Training Intensity After Coronary Bypass Grafting

This study has been terminated.
Sponsor:
Collaborators:
Stiftelsen Helse og Rehabilitering
Landsforeningen for hjerte og lungesyke (LHL)
Røros Rehabiliteringssenter
St. Olavs Hospital
Information provided by:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00226733
First received: September 12, 2005
Last updated: May 17, 2010
Last verified: April 2008

September 12, 2005
May 17, 2010
March 2004
March 2007   (final data collection date for primary outcome measure)
Oxygen Consumption
Oxygen Consumption (G06.535.723)
Complete list of historical versions of study NCT00226733 on ClinicalTrials.gov Archive Site
  • Quality of life
  • Pulse
  • Blodverdier
  • Ekkokardiografiske parametre
  • Quality of life (K01.752.400.750)
  • Pulse [E01.370.370.380.650]
  • Blodverdier
  • Ekkokardiografiske parametre
Not Provided
Not Provided
 
Training Intensity After Coronary Bypass Grafting
Training Intensity After Coronary Bypass Grafting

The purpose of this study is to investigate the effect of high and moderate intensity exercise training after coronary bypass surgery. The subjects are randomised to training at either 60-70% or 85-95% of their maximal capacity daily for four weeks. Primary outcome measure is change in maximal aerobic capacity, measured as change in maximal oxygen consumption, after the training period. Secondary outcome measures are change in quality of life, heart rate variability, ultrasound measures of the heart and blood variables, including endothelian markers.

The exercise part of cardiac rehabilitation today is often composed of low to moderate intensity training. Several studies have found interval training with high intensity to be more effective in improving physical capacity in healthy subjects and also in different patient populations. We therefore wish to compare high intensity interval training with moderate intensity training in patients operated with coronary bypass surgery. Maximal oxygen consumption is shown to be the best indicator of how many years you life, both in healthy persons and in cardiac patients.

The subjects in this study is attending a four week rehabilitation program at an residential institution in Norway. They are randomised to do either a moderate or a high intensity aerobic training session each day.

The hypothesis in advance, was that high intensity interval training lead to a greater improvement in maximal oxygen consumption than training with moderate intensity. We also hypothesised that there would be no difference between the two groups after 6 months, since then the patients had to administer their own exercise training.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Artery Bypass
  • Behavioral: Exercise training
    Interval exercise training with high intensity five days per week for four weeks.
  • Behavioral: Exercise training
    Exercise training with moderate intensity, five days per week for four weeks.
  • Experimental: A
    Interval exercise training with high intensity
    Intervention: Behavioral: Exercise training
  • Active Comparator: B
    Exercise training with moderate intensity
    Intervention: Behavioral: Exercise training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
60
March 2007
March 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Coronary Artery Grafting (4-12 weeks ago)

Exclusion Criteria:

  • Not able to exercise on a treadmill
  • Left ventricle ejection fraction < 30%
  • hemodynamic significant valve deficit (> NYHA classification II)
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00226733
BypassRoros1
No
Trine Moholdt, Norwegian University of Science and Technology
Norwegian University of Science and Technology
  • Stiftelsen Helse og Rehabilitering
  • Landsforeningen for hjerte og lungesyke (LHL)
  • Røros Rehabiliteringssenter
  • St. Olavs Hospital
Study Chair: Stig A Slørdahl, Dr.med NTNU, Institutt for sirkulasjon og bildediagnostikk
Principal Investigator: Trine T Moholdt, MS NTNU, Institutt for sirkulasjo og bildediagnostikk
Norwegian University of Science and Technology
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP