NCT06223139

Brief 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). 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

January 17, 2025

Status Verified

January 1, 2025

Enrollment Period

11 months

First QC Date

January 12, 2024

Last Update Submit

January 16, 2025

Conditions

Keywords

chronic obstructive pulmonary diseasehandgrip strengthsmall airway diseaseairway resistancecorrelation

Outcome Measures

Primary Outcomes (1)

  • Correlation between handgrip strength and small airway disease in COPD patients

    This correlation will be reported as correlation coefficient (R).

    At day 1 of the study

Secondary Outcomes (1)

  • The best cutoff value of handgrip strength for predicting small airway disease in COPD patients

    At day1 of the study

Study Arms (1)

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

Interventions

Handgrip strengthDIAGNOSTIC_TEST

Handgrip strength will be measured by 3 efforts.

COPD

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thammasat University Faculty of Medicine

Pathum Thani, Changwat Pathum Thani, 12120, Thailand

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Narongkorn Saiphoklang, MD

    Thammasat University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 12, 2024

First Posted

January 25, 2024

Study Start

March 1, 2023

Primary Completion

January 31, 2024

Study Completion

May 31, 2024

Last Updated

January 17, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP

Locations