- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01591642
Physical Activity, Functional Fitness and Quality of Life After Coronary Artery Bypass Grafting
May 2, 2012 updated by: Far Eastern Memorial Hospital
The main purposes of this study are: (1) to investigate the difference of the physical fitness, and quality of life (QOL) among different physical activity levels in post-coronary artery bypass graft (CABG) patients; (2) to analyze the relationships between physical activity and physical fitness and QOL in this population.
The investigators predict physical activity and physical fitness remain limited in patients after CABG, and patients with higher physical activity levels will have higher QOL and physical fitness.
Study Overview
Status
Completed
Conditions
Detailed Description
Heart diseases continue as the top 3 causes of death in Taiwan in recent ten years.
Coronary artery disease (CAD) is the most prevalent fatal heart disease.
Coronary artery bypass graft surgery (CABG) is now one of the most common procedures to treat CAD.
It was reported that CABG intervention could prolong the life.
However, outcomes of CABG have historically been measured in terms of mortality and recurrence of symptoms or complications.There is ample evidence to demonstrate the effect and benefit of cardiac rehabilitation in QOL and function activity in patients post CABG.
However, the participation rate of postoperative cardiac rehabilitation is low, especially in women.Little research has been done to examine the physical activity, physical performance, and QOL in this population outside the cardiac rehabilitation setting.
Study Type
Observational
Enrollment (Actual)
315
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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
Inclusion Criteria:
- patients undergoing CABG without valve surgery
Exclusion Criteria:
- systemic disease, such as liver, renal disease,
- 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
What is the study measuring?
Primary 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
physical fitness
Time Frame: The participants were followed at one time points after operation in past 10 years
|
Physical fitness The outcome measures of physical fitness included body mass index(BMI), waist circumference(WC), 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
|
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
January 1, 2011
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
April 27, 2012
First Submitted That Met QC Criteria
May 2, 2012
First Posted (Estimate)
May 4, 2012
Study Record Updates
Last Update Posted (Estimate)
May 4, 2012
Last Update Submitted That Met QC Criteria
May 2, 2012
Last Verified
October 1, 2010
More Information
Terms related to this study
Other Study ID Numbers
- FEMH-IRB-099087-E
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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