Association Between Handgrip Strength and Small Airway Disease in Patients With Stable Chronic Obstructive Pulmonary Disease

March 28, 2024 updated by: Narongkorn Saiphoklang, MD, Thammasat University

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Pathumthani, Thailand, 12120
        • Recruiting
        • Thammasat University Faculty of Medicine
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • COPD patients aged 40 years or older
  • Confirmed diagnosis by spirometry (post-bronchodilator FEV1/FVC <0.7)
  • Smoking history 10 pack-years or more

Exclusion Criteria:

  • COPD exacerbation within 3 months
  • Inability to perform handgrip strength test or impulse oscillometry

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: Handgrip strength
Handgrip strength will be measured by 3 efforts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At day 1 of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The best cutoff value of handgrip strength for predicting small airway disease in COPD patients
Time Frame: At day1 of the study
The best cutoff value will be determined by the area under the Receiver Operator Characteristic curve (ROC).
At day1 of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thammasat University

Investigators

  • Principal Investigator: Narongkorn Saiphoklang, MD, Thammasat University Faculty of Medicine

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 22, 2024

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

May 30, 2024

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 28, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTU-EC-IM-0-215/65

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) and documents will be available for sharing immediately after publication for a period of 2 years.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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