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Interstitial Lung Diseases (ILD)NCT07122141

Validity and Reliability of the 6-Minute Pegboard and Ring Test in Interstitial Lung Disease

An observational study of Interstitial Lung Diseases (ILD), run by Marmara University at 1 site in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The aim of this study is to investigate the validity and reliability of the 6 Minutes Pegboard and Ring Test (6PBRT) in patients with Interstitial Lung Disease (ILD). Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Interstitial Lung Diseases (ILD)
How many people
27 participants
Where
1 siteTurkey (Türkiye)
Study dates
25 Apr 2025to Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Chest Diseases Clinic of Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital

Who may be able to join

  • who were diagnosed with ILD according to the ATS/ERS/JRS/ALAT guidelines,
  • were over 18 years of age,
  • had not changed their treatment for the last 3 months,
  • had a stable clinical status for the last 3 months.

Who cannot join

  • Neurological comorbidity,
  • Orthopedic comorbidity that impairs upper extremity function,
  • Kyphoscoliosis and/or severe postural abnormalities,
  • Uncontrolled cardiac problems,
  • Uncontrolled diagnosis of Diabetes Mellitus,
  • Ischemic heart disease,
Show all 13Show fewer
  • Newly diagnosed history of cancer,
  • Diagnosis of obstructive pulmonary disease,
  • Cognitive impairments such as Alzheimer's or dementia,
  • Use of immunosuppressive medications (excluding corticosteroids),
  • History of recent surgery,
  • Refusal to answer questions,
  • Refusal to participate voluntarily.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital

    Istanbul

Other trials in Turkey (Türkiye)

About this study

The aim of this study is to investigate the validity and reliability of the 6 Minutes Pegboard and Ring Test (6PBRT) in patients with Interstitial Lung Disease (ILD).

Read the detailed description

Our study was conducted in the Chest Diseases Clinic of Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital. Our study was approved by the Marmara University Faculty of Health Sciences Non-Interventional Clinical Research Ethics Committee and was conducted in accordance with the Declaration of Helsinki. Signed informed consent was obtained from the participants.

Keywords
6-minute pegboard and ring test, upper extremity, validity, reliability, Interstitial lung diseases (ILD)
Medical subject headings
Lung Diseases, Interstitial

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6 Minutes Pegboard and Ring Test (6PBRT)

    The 6-Minute Pegboard and Ring Test (6PBRT) is designed to assess upper extremity functional capacity using unsupported arm movements. The setup includes four horizontally aligned bars: two at shoulder height and two positioned 20 cm above. Participants, seated with back support, sequentially transfer rings between the bars for six minutes, and the total number of rings moved serves as the performance score.

    Measured: Day 1

  2. 6 Minutes Walking Tests (6MWT)

    Total distance walked (in meters) during the 6MWT will be recorded. Higher distance reflects improved functional capacity.

    Measured: Day 1

  3. Unsupported Upper-Limb Exercise Test (UULEX)

    Patients will be instructed to lift five bars consecutively and rhythmically until the onset of fatigue. The bars will have incremental weights of 200 g, 500 g, 1 kg, and 2 kg, respectively. The duration of the activity will be recorded to assess the patients' endurance levels.

    Measured: Day 1

Secondary outcomes (11)
  1. 1 Minute Sit to Stand Test (1MSTST)

    The 1-Minute Sit-to-Stand Test (1MSTST) is a simple, inexpensive, and practical assessment used to evaluate functional capacity in a small space. During the test, participants are asked to repeatedly sit down and stand up from a fixed chair as quickly as possible for one minute, without using their arms for support.

    Measured: Day 1

  2. Spirometric measurements (Forced vital capacity - FVC)

    It is used to assess respiratory function and is measured using a spirometer. Forced Vital Capacity (FVC) refers to the maximum volume of air that can be forcefully exhaled from the lungs after a full inhalation. This value can be expressed in liters or as a percentage.

    Measured: Day 1

  3. Spirometric measurements (First second forced expiratory volume - FEV1)

    It is employed to assess respiratory functions and is measured using a spirometer. Forced Expiratory Volume in the first second (FEV₁) represents the volume of air that can be forcefully exhaled within the first second of a maximal exhalation. This parameter can be expressed either in liters or as a percentage.

    Measured: Day 1

  4. Spirometric measurements (FEV1/FVC ratio)

    It is employed to assess respiratory function and is measured with a spirometer. The value is obtained by dividing FEV₁ by FVC, and the result is expressed as a percentage.

    Measured: Day 1

  5. Carbon monoxide diffusion capacity

    Carbon monoxide diffusion capacity (DLCO) is the measurement of the passage of carbon monoxide gas in inspired air into the lung capillary blood. Diffusion test is performed in the pulmonary function test laboratory.

    Measured: Day 1

  6. Gender-Age-Physiology (GAP) Index

    The Gender-Age-Physiology (GAP) index is a multidimensional assessment index developed and validated to predict mortality in ILD. The ILD-GAP index is divided into stages 0-1, 2-3, 4-5, and >5, which predict the risk of death in the 1st, 2nd, and 3rd years. The GAP index will be calculated based on gender (0-1 points), age (0-2 points), %FVC (0-2 points), and %DLCO (0-3 points). It is classified into Stage I (0-3 points), Stage II (4-5 points), and Stage III (6-8 points), with prognosis worsening as it progresses from Stage I to Stage III.

    Measured: Day 1

  7. Modified Medical Research Council Dyspnea Score

    The Modified Medical Research Council (mMRC) Dyspnea Scale assesses the sensation of breathlessness as perceived by the individual. The severity of dyspnea is scored on a scale ranging from 0 to 4, where 0 indicates no perception of dyspnea and 4 represents severe breathlessness.

    Measured: Day 1

  8. Handgrip Strength

    A manual hydraulic dynamometer will be used for the hand grip strength test, taking into account the recommendations of the American Association of Occupational Therapists (AAOT). During the test, measurements will be taken while the patient is seated with back support, shoulder in adduction and neutral position, elbow at 90° flexion, and forearm in neutral position.

    Measured: Day 1

  9. Fatigue severity scale

    he fatigue levels of individuals will be evaluated using the Fatigue Severity Scale. This scale comprises nine items rated on a 7-point Likert scale, reflecting the individual's perception of fatigue, which may indicate the need for medical intervention. The total score is 63. Higher scores indicate more severe fatigue.

    Measured: Day 1

  10. London Chest Daily Activities of Living Scale

    The feeling of breathlessness experienced during daily living activities was assessed using the London Chest Daily Activities of Living Scale (LCADL). The scale consists of a total of 15 items divided into four sections: personal care (4 items), housework (6 items), physical activity (2 items), and leisure activities (3 items). Each item is scored on a scale of 0-5. The total score for the scale is 75. A high score indicates an increased perception of shortness of breath during daily living activities.

    Measured: Day 1

  11. Saint George Quality of life questionnaire

    The St. George's Respiratory Questionnaire is designed to assess health-related quality of life in individuals with respiratory conditions. It provides four separate scores: Symptoms, Activity, Impacts, and an overall Total score. The scale ranges from 0 to 100, where 0 represents no impairment in quality of life and 100 indicates the most severe impairment.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2025
  2. Study start25 Apr 2025
  3. Primary completionSep 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07122141
Sponsor's protocol ID
Upperextremity_ILD
Status last verified
Aug 2025
First submitted
7 Aug 2025
Last updated
14 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Interstitial Lung Diseases (ILD), run by Marmara University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6 Minutes Pegboard and Ring Test (6PBRT) (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.

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