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

August 29, 2013 updated by: Far Eastern Memorial Hospital
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.

Study Overview

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 Type

Observational

Enrollment (Actual)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

All patients who underwent CABG at the Department of Cardiovascular Center at Far-Eastern Memorial Hospital since January 2000 were selected for recruitment to this study.Thirty male patients after CABG with CKD and 30 matched controls were recruited (ages between 40-75 years old).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lean body mass and body fat
Time Frame: 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.
The participants were followed at one time points after operation in past 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
physical activity
Time Frame: 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).
The participants were followed at one time points after operation in past 10 years
physical function
Time Frame: 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).
The participants were followed at one time points after operation in past 10 years
quality of life
Time Frame: 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.
The participants were followed at one time points after operation in past 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

August 27, 2013

First Submitted That Met QC Criteria

August 29, 2013

First Posted (Estimate)

August 30, 2013

Study Record Updates

Last Update Posted (Estimate)

August 30, 2013

Last Update Submitted That Met QC Criteria

August 29, 2013

Last Verified

April 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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