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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01591642
Other study ID # FEMH-IRB-099087-E
Secondary ID
Status Completed
Phase N/A
First received April 27, 2012
Last updated May 2, 2012
Start date January 2011
Est. completion date December 2011

Study information

Verified date October 2010
Source Far Eastern Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority China:Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 315
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- patients undergoing CABG without valve surgery

Exclusion Criteria:

1. systemic disease, such as liver, renal disease,

2. amputation,

3. cerebrovascular disease or any others disease with limbs dysfunction,

4. lung deficit,

5. cancer,

6. cognitive disorders.

Study Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


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 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 fitness 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 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
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