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Training Intensity After Coronary Bypass Grafting

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ClinicalTrials.gov Identifier: NCT00226733
Recruitment Status : Terminated
First Posted : September 27, 2005
Last Update Posted : May 18, 2010
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Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Behavioral: Exercise training Phase 2

Detailed Description:

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Training Intensity After Coronary Bypass Grafting
Study Start Date : March 2004
Primary Completion Date : March 2007
Study Completion Date : March 2007

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A
Interval exercise training with high intensity
Behavioral: Exercise training
Interval exercise training with high intensity five days per week for four weeks.
Active Comparator: B
Exercise training with moderate intensity
Behavioral: Exercise training
Exercise training with moderate intensity, five days per week for four weeks.

Outcome Measures

Primary Outcome Measures :
  1. Oxygen Consumption

Secondary Outcome Measures :
  1. Quality of life
  2. Pulse
  3. Blodverdier
  4. Ekkokardiografiske parametre

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226733

Norwegian University of Science and Technology
Trondheim, Norway, 7489
Sponsors and Collaborators
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
More Information

Responsible Party: Trine Moholdt, Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00226733     History of Changes
Other Study ID Numbers: BypassRoros1
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: May 18, 2010
Last Verified: April 2008

Keywords provided by Norwegian University of Science and Technology:
Coronary Artery Bypass (E04.928.220.520.220)
Exercise Test [E01.370.370.380.250]
Echocardiography [E01.370.370.380.220]
Quality of Life [K01.752.400.750]