Chronic Obstructive Pulmonary DiseaseNCT06220851
Correlation Between Handgrip Strength and Air Trapping in Patients with Stable Chronic Obstructive Pulmonary Disease
An observational study of Chronic Obstructive Pulmonary Disease, run by Thammasat University at 1 site in Thailand.
Trial summary
The goal of this observational study is to investigate the relationship between handgrip strength and air trapping in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is: Is handgrip strength correlated with air trapping in COPD patients? Participants will perform… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Handgrip strength
- How many people
- 72 participants
- Where
- 1 siteThailand
- Study dates
- 1 May 2022to 31 May 2024
- 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 (postbronchodilator FEV1/FVC <0.7) and smoking history 10 pack-years or more.
Who may be able to join
- Age 40 years or older
- Postbronchodilator FEV1/FVC <0.7
- >10 pack-year smoking history
Who cannot join
- COPD exacerbation within 3 months
- Inability to perform handgrip strength test or lung volume measurement
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 relationship between handgrip strength and air trapping in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:
- Is handgrip strength correlated with air trapping in COPD patients? Participants will perform handgrip strength test and lung volume measurement.
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 lung volume measurement will be tested in each patient. Handgrip strength will be measured using a hand dynamometer. Lung volume will be assessed using a body plethysmograph.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Handgrip strength
- Keywords
- chronic obstructive pulmonary disease, handgrip strength, air trapping, lung volume, 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 postbronchodilator ratio of forced expiratory volume at 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 air trapping 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 air trapping in COPD patients
The best cutoff value will be determined by the area under the Receiver Operator Characteristic curve (ROC).
Measured: At day 1 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 posted24 Jan 2024
- Study start1 May 2022
- Primary completion31 Dec 2023
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Narongkorn Saiphoklang, MD, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06220851
- Sponsor's protocol ID
- MTU-EC-IM-0-209/65
- Status last verified
- Jan 2025
- First submitted
- 12 Jan 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data (IPD) and documents will be available for sharing immediately after publication for a period of 2 years.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Handgrip Strength and Air Trapping in Patients with Stable Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT06220851
- Acronym / sponsor ID
- MTU-EC-IM-0-209/65
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease, handgrip strength, air trapping, lung volume, correlation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 24 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 relationship between handgrip strength and air trapping in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is:
- Is handgrip strength correlated with air trapping in COPD patients? Participants will perform handgrip strength test and lung volume measurement.
Detailed description
This is a cross-sectional study in COPD patients. COPD patients aged 40 years or older were included. Handgrip strength test and lung volume measurement will be tested in each patient. Handgrip strength will be measured using a hand dynamometer. Lung volume will be assessed using a body plethysmograph.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD | – | Diagnostic Test: Handgrip strengthCOPD patients aged 40 years or older with a postbronchodilator ratio of forced expiratory volume at 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 (postbronchodilator FEV1/FVC <0.7) and smoking history 10 pack-years or more.
Key inclusion criteria (3 listed)
- Age 40 years or older
- Postbronchodilator FEV1/FVC <0.7
- >10 pack-year smoking history
Key exclusion criteria (2 listed)
- COPD exacerbation within 3 months
- Inability to perform handgrip strength test or lung volume measurement
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 air trapping 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 air trapping in COPD patients
Time frame: At day 1 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 20 Jan 2025.
- Individual participant dataSharing planned: Yes. Individual patient 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Obstructive Pulmonary Disease, 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 20 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 air trapping 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?
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 20 Jan 2025.