Impact of Coronary Artery Bypass Graft (CABG) Surgery on Skeletal Muscle Mass and Insulin Sensitivity, Followed by Exercise Intervention
- Conditions
- Coronary Artery Disease
- Interventions
- Other: exercise training
- Registration Number
- NCT01333839
- Lead Sponsor
- Hasselt University
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Elective CABG surgery
- Willing to participate in 12-week exercise intervention
- Complicated surgery
- Severe complications during first days after CABG surgery
- Orthopedic limitations that interfere with proper exercise intervention participation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description modified exercise intervention exercise training combined endurance + strength exercise training modified 2 exercise intervention exercise training combined endurance + strength exercise training + oral protein supplements standard exercise intervention exercise training 12 weeks of endurance exercise training
- Primary Outcome Measures
Name Time Method change in muscle mass and insulin sensitivity pre-operative, 1, 2, 3 days, and 2, 12, 54 weeks after surgery 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.
- Secondary Outcome Measures
Name Time Method change in exercise capacity 2, 12, 54 weeks after surgery Baseline exercise capacity will be assessed at 2 weeks after surgery. Afterwards, the change in this parameters will be assessed at various predefined timepoints.
Trial Locations
- Locations (1)
Jessa Hospital
🇧🇪Hasselt, Belgium