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CompletedNCT01333839Updated Mar 18, 2015

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

An interventional study of exercise training in Coronary Artery Disease, sponsored by Hasselt University. Completed at 1 site in Belgium. Per ClinicalTrials.gov, last updated 2015-03-18.

Sponsored by Hasselt University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Sex
All
01

Study summary

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.

Read the detailed 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • CABG surgery
  • exercise intervention
  • insulin sensitivity
  • muscle mass
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 30 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Hasselt University is the lead sponsor of 195 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Complicated surgery
  • Severe complications during first days after CABG surgery
  • Orthopedic limitations that interfere with proper exercise intervention participation
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    standard exercise intervention

    12 weeks of endurance exercise training

    Other: exercise training

  • Active comparator
    modified exercise intervention

    combined endurance + strength exercise training

    Other: exercise training

  • Active comparator
    modified 2 exercise intervention

    combined endurance + strength exercise training + oral protein supplements

    Other: exercise training

Interventions

  • Otherexercise training

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

    Also known as: Rehabilitation

06

What researchers measure

Primary outcomes

  1. change in muscle mass and insulin sensitivity

    Baseline insulin sensitivity and muscle mass will be assessed ahead of surgery. Afterwards, the change in these parameters will be assessed at various predefined timepoints.

    Time frame: pre-operative, 1, 2, 3 days, and 2, 12, 54 weeks after surgery

Secondary outcomes

  1. change in exercise capacity

    Baseline exercise capacity will be assessed at 2 weeks after surgery. Afterwards, the change in this parameters will be assessed at various predefined timepoints.

    Time frame: 2, 12, 54 weeks after surgery

07

Study locations

1 site
  • Jessa Hospital
    Hasselt, 3500, Belgium
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01333839
Lead sponsor
Hasselt University
Responsible party
Dominique Hansen (Associate Professor, Hasselt University) — Principal investigator
First posted
Apr 12, 2011
Start date
Feb 2011
Primary completion
Feb 2015
Completion
Mar 2015
Last update
Mar 18, 2015

Study contacts

Dominique Hansen, PhD
principal investigator · Jessa Hospital, Hasselt, Belgium

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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