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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06280443
Other study ID # CE22407B
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 25, 2022
Est. completion date September 30, 2032

Study information

Verified date April 2024
Source Taichung Veterans General Hospital
Contact Pin-Kuei Fu
Phone 04-23592525
Email fpk113@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Inclusion criteria A)Outpatients with COPD (chronic obstructive pulmonary disease) or ILD (interstitial lung disease) from department of Chest medicine in Taichung Veterans General Hospital, judged by the doctor that they do not need hospitalization or emergent treatment. B) Patients who agree to provide the ID card number to the research team for usage as a link to the National Health Insurance research database and Health bank to explore the continuity of care and the use of medical resources


Description:

This study is a prospective, multi-center, and non-invasive cohort study. All participants are diagnosed with Asthma, COPD and ILD. We use SARC-Calf questionnaire, Frailty questionnaire and Grip strength as a tool for prescreen. According to the 2019 Asian Sarcopenia Consensus, participants are examined by SARC-Calf questionnaire, grip strength test and a physical performance test, including sit-stand test, short physical performance battery (SPPB), gait speed test and six-minute walk test. Bioelectrical impedance analysis (BIA) and Dual-energy X-ray absorptiometry (DXA) are applied to all participants by to analyze body composition. Participants are further classified into no Sarcopenia group, Sarcopenia group, and severe Sarcopenia group to derive the prevalence.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date September 30, 2032
Est. primary completion date October 13, 2024
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: 1. Outpatients with COPD (chronic obstructive pulmonary disease) or ILD (interstitial lung disease) from department of Chest medicine in Taichung Veterans General Hospital, judged by the doctor that they do not need hospitalization or emergent treatment. 2. Those who meet the conditions for frailty diagnosis after assessment by the Frailty Scale 3. Patients who agree to provide the ID card number to the research team for usage as a link to the National Health Insurance research database and Health bank to explore the continuity of care and the use of medical resources 4. Age>=20 Exclusion Criteria: 1. Patients who refuse to sign the consent form 2. Patients who are bed ridden or unable to walk due to physical disabilities 3. Patients with terminal cancer or human acquired immunodeficiency syndrome 4. Patients with edema (pitting edema +2)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan Taichung Veterans General Hospital Taichung

Sponsors (1)

Lead Sponsor Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary sarcopenia rate The proportion of sarcopenia diagnosis in patients with chronic lung diseases 1 year
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