- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04885933
The Impact of Sarcopenia on COPD Exacerbation Admission Outcome and Further Exacerbation Risk
May 10, 2021 updated by: Far Eastern Memorial Hospital
Chronic obstructive pulmonary disease (COPD) is more prevalent and has more impact on health status because of progressive air pollution, tobacco smoking and aging society.
The COPD prevalence investigation in 2013 by phone call showed at least 6% of the population with more than 40 years-old in Taiwan.
It also was the 7th ranking of death causes in Taiwan then.
Apart from chronic inflammation in lung and deteriorated lung function, it had extrapulmonary complications, such as cardiovascular problems, osteoporosis and muscle wasting.
The concept of sarcopenia was proposed at first in 1989.
It increases the risk of falls, disability and lowering life quality.
Besides, it increased the mortality risk after admission from acute ward.
Thereafter, sarcopenia is one of COPD co-morbidities, which should have great impacts of COPD.
The studies showed sarcopenia reduced exercise capacities and worsening dyspnea scores.
On the other hand, COPD exacerbation brings significant health burden.
But there is limited data about the effect on sarcopenia on COPD exacerbation.
We conducted a prospective observational study.
We measured skeletal muscle mass and the strength of the used hand grip within 3 days of admission and before discharge.
Mortality and exacerbation in one year are the primary end-points
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
43
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
New Taipei, Taiwan, 220
- Far Eastern Memorial Hospital
-
-
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
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients more than 45 years-old, were admitted due to COPD exacerbation.
Description
Inclusion criteria: Patients more than 45 years-old, were admitted due to COPD exacerbation.
COPD exacerbation criteria:
- acute worsening respiratory symptoms without any other causes, And
- Smoking more than 15 pack-years or the history of noxious gas exposure, And
- Spirometry reports suggests obstructive ventilatory defect (FEV1/FVC <0.7) or
- Attending physicians diagnose as COPD by clinical parameters if spirometry data are not available while enrolling.
Definite COPD exacerbation: fulfill 1、2、3 Probable COPD exacerbation: fulfill 1、2、4
Exclusion criteria:
- Significant fluid retention such as edema, pleural effusion or ascites,
- Patients with permanent pacemaker or implantable cardioverter defibrillator ,
- Morbid obesity with BMI >34
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: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
COPD exacerbation
|
BIA for fat free muscle mass hand grasp strength
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mortality and exacerbations within 1 year of admission
Time Frame: 1 years
|
1 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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 (Actual)
January 31, 2018
Primary Completion (Actual)
January 31, 2019
Study Completion (Actual)
June 21, 2020
Study Registration Dates
First Submitted
May 10, 2021
First Submitted That Met QC Criteria
May 10, 2021
First Posted (Actual)
May 13, 2021
Study Record Updates
Last Update Posted (Actual)
May 13, 2021
Last Update Submitted That Met QC Criteria
May 10, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FEMH-106099-E
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
The data that support the findings of this study are available from the corresponding author, [P.H.W], upon reasonable request
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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