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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
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Bypass
 Behavioral: Exercise training
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Training Intensity After Coronary Bypass Grafting

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Oxygen Consumption

Secondary Outcome Measures:
  • Quality of life
  • Pulse
  • Blodverdier
  • Ekkokardiografiske parametre

Estimated Enrollment: 60
Study Start Date: March 2004
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226733

Locations
Norway
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
Investigators
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

No publications provided

Responsible Party: Trine Moholdt, Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00226733     History of Changes
Other Study ID Numbers: BypassRoros1
Study First Received: September 12, 2005
Last Updated: May 17, 2010
Health Authority: Norway: Norwegian Social Science Data Services

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]

ClinicalTrials.gov processed this record on June 18, 2013