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

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:

  1. acute worsening respiratory symptoms without any other causes, And
  2. Smoking more than 15 pack-years or the history of noxious gas exposure, And
  3. Spirometry reports suggests obstructive ventilatory defect (FEV1/FVC <0.7) or
  4. 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:

  1. Significant fluid retention such as edema, pleural effusion or ascites,
  2. Patients with permanent pacemaker or implantable cardioverter defibrillator ,
  3. 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.

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

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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