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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Hasselt University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hasselt University
ClinicalTrials.gov Identifier:
NCT01333839
First received: April 6, 2011
Last updated: April 11, 2011
Last verified: February 2011
  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

Resource links provided by NLM:


Further study details as provided by Hasselt University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333839

Contacts
Contact: Dominique Hansen, PhD 011 309657 ext 0032 dominique.hansen@jassazh.be

Locations
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         
Sponsors and Collaborators
Hasselt University
Investigators
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 October 16, 2014