NCT07010211

Brief Summary

This study aims to develop a non-invasive and contact-free diagnostic system that uses artificial intelligence (AI) to detect Chronic Obstructive Pulmonary Disease (COPD) by analyzing walking patterns. Participants in this study will include individuals with a diagnosis of COPD and healthy volunteers. All participants will undergo a 6-minute walk test (6MWT), during which their movements will be recorded using video. In addition, they will complete a breathing test (spirometry) and a short questionnaire about symptoms. The recorded videos will be analyzed using an AI model based on motion tracking software. This model will evaluate walking-related parameters such as step count, step length, walking time, and total walking distance. The goal is to determine whether walking patterns can be used to detect COPD with high accuracy, especially in situations where traditional lung function tests may not be available or feasible. This study is observational and does not involve any experimental drug or treatment. The results may help to create new diagnostic tools that are easy to use, safe, and accessible for early detection of COPD.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

May 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

June 8, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

May 30, 2025

Last Update Submit

May 30, 2025

Conditions

Keywords

Chronic Obstructive Pulmonary DiseaseArtificial IntelligenceMotion Analysis6-Minute Walk TestSpirometry

Outcome Measures

Primary Outcomes (1)

  • Diagnostic Accuracy of AI-Based Gait Analysis for Detection of COPD

    Evaluation of the sensitivity, specificity, and overall accuracy of the artificial intelligence-based motion analysis system in identifying patients with COPD compared to spirometry (gold standard).

    At time of initial assessment (Day 0)

Study Arms (2)

COPD Group

Participants with a confirmed diagnosis of Chronic Obstructive Pulmonary Disease (COPD) based on spirometry.

Other: Gait Video Recording and Analysis

Control Group

Healthy volunteers with no history of pulmonary disease and normal spirometry results.

Other: Gait Video Recording and Analysis

Interventions

Participants undergo a 6-minute walk test (6MWT) while being recorded on video. The footage is later analyzed using artificial intelligence algorithms to assess gait parameters.

COPD GroupControl Group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will include individuals between the ages of 40 and 80. The study population consists of two cohorts: patients previously diagnosed with Chronic Obstructive Pulmonary Disease (COPD) based on spirometry results, and healthy volunteers with no history of pulmonary disease. All participants must be physically able to complete a 6-minute walk test and willing to participate in video-based gait assessment.

You may qualify if:

  • Aged between 40 and 80 years
  • Ability to provide informed consent
  • For COPD group: Previously diagnosed with COPD based on GOLD criteria (FEV1/FVC \< 0.70)
  • For control group: No history of pulmonary disease and normal spirometry results
  • Physically able to perform the 6-minute walk test
  • Willingness to participate in video recording during gait analysis

You may not qualify if:

  • Younger than 40 or older than 80 years
  • Acute respiratory tract infection or other active infections
  • Severe heart failure, advanced arrhythmias, or other serious cardiovascular conditions
  • Physical disability preventing completion of the 6-minute walk test
  • Neurological or orthopedic conditions causing major gait disturbance
  • Inability to perform spirometry due to physical or cognitive limitations
  • Pregnant or breastfeeding women Diagnosed with other serious pulmonary diseases (e.g., interstitial lung disease, active tuberculosis) Refusal to give informed consent or to be video recorded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Altan G, Kutlu Y, Allahverdi N. Deep Learning on Computerized Analysis of Chronic Obstructive Pulmonary Disease. IEEE J Biomed Health Inform. 2019 Jul 26. doi: 10.1109/JBHI.2019.2931395. Online ahead of print.

    PMID: 31369388BACKGROUND
  • Agusti A, Celli BR, Criner GJ, Halpin D, Anzueto A, Barnes P, Bourbeau J, Han MK, Martinez FJ, Montes de Oca M, Mortimer K, Papi A, Pavord I, Roche N, Salvi S, Sin DD, Singh D, Stockley R, Lopez Varela MV, Wedzicha JA, Vogelmeier CF. Global Initiative for Chronic Obstructive Lung Disease 2023 Report: GOLD Executive Summary. Eur Respir J. 2023 Apr 1;61(4):2300239. doi: 10.1183/13993003.00239-2023. Print 2023 Apr.

    PMID: 36858443BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Thoracic Surgery

Study Record Dates

First Submitted

May 30, 2025

First Posted

June 8, 2025

Study Start

August 1, 2025

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

June 8, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) that underlie the results reported in this study will be shared with qualified researchers upon reasonable request. Data will be de-identified to protect participant confidentiality and shared for academic research purposes only, in accordance with institutional ethics approval and data protection policies.