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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
exercise training
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring CABG surgery, exercise intervention, insulin sensitivity, muscle mass

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Jessa Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

standard exercise intervention

modified exercise intervention

modified 2 exercise intervention

Arm Description

12 weeks of endurance exercise training

combined endurance + strength exercise training

combined endurance + strength exercise training + oral protein supplements

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
April 6, 2011
Last Updated
March 17, 2015
Sponsor
Hasselt University
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1. Study Identification

Unique Protocol Identification Number
NCT01333839
Brief Title
Impact of Coronary Artery Bypass Graft (CABG) Surgery on Skeletal Muscle Mass and Insulin Sensitivity, Followed by Exercise Intervention
Official Title
Impact of CABG Surgery and Subsequent Exercise Intervention on Insulin Sensitivity and Muscle Mass: a Cluster Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hasselt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CABG surgery, exercise intervention, insulin sensitivity, muscle mass

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard exercise intervention
Arm Type
Active Comparator
Arm Description
12 weeks of endurance exercise training
Arm Title
modified exercise intervention
Arm Type
Active Comparator
Arm Description
combined endurance + strength exercise training
Arm Title
modified 2 exercise intervention
Arm Type
Active Comparator
Arm Description
combined endurance + strength exercise training + oral protein supplements
Intervention Type
Other
Intervention Name(s)
exercise training
Other Intervention Name(s)
Rehabilitation
Intervention Description
endurance exercise training: 40 min of exercise at 65% of VO2peak, 3 days/week
Primary Outcome Measure Information:
Title
change in muscle mass and insulin sensitivity
Description
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 Outcome Measure Information:
Title
change in exercise capacity
Description
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Hansen, PhD
Organizational Affiliation
Jessa Hospital, Hasselt, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jessa Hospital
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium

12. IPD Sharing Statement

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

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