NCT06948916

Brief Summary

Interstitial lung diseases (ILD) are a heterogeneous group of chronic respiratory diseases that cause significant mortality and morbidity worldwide, characterized by diffuse inflammation in the lung parenchyma and vascular structures, can progress to fibrosis, have known or unknown etiology, and can develop secondary to systemic autoimmune connective tissue diseases other than diseases where the primary pathology is in the lung. The 6-minute peg-board and ring test, which was first developed to determine the upper extremity exercise capacity of chronic obstructive pulmonary disease patients, is an exercise test used to evaluate upper extremity functional exercise capacity in different lung diseases. It has been determined that there is no study on the validity and reliability of this test in individuals with ILD.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
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

Study Start

First participant enrolled

December 12, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 29, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2025

Completed
Last Updated

April 29, 2025

Status Verified

April 1, 2025

Enrollment Period

7 months

First QC Date

April 22, 2025

Last Update Submit

April 22, 2025

Conditions

Keywords

Interstitial lung diseasesExercise CapacityUpper extremity

Outcome Measures

Primary Outcomes (1)

  • Upper extremity functional exercise capacity

    To evaluate upper extremity functional exercise capacity, 6-minute pegboard and ring tests will be applied twice with 15-30 minute intervals. Before the test, individuals will be seated and rested for at least 10 minutes. Individuals will be provided with detailed information about the application of the test before the test. Patients will be informed not to interfere with rings that fall during the test and to continue the test. It will be explained that they can stop and rest if they feel too uncomfortable to continue the test, but this time will be included in the test duration. Before the actual test, subjects will be allowed to move up and down one loop as a practice to learn the test procedure. As a test result, the total number of rings worn at the end of six minutes will be recorded in numbers.

    Trough study completion, an average of 1 year

Secondary Outcomes (12)

  • Upper Extremity Maximal Exercise Capacity

    Trough study completion, an average of 1 year

  • Upper extremity activities of daily living

    Trough study completion, an average of 1 year

  • Dyspnea

    Trough study completion, an average of 1 year

  • Respiratory Muscle Strength

    Trough study completion, an average of 1 year

  • Peripheral muscle strength

    Trough study completion, an average of 1 year

  • +7 more secondary outcomes

Study Arms (1)

Patients with ILD

Patients diagnosed with ILD according to ATS/ERS criteria

Eligibility Criteria

Age18 Years - 75 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale and Male
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients diagnosed with ILD

You may qualify if:

  • Patients diagnosed with ILD according to ATS/ERS criteria,
  • Ages between 18 and 75,
  • Pulmonary infection during the previous month,
  • Participants who voluntarily participated in the study were included.

You may not qualify if:

  • Patients were excluded if they had:
  • Acute pulmonary exacerbation or respiratory infection in the last four weeks
  • Obstructive lung disease
  • Systemic conditions affecting neurological, neuromuscular, orthopedic, or physical functions
  • Recent participation in a planned exercise program (within three months)
  • Cognitive impairment affecting exercise test understanding
  • Contraindications to exercise testing per the American Sports Medicine Association
  • Cancer, renal, or hepatic disease
  • Aortic stenosis, complex arrhythmia, or aortic aneurysm
  • Serious cardiovascular diseases like uncontrolled hypertension, diabetes, heart failure, or arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit

Ankara, 06490, Turkey (Türkiye)

RECRUITING

Related Links

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Meral BOŞNAK GÜÇLÜ, Prof. Dr.

    Gazi University

    STUDY DIRECTOR
  • Nazire Nur YILDIZ, M.Sc.

    Nigde Omer Halisdemir University

    STUDY CHAIR
  • Nilgün YILMAZ DEMİRCİ, Prof. Dr.

    Gazi University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

CONTACT

Nazire Nur YILDIZ, M.Sc.

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

April 22, 2025

First Posted

April 29, 2025

Study Start

December 12, 2024

Primary Completion

July 12, 2025

Study Completion

August 12, 2025

Last Updated

April 29, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

To protect patient data, it will not be shared.

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