Evaluation of the Bone Mineral Density and Muscle Mass in Patients Post Coronary Artery Bypass Graft Surgery With Chronic Kidney Disease

Completed

• Conditions: Coronary Artery Bypass Graft; Chronic Kidney Disease

• Registration Number: NCT01932008
• Lead Sponsor: Far Eastern Memorial Hospital

Brief Summary

The purposes of this study are: (1) to compare the body composition, physical activity, physical function, and quality of life between patients with and without CKD after CABG; and (2) to analyze the relationships among body composition, physical activity, and physical function in this population. It is expected that patients after CABG with CKD have the worse body composition, physical function, and quality of life than patients after CABG without CKD; and patients with higher physical activity levels have the better body composition, physical function, and quality of life.

Detailed Description

It has been reported that cardiac disease and renal disease frequently coexisted. Recently, the term cardiorenal syndrome was used to describe the interaction between heart and kidney. Chronic kidney disease (CKD) has become increasingly recognized as an independent risk factor of cardiovascular disease, and the cardiovascular disease is one of most severe complication in patients with CKD. Previous studies have showed the changes in body composition, physical inactivity, decreased physical function, and poor quality of life existed in patients with either cardiovascular disease or CKD. Patients concomitant with cardiovascular disease and kidney insufficiency were expected to significantly increase physical dysfunction. However, few studies addressed on these alterations in patients after coronary artery bypass grafting (CABG) with CKD were reported.

Study Timeline

• Status Verified: 2012-04
• Study Start: 2012-05
• Primary Completion: 2013-06
• Study Completion: 2013-07
• Study First Submitted: 2013-08-27
• Study First Submitted QC: 2013-08-29
• Last Update Submitted: 2013-08-29
• Study First Posted: 2013-08-30
• Last Update Posted: 2013-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• patients undergoing CABG without valve surgery
• chronic kidney disease(matched group: without CKD)

Exclusion Criteria

1. heart transplantation or redo CABG
2. amputation,
3. cerebrovascular disease or any others disease with limbs dysfunction,
4. lung deficit,
5. cancer,
6. cognitive disorders.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
lean body mass and body fat	The participants were followed at one time points after operation in past 10 years	All the subjects underwent dual-energy x-ray absorptiometry(DEXA) examination for body composition evaluation. The lean body mass and body fat were examined by DEXA.

Secondary Outcome Measures

Name	Time	Method
physical activity	The participants were followed at one time points after operation in past 10 years	The level of physical activity was evaluated by the self-administrated long form of the International Physical Activity Questionnaire, which was permitted by the Bureau of Health Promotion, Department of Health, R.O.C.(Taiwan). It is an instrument that estimates the weekly time spent on the performance of physical activities according to intensity, in different contexts of life (workplace, household tasks, transport and leisure). Reported minutes per week in each category were weighted by a metabolic equivalent (MET; multiples of resting energy expenditure).
physical function	The participants were followed at one time points after operation in past 10 years	The outcome measures of physical function included grip strength, 30-second chair stand test, and six-minute walk test(6MWT).
quality of life	The participants were followed at one time points after operation in past 10 years	QOL was measured using abbreviated version of the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire. The original WHOQOL-BREF comprised 26 questions and included four domains: physical, psychological, social relationships, and environment. The WHOQOL-BREF scale has been adapted for Taiwan and added two questions appropriate for Taiwanese culture.