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

Chronic Kidney Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932008
• Other study ID #: FEMH-IRB-100110-F
• Status: Completed
• Phase: N/A
• First received: August 27, 2013
• Last updated: August 29, 2013
• Start date: May 2012
• Est. completion date: July 2013

Study information

• Verified date: April 2012
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Republic of China: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Coronary Artery Bypass Graft
• Kidney Diseases
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lean body mass and body fat	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.	The participants were followed at one time points after operation in past 10 years	Yes
Secondary	physical activity	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).	The participants were followed at one time points after operation in past 10 years	Yes
Secondary	physical function	The outcome measures of physical function included grip strength, 30-second chair stand test, and six-minute walk test(6MWT).	The participants were followed at one time points after operation in past 10 years	Yes
Secondary	quality of life	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.	The participants were followed at one time points after operation in past 10 years	Yes