Training Intensity After Coronary Bypass Grafting

NCT ID: NCT00226733

Last Updated: 2010-05-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2007-03-31

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.

Conditions

Coronary Artery Bypass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Interval exercise training with high intensity

Group Type: EXPERIMENTAL

Exercise training

Intervention Type: BEHAVIORAL

Interval exercise training with high intensity five days per week for four weeks.

B

Exercise training with moderate intensity

Group Type: ACTIVE_COMPARATOR

Exercise training

Intervention Type: BEHAVIORAL

Exercise training with moderate intensity, five days per week for four weeks.

Interventions

Exercise training

Interval exercise training with high intensity five days per week for four weeks.

Intervention Type: BEHAVIORAL

Exercise training

Exercise training with moderate intensity, five days per week for four weeks.

Intervention Type: BEHAVIORAL

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stiftelsen Helse og Rehabilitering

OTHER

Sponsor Role: collaborator

Landsforeningen for hjerte og lungesyke (LHL)

UNKNOWN

Sponsor Role: collaborator

Røros Rehabiliteringssenter

UNKNOWN

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Norwegian University of Science and Technology

Principal Investigators

Stig A Slørdahl, Dr.med

Role: STUDY_CHAIR

NTNU, Institutt for sirkulasjon og bildediagnostikk

Trine T Moholdt, MS

Role: PRINCIPAL_INVESTIGATOR

NTNU, Institutt for sirkulasjo og bildediagnostikk

Locations

Norwegian University of Science and Technology

Trondheim, , Norway

Countries

Norway

Other Identifiers

BypassRoros1

Identifier Type: -

Identifier Source: org_study_id