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

NCT01333839 | Completed

• 1 other identifier: CABG2011
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

CABG surgery; exercise intervention; insulin sensitivity; muscle mass

Outcome Measures

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.

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

Secondary Outcomes (1)

• change in exercise capacity

  2, 12, 54 weeks after surgery

Study Arms (3)

standard exercise intervention

ACTIVE COMPARATOR

12 weeks of endurance exercise training

Other: exercise training

modified exercise intervention

ACTIVE COMPARATOR

combined endurance + strength exercise training

Other: exercise training

modified 2 exercise intervention

ACTIVE COMPARATOR

combined endurance + strength exercise training + oral protein supplements

Other: exercise training

Interventions

exercise training OTHER

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

Also known as: Rehabilitation

modified 2 exercise intervention; modified exercise intervention; standard exercise intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hasselt University: lead

Study Sites (1)

Jessa Hospital

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

Coronary Artery Disease; Insulin Resistance

Interventions

Exercise; Rehabilitation

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Dominique Hansen, PhD

  Jessa Hospital, Hasselt, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 12, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

BE (1)