Training Intensity After Coronary Bypass Grafting

May 17, 2010 updated by: Norwegian University of Science and Technology
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7489
        • Norwegian University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Behavioral: Exercise training
Exercise training with moderate intensity, five days per week for four weeks.
Active Comparator: B
Exercise training with moderate intensity
Behavioral: Exercise training
Interval exercise training with high intensity five days per week for four weeks.
Behavioral: Exercise training
Exercise training with moderate intensity, five days per week for four weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Oxygen Consumption

Secondary Outcome Measures

Outcome Measure
Quality of life
Pulse
Blodverdier
Ekkokardiografiske parametre

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital
Stiftelsen Helse og Rehabilitering
Landsforeningen for hjerte og lungesyke (LHL)
Røros Rehabiliteringssenter

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 26, 2005

First Posted (Estimate)

September 27, 2005

Study Record Updates

Last Update Posted (Estimate)

May 18, 2010

Last Update Submitted That Met QC Criteria

May 17, 2010

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BypassRoros1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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