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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT01127802
Other study ID # 201003017R
Secondary ID
Status Enrolling by invitation
Phase N/A
First received May 20, 2010
Last updated May 20, 2010
Start date January 2010
Est. completion date March 2011

Study information

Verified date May 2010
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Department of Health
Study type Observational

Clinical Trial Summary

The purpose of this study is to explore the changes of functional status, symptoms distress and quality of life in patients undergoing coronary artery bypass graft (CABG) surgery.


Description:

This is an observational cohort study. The participants will be inpatients undergoing elective CABG surgery at one tertiary medical center. Functional status (including activity of daily living, cognitive and nutritional status), symptom distress, and quality of life will be measured at multiple points: pre-surgery, day 1 to 7 post-surgery, before discharge, and 2-4 weeks after discharge. Structured questionnaire will be used to collect demographic and medical characteristics. The Barthel Index, hand-held dynamometer, 6-minute walking test, Mini-Nutritional Assessment (MNA), Mini-Mental State Examination (MMSE), Confusion Assessment Method (CAM), Symptoms Distress Scale, and Short-Form-36 Health Survey (SF-36) will be used to collect functional data and compared for changes. The trajectory of functional status, symptoms distress, and quality of life will be further analyzed. The findings will add to the literature by raising the awareness on changes of functional status, symptoms distress, and quality of life for patients undergoing elective CABG so targeted and timely intervention could be developed and planned.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 50
Est. completion date March 2011
Est. primary completion date March 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 95 Years
Eligibility Inclusion Criteria:

- receive elective coronary artery bypass surgery

- able to communicate in Chinese and Taiwanese

- walk independently or use walker

- length of stay is over 7 days

Exclusion Criteria:

- unable to walk

- mechanical ventilation

- neural or muscle disease to influence ambulation(ex: Parkinson Disease)

- asthma

- severe psychotic disorder that prevents patient from participating in test

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms

  • Coronary Artery Bypass Graft Surgery

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital
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