Clinical trial NCT00226733: Training Intensity After Coronary Bypass Grafting
Official title: Training Intensity After Coronary Bypass Grafting
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Coronary Artery Bypass
Keywords: 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]
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Stiftelsen Helse og Rehabilitering
name: Landsforeningen for hjerte og lungesyke (LHL)
name: Røros Rehabiliteringssenter
name: St. Olavs Hospital
First posted: 2005-09-27
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Oxygen Consumption
Secondary outcomes:
measure: Quality of life
measure: Pulse
measure: Blodverdier
measure: Ekkokardiografiske parametre
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology
Study officials:
affiliation: NTNU, Institutt for sirkulasjon og bildediagnostikk
name: Stig A Slørdahl, Dr.med
role: STUDY_CHAIR
affiliation: NTNU, Institutt for sirkulasjo og bildediagnostikk
name: Trine T Moholdt, MS
role: PRINCIPAL_INVESTIGATOR
References: