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

H

Hasselt University

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Other: exercise training

Study type

Interventional

Funder types

Other

Identifiers

NCT01333839
CABG2011

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Single Blind

30 participants in 3 patient groups

standard exercise intervention
Active Comparator group
Description:
12 weeks of endurance exercise training
Treatment:
Other: exercise training
modified exercise intervention
Active Comparator group
Description:
combined endurance + strength exercise training
Treatment:
Other: exercise training
modified 2 exercise intervention
Active Comparator group
Description:
combined endurance + strength exercise training + oral protein supplements
Treatment:
Other: exercise training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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