

Study Record Dates

First Submitted

November 25, 2014

First Posted

November 27, 2014

Study Start

January 1, 2014

Primary Completion

December 1, 2018

Study Completion

December 1, 2020

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations