SarcopeniaNCT06280443
Sarcopenia in Chronic Lung Diseases
An observational study of Sarcopenia and COPD, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sarcopenia, COPD, Asthma
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Nov 2022to 30 Sep 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * Baseline demographic characteristic, health behavior and exercise habits are collected by questionnaires.The main disease diagnosis, medication, clinical assessment questionnaire or biochemical examination and radiological examination results in outpatient visit are collected. * According to the 2019 Asian Sarcopenia Consensus, participants are examined by SARC-Calf questionnaire, grip strength test, frailty index and a physical performance test,including sit-stand test, short physical performance battery (SPPB), gait speed test and six-minute walk test. Afterward, bioelectrical impedance analysis (BIA) are applied to all participants by to analyze body composition. Participants are classified into Sarcopenia group and severe Sarcopenia group.
Who may be able to join
- 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.
- Those who meet the conditions for frailty diagnosis after assessment by the Frailty Scale
- 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
- Age>=20
Who cannot join
- Patients who refuse to sign the consent form
- Patients who are bed ridden or unable to walk due to physical disabilities
- Patients with terminal cancer or human acquired immunodeficiency syndrome
- Patients with edema (pitting edema +2)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 40705
Pin-Kuei Fu, MD, PhD, 886-4-23592525 ext. 3213, yetquen@gmail.com
About this study
Official title: Epidemiological Study of Sarcopenia in Patients With Chronic Lung Diseases: A Prospective Registry Cohort Study
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.
- 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
Read the detailed 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.
- Conditions
- Sarcopenia, COPD, Asthma, ILD
- Medical subject headings
- Sarcopenia, Pulmonary Disease, Chronic Obstructive, Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
sarcopenia rate
The proportion of sarcopenia diagnosis in patients with chronic lung diseases
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start25 Nov 2022
- Primary completion13 Oct 2024 (estimated)
- Study completion30 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pin-Kuei Fu, MD, PhD, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280443
- Sponsor's protocol ID
- CE22407B
- Status last verified
- Apr 2024
- First submitted
- 20 Feb 2024
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of Sarcopenia in Patients With Chronic Lung Diseases: A Prospective Registry Cohort Study
- ClinicalTrials.gov ID
- NCT06280443
- Acronym / sponsor ID
- CE22407B
- Conditions
- Sarcopenia, COPD, Asthma, ILD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 13 Oct 2024 (estimated)
- Study completion
- 30 Sep 2032 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * Baseline demographic characteristic, health behavior and exercise habits are collected by questionnaires.The main disease diagnosis, medication, clinical assessment questionnaire or biochemical examination and radiological examination results in outpatient visit are collected. * According to the 2019 Asian Sarcopenia Consensus, participants are examined by SARC-Calf questionnaire, grip strength test, frailty index and a physical performance test,including sit-stand test, short physical performance battery (SPPB), gait speed test and six-minute walk test. Afterward, bioelectrical impedance analysis (BIA) are applied to all participants by to analyze body composition. Participants are classified into Sarcopenia group and severe Sarcopenia group.
Key inclusion criteria (4 listed)
- 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.
- Those who meet the conditions for frailty diagnosis after assessment by the Frailty Scale
- 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
- Age>=20
Key exclusion criteria (4 listed)
- Patients who refuse to sign the consent form
- Patients who are bed ridden or unable to walk due to physical disabilities
- Patients with terminal cancer or human acquired immunodeficiency syndrome
- Patients with edema (pitting edema +2)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sarcopenia rate
Time frame: 1 year
The proportion of sarcopenia diagnosis in patients with chronic lung diseases
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and COPD, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pin-Kuei Fu (04-23592525 ext. 6536, fpk113@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sarcopenia rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.