- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00218985
Exercise-training Before Coronary Artery Bypass Graft (CABG)
February 16, 2018 updated by: Norwegian University of Science and Technology
The aim is to evaluate the effect of exercise training upon endothelial function in the mammary artery of patients who are scheduled for CABG, as well as study the functional properties of single cells isolated from a small biopsy of the left ventricle obtained during surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
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
-
-
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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
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Scheduled for CABG both with and without heart failure
Exclusion Criteria:
- Unstable angina
- Unable to walk on a treadmill (except those with heart failure who only will serve as a reference group)
- Participation in another study
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: exercise training
|
Intensity controlled exercise training before the scheduled bypass surgery
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No Intervention: physician's advice
patients follow their physician's advice in regard to physical activity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Cardiovascular function and quality of life
Time Frame: Before and up to 1 year after intervention
|
Before and up to 1 year after intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Structure and function of cardiomyocytes
Time Frame: After the intervention period
|
After the intervention period
|
|
Cardiomyocyte structure and function
Time Frame: after the intervention period
|
after the intervention period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ulrik Wisloff, Ph.D, Norwegian University of Science and Technology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
January 1, 2005
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
September 20, 2005
First Submitted That Met QC Criteria
September 20, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Actual)
February 20, 2018
Last Update Submitted That Met QC Criteria
February 16, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRIM 158-04
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.