Impact of Coronary Artery Bypass Graft (CABG) Surgery on Skeletal Muscle Mass and Insulin Sensitivity, Followed by Exercise Intervention

NCT ID: NCT01333839

Last Updated: 2015-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2015-03-31

Brief Summary

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In this study, the investigators want to examine the impact of coronary artery bypass graft (CABG) surgery on skeletal muscle mass, muscle metabolism, and insulin sensitivity in 90 subjects. In extent, the impact of a subsequent exercise intervention will be examined, with a follow-up up to 12 months after surgery.

Detailed Description

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90 subjects undergoing elective CABG surgery will be included. These subjects are free from orthopedic limitations, will have no severe complications during surgery, and are willing to participate in a 12-week exercise training intervention.

At baseline (before surgery), following parameters will be assessed: blood parameters (glycemic control, lipid profile, anabolic/catabolic hormones, inflammatory markers), body composition (by dual x-ray absorptiometry), handgrip strength, and general subject features (medication, gender, age, etc.).

The first three days after surgery, blood samples will be collected for the analysis of glycemic control, lipid profile, anabolic/catabolic hormones, inflammatory markers.

Next, at the start of exercise intervention, after 6 and 12 weeks of exercise training, and after a 12-month follow-up, following parameters will be assessed: blood parameters (glycemic control, lipid profile, anabolic/catabolic hormones, inflammatory markers), body composition (by dual x-ray absorptiometry), handgrip strength, maximal exercise capacity (by ergospirometry testing), physical activity (by questionnaire), and quality of life ( by questionnaire).

At 12 months of follow-up, cardiovascular mortality and morbidity (re-occurrence of angina, acute myocardial infarction, need for surgery, death) will be assessed.

When initiating exercise intervention, subjects will randomly (n=30 in each group) be assigned to 12 weeks of standard exercise intervention (endurance exercise training), modified exercise intervention (endurance exercise training + strength training), or modified exercise intervention (endurance exercise training + strength training + oral protein supplements).

This will be a cluster randomized clinical trial. Investigators executing the measurements will be blinded for treatment allocation.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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standard exercise intervention

12 weeks of endurance exercise training

Group Type ACTIVE_COMPARATOR

exercise training

Intervention Type OTHER

endurance exercise training: 40 min of exercise at 65% of VO2peak, 3 days/week

modified exercise intervention

combined endurance + strength exercise training

Group Type ACTIVE_COMPARATOR

exercise training

Intervention Type OTHER

endurance exercise training: 40 min of exercise at 65% of VO2peak, 3 days/week

modified 2 exercise intervention

combined endurance + strength exercise training + oral protein supplements

Group Type ACTIVE_COMPARATOR

exercise training

Intervention Type OTHER

endurance exercise training: 40 min of exercise at 65% of VO2peak, 3 days/week

Interventions

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exercise training

endurance exercise training: 40 min of exercise at 65% of VO2peak, 3 days/week

Intervention Type OTHER

Other Intervention Names

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Rehabilitation

Eligibility Criteria

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Inclusion Criteria

* Elective CABG surgery
* Willing to participate in 12-week exercise intervention

Exclusion Criteria

* Complicated surgery
* Severe complications during first days after CABG surgery
* Orthopedic limitations that interfere with proper exercise intervention participation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Dominique Hansen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dominique Hansen, PhD

Role: PRINCIPAL_INVESTIGATOR

Jessa Hospital, Hasselt, Belgium

Locations

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Jessa Hospital

Hasselt, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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CABG2011

Identifier Type: -

Identifier Source: org_study_id

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