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).
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
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.
- Conditions
- Interstitial Lung Diseases (ILD)
- 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.
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
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
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 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
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
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
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
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
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
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
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
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
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
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.
- First posted14 Aug 2025
- Study start25 Apr 2025
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung Diseases (ILD)Studies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anıl Gökçen, Marmara University
- Investigators
- Anıl Gökçen, Phsiotheraphist, Principal investigator
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the 6-Minute Pegboard and Ring Test in Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT07122141
- Acronym / sponsor ID
- Upperextremity_ILD
- Conditions
- Interstitial Lung Diseases (ILD)
- Keywords
- 6-minute pegboard and ring test, upper extremity, validity, reliability, Interstitial lung diseases (ILD)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 25 Apr 2025 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chest Diseases Clinic of Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- Neurological comorbidity,
- Orthopedic comorbidity that impairs upper extremity function,
- Kyphoscoliosis and/or severe postural abnormalities,
- Uncontrolled cardiac problems,
- Uncontrolled diagnosis of Diabetes Mellitus,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
6 Minutes Pegboard and Ring Test (6PBRT)
Time frame: Day 1
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.
6 Minutes Walking Tests (6MWT)
Time frame: Day 1
Total distance walked (in meters) during the 6MWT will be recorded. Higher distance reflects improved functional capacity.
Unsupported Upper-Limb Exercise Test (UULEX)
Time frame: Day 1
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.
11 secondary outcomes
1 Minute Sit to Stand Test (1MSTST)
Time frame: Day 1
Spirometric measurements (Forced vital capacity - FVC)
Time frame: Day 1
Spirometric measurements (First second forced expiratory volume - FEV1)
Time frame: Day 1
Spirometric measurements (FEV1/FVC ratio)
Time frame: Day 1
Carbon monoxide diffusion capacity
Time frame: Day 1
Gender-Age-Physiology (GAP) Index
Time frame: Day 1
Modified Medical Research Council Dyspnea Score
Time frame: Day 1
Handgrip Strength
Time frame: Day 1
Fatigue severity scale
Time frame: Day 1
London Chest Daily Activities of Living Scale
Time frame: Day 1
Saint George Quality of life questionnaire
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anıl Gökçen, Phsiotheraphist principal investigator
1 site in 1 country: see every site and its status.
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.