Validity and Reliability of 6-minute Pegboard and Ring Test in Patients With Interstitial Lung Disease

April 22, 2025 updated by: Meral Boşnak Güçlü, Gazi University

Investigation of the Validity and Reliability of 6-minute Pegboard and Ring Test in Patients With Interstitial Lung Disease

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.

Study Overview

Detailed Description

Interstitial lung diseases (ILD) are chronic respiratory diseases that cause significant mortality and morbidity worldwide. 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. In this patient group, the upper extremity muscles are seriously affected. In addition, serious desaturation develops during exercise tests that require walking and the use of larger muscle groups, such as the 6-minute walking test. For this reason, upper extremity aerobic exercise capacity gains importance in this patient group. There are no studies in the literature on the validity and reliability of 6-PBRT in patients with ILD, although its validity and reliability have been studied in different patient groups such as COPD, PAH, and asthma. The primary aim of our study was to determine the validity and reliability of the 6-minute peg-board and ring test for patients with interstitial lung disease.

The study will be conducted between June 2023 and February 2025 on patients diagnosed with interstitial lung disease who were referred to the Cardiopulmonary Rehabilitation Unit of the Department of Physiotherapy and Rehabilitation, Faculty of Medicine, Gazi University for rehabilitation by the Department of Chest Diseases, Faculty of Medicine, Gazi University. Data from patients who have been followed up will be analyzed retrospectively.

Study Type

Observational

Enrollment (Estimated)

34

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

      • Ankara, Turkey, 06490
        • Recruiting
        • Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
        • Contact:
        • Principal Investigator:
          • Nazire Nur YILDIZ, M.Sc.
        • Principal Investigator:
          • Nilgün YILMAZ DEMİRCİ, Prof. Dr.

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

Probability Sample

Study Population

Patients diagnosed with ILD

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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
Patients with ILD
Patients diagnosed with ILD according to ATS/ERS criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Upper extremity functional exercise capacity
Time Frame: Trough study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary function (Forced vital capacity (FVC))
Time Frame: Trough study completion, an average of 2 year
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced vital capacity (FVC) will be evaluated.
Trough study completion, an average of 2 year
Dyspnea
Time Frame: Trough study completion, an average of 1 year
The assessment of dyspnea at rest, during, and after exercise training will be made with the Modified Borg scale. The Modified Borg scale is a subjective scale and scores the shortness of breath at rest and/or during activity between 0-10. The lowest score of 0 (zero) indicates 'none', and the highest score of 10 (ten) indicates 'maximal' shortness of breath. The Modified Medical Research Council (MMRC) dyspnea scale will be used to determine the perception of dyspnea during activities of daily living. The London Chest Activities of Daily Living Scale, developed by Garrod et al. to examine dyspnea that occurs with daily living activities in chronic obstructive pulmonary disease and whose Turkish validity and reliability were performed by Saka et al., will be used to assess shortness of breath that occurs during activities of daily living.
Trough study completion, an average of 1 year
Respiratory Muscle Strength
Time Frame: Trough study completion, an average of 1 year
Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device.
Trough study completion, an average of 1 year
Pulmonary function (Forced expiratory volume in the first second (FEV1))
Time Frame: Trough study completion, an average of 1 year
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced expiratory volume in the first second (FEV1) will be evaluated.
Trough study completion, an average of 1 year
Pulmonary function (FEV1/FVC)
Time Frame: Trough study completion, an average of 1 year
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, FEV1 / FVC will be evaluated.
Trough study completion, an average of 1 year
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
Time Frame: Trough study completion, an average of 1 year
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated.
Trough study completion, an average of 1 year
Pulmonary function (Peak flow rate (PEF))
Time Frame: Trough study completion, an average of 1 year
Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, peak flow rate (PEF) will be evaluated.
Trough study completion, an average of 1 year
Disease Related Quality of life
Time Frame: Trough study completion, an average of 1 year
The Saint George Respiratory Questionnaire is a questionnaire used to assess the quality of life in respiratory diseases and its Turkish validity and reliability were conducted by Polatlı et al. The questionnaire consists of 3 sections: symptoms (8 items), activities (16 items), and effects of the disease (26 items) and a total of 50 items: The 3 sections of the test are scored separately. Then, a total score is obtained. The total score varies between 0-100. A score of zero is normal, while a score of 100 indicates maximum disability. As the total score increases, it indicates that the patients' quality of life is poor.
Trough study completion, an average of 1 year
Upper Extremity Maximal Exercise Capacity
Time Frame: Trough study completion, an average of 1 year
Upper extremity maximal exercise capacity will be assessed by symptom-limited cardiopulmonary exercise testing on arm ergometer at gradually increasing workload, and oxygen consumption will be measured during the test.
Trough study completion, an average of 1 year
Upper extremity activities of daily living
Time Frame: Trough study completion, an average of 1 year
Limitations in upper extremity activities of daily living will be assessed with the Milliken Activities of Daily Living Scale (ACS), a patient-reported outcome measure. The Turkish validity-reliability study was conducted by Semin Akel and colleagues in 2012. The scale contains 47 items related to different activities of daily living, including meal preparation, eating, personal care, self-dressing, handling objects, house cleaning, laundry, and other activities. There is an integrated scoring procedure that uses the multiplication of each ability score by each requirement score, yielding a possible score of 15 for each item and a possible total integrated score of 705. The total score was used in this study. Lower scores indicate greater limitations in the ability to perform daily tasks with the upper extremities.
Trough study completion, an average of 1 year
Peripheral muscle strength
Time Frame: Trough study completion, an average of 1 year
Shoulder flexor and shoulder abductor muscle strength will be assessed with a portable handheld dynamometer (JTECH Power Track Commander, Baltimore, USA).
Trough study completion, an average of 1 year
Pulmonary function (Diffusion capacity for carbon monoxide (DLCO))
Time Frame: Trough study completion, an average of 1 year
Carbon monoxide diffusing capacity of the lung (DLCO) is a measurement to assess the lungs' ability to transfer gas from inspired air to the bloodstream. Its measurement uses carbon monoxide to calculate the pulmonary diffusion capacity. The most common method is the standard single-breathe diffusing capacity test. It is expressed in mmol/(min*kPa) and as a percentage (%) of the expected value.
Trough study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Director: Meral BOŞNAK GÜÇLÜ, Prof. Dr., Gazi University
  • Principal Investigator: Nilgün YILMAZ DEMİRCİ, Prof. Dr., Gazi University
  • Study Chair: Nazire Nur YILDIZ, M.Sc., Nigde Omer Halisdemir University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

December 12, 2024

Primary Completion (Estimated)

July 12, 2025

Study Completion (Estimated)

August 12, 2025

Study Registration Dates

First Submitted

April 22, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

April 29, 2025

Last Update Submitted That Met QC Criteria

April 22, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect patient data, it will not be shared.

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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