Impact of Coronary Artery Bypass Graft (CABG) Surgery on Skeletal Muscle Mass and Insulin Sensitivity, Followed by Exercise Intervention
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Coronary Artery Disease |
Other: exercise training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Impact of CABG Surgery and Subsequent Exercise Intervention on Insulin Sensitivity and Muscle Mass: a Cluster Randomized Trial |
- change in muscle mass and insulin sensitivity [ Time Frame: pre-operative, 1, 2, 3 days, and 2, 12, 54 weeks after surgery ] [ Designated as safety issue: Yes ]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.
- change in exercise capacity [ Time Frame: 2, 12, 54 weeks after surgery ] [ Designated as safety issue: No ]Baseline exercise capacity will be assessed at 2 weeks after surgery. Afterwards, the change in this parameters will be assessed at various predefined timepoints.
| Estimated Enrollment: | 90 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: standard exercise intervention
12 weeks of endurance exercise training
|
Other: exercise training
endurance exercise training: 40 min of exercise at 65% of VO2peak, 3 days/week
Other Name: Rehabilitation
|
|
Active Comparator: modified exercise intervention
combined endurance + strength exercise training
|
Other: exercise training
endurance exercise training: 40 min of exercise at 65% of VO2peak, 3 days/week
Other Name: Rehabilitation
|
|
Active Comparator: modified 2 exercise intervention
combined endurance + strength exercise training + oral protein supplements
|
Other: exercise training
endurance exercise training: 40 min of exercise at 65% of VO2peak, 3 days/week
Other Name: Rehabilitation
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Dominique Hansen, PhD | 011 309657 ext 0032 | dominique.hansen@jassazh.be |
| Belgium | |
| Jessa Hospital | Recruiting |
| Hasselt, Belgium, 3500 | |
| Contact: Paul Dendale, MD, PhD 011 307842 ext 0032 paul.dendale@jessazh.be | |
| Principal Investigator: Dominique Hansen, PhD | |
| Principal Investigator: | Dominique Hansen, PhD | Jessa Hospital, Hasselt, Belgium |
More Information
No publications provided
| Responsible Party: | Hansen Dominique, PhD, Jessa Hospital/Hasselt University |
| ClinicalTrials.gov Identifier: | NCT01333839 History of Changes |
| Other Study ID Numbers: | CABG2011 |
| Study First Received: | April 6, 2011 |
| Last Updated: | April 11, 2011 |
| Health Authority: | Belgium: Ethics Committee |
Keywords provided by Hasselt University:
|
CABG surgery exercise intervention insulin sensitivity muscle mass |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Insulin Resistance Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
Vascular Diseases Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013