COPDNCT06223139
Association Between Handgrip Strength and Small Airway Disease in Patients with Stable Chronic Obstructive Pulmonary Disease
An observational study of COPD, run by Thammasat University at 1 site in Thailand.
Trial summary
The goal of this observational study is to investigate the correlation between handgrip strength and small airway disease among patients with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Handgrip strength
- How many people
- 64 participants
- Where
- 1 siteThailand
- Study dates
- 1 Mar 2023to 31 May 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients aged 40 years or older who are confirmed diagnosis by spirometry (post-bronchodilator FEV1/FVC <0.7) and smoking history 10 pack-years or more.
Who may be able to join
- COPD patients aged 40 years or older
- Confirmed diagnosis by spirometry (post-bronchodilator FEV1/FVC <0.7)
- Smoking history 10 pack-years or more
Who cannot join
- COPD exacerbation within 3 months
- Inability to perform handgrip strength test or impulse oscillometry
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Thammasat University Faculty of Medicine
Pathum Thani, Changwat Pathum Thani, 12120
About this study
The goal of this observational study is to investigate the correlation between handgrip strength and small airway disease among patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:
- Is handgrip strength correlated with small airway disease in COPD patients? Participants will perform handgrip strength test and impulse oscillometry (IOS).
Read the detailed description
This is a cross-sectional study in COPD patients. COPD patients aged 40 years or older were included. Handgrip strength test and impulse oscillometry will be tested in each patient. Handgrip strength will be measured using a hand dynamometer. Small airway disease will be assessed using IOS.
- Conditions
- COPD
- Being tested
- Handgrip strength
- Keywords
- chronic obstructive pulmonary disease, handgrip strength, small airway disease, airway resistance, correlation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handgrip strengthDiagnostic test
Handgrip strength will be measured by 3 efforts.
| Study group | Role | What they receive |
|---|---|---|
| COPD | COPD patients aged 40 years or older with a post-bronchodilator ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) <0.7. Receives: Diagnostic Test: Handgrip strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between handgrip strength and small airway disease in COPD patients
This correlation will be reported as correlation coefficient (R).
Measured: At day 1 of the study
Secondary outcomes (1)
The best cutoff value of handgrip strength for predicting small airway disease in COPD patients
The best cutoff value will be determined by the area under the Receiver Operator Characteristic curve (ROC).
Measured: At day1 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start1 Mar 2023
- Primary completion31 Jan 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- Cross-sectional
- Enrolment
- 64 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narongkorn Saiphoklang, MD, Thammasat University
- Investigators
- Narongkorn Saiphoklang, MD, Principal investigator, Thammasat University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223139
- Sponsor's protocol ID
- MTU-EC-IM-0-215/65
- Status last verified
- Jan 2025
- First submitted
- 12 Jan 2024
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) and documents will be available for sharing immediately after publication for a period of 2 years.
Publications
Keawon T, Saiphoklang N. Association between handgrip strength and small airway disease in patients with stable chronic obstructive pulmonary disease. Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241281675. doi: 10.1177/17534666241281675.
PubMed 39367749
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Handgrip Strength and Small Airway Disease in Patients with Stable Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06223139
- Acronym / sponsor ID
- MTU-EC-IM-0-215/65
- Conditions
- COPD
- Keywords
- chronic obstructive pulmonary disease, handgrip strength, small airway disease, airway resistance, correlation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 25 Jan 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.
The goal of this observational study is to investigate the correlation between handgrip strength and small airway disease among patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:
- Is handgrip strength correlated with small airway disease in COPD patients? Participants will perform handgrip strength test and impulse oscillometry (IOS).
Detailed description
This is a cross-sectional study in COPD patients. COPD patients aged 40 years or older were included. Handgrip strength test and impulse oscillometry will be tested in each patient. Handgrip strength will be measured using a hand dynamometer. Small airway disease will be assessed using IOS.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD | – | Diagnostic Test: Handgrip strengthCOPD patients aged 40 years or older with a post-bronchodilator ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) <0.7. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients aged 40 years or older who are confirmed diagnosis by spirometry (post-bronchodilator FEV1/FVC <0.7) and smoking history 10 pack-years or more.
Key inclusion criteria (3 listed)
- COPD patients aged 40 years or older
- Confirmed diagnosis by spirometry (post-bronchodilator FEV1/FVC <0.7)
- Smoking history 10 pack-years or more
Key exclusion criteria (2 listed)
- COPD exacerbation within 3 months
- Inability to perform handgrip strength test or impulse oscillometry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Handgrip strengthHandgrip strength will be measured by 3 efforts. | Diagnostic test | COPD |
Primary outcome
Correlation between handgrip strength and small airway disease in COPD patients
Time frame: At day 1 of the study
This correlation will be reported as correlation coefficient (R).
1 secondary outcome
The best cutoff value of handgrip strength for predicting small airway disease in COPD patients
Time frame: At day1 of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Derived from this study: PubMed 39367749Keawon T, Saiphoklang N. Association between handgrip strength and small airway disease in patients with stable chronic obstructive pulmonary disease. Ther Adv Respir Dis. 2024 Jan-Dec;18:17534666241281675. doi: 10.1177/17534666241281675.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) and documents will be available for sharing immediately after publication for a period of 2 years.
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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. This study is not recruiting at the moment.
Narongkorn Saiphoklang, MD principal investigator
Thammasat University Faculty of Medicine
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 COPD, run by Thammasat University at 1 site in Thailand.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 17 Jan 2025. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between handgrip strength and small airway disease in COPD patients (time frame: At day 1 of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06223139, which also lists 1 linked publication.
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 17 Jan 2025.