Training Intensity After Coronary Bypass Grafting

Coronary Artery Bypass Clinical Trial

Official title:

Training Intensity After Coronary Bypass Grafting

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00226733
• Other study ID #: BypassRoros1
• Status: Terminated
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: May 17, 2010
• Start date: March 2004
• Est. completion date: March 2007

Study information

• Verified date: April 2008
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Bypass

Intervention

Behavioral:
• Exercise training
Interval exercise training with high intensity five days per week for four weeks.
• Exercise training
Exercise training with moderate intensity, five days per week for four weeks.

Locations

Country	Name	City	State
Norway	Norwegian University of Science and Technology	Trondheim

Sponsors (5)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Landsforeningen for hjerte og lungesyke (LHL), Røros Rehabiliteringssenter, St. Olavs Hospital, Stiftelsen Helse og Rehabilitering

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen Consumption
Secondary	Quality of life
Secondary	Pulse
Secondary	Blodverdier
Secondary	Ekkokardiografiske parametre