- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01932008
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
Status
Completed
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:
- heart transplantation or redo CABG
- amputation,
- cerebrovascular disease or any others disease with limbs dysfunction,
- lung deficit,
- cancer,
- 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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FEMH-IRB-100110-F
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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