Interstitial Lung Diseases (ILD)NCT06948916
Validity and Reliability of 6-minute Pegboard and Ring Test in Patients With Interstitial Lung Disease
An observational study of Interstitial Lung Diseases (ILD) and Exercise Capacity, run by Gazi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Interstitial Lung Diseases (ILD), Exercise Capacity, Upper Extremity
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Dec 2024to 12 Aug 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with ILD
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nazire Nur YILDIZ, M.Sc. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
Ankara, 06490
Meral BOŞNAK GÜÇLÜ, Prof. Dr., +903122162647, meralbosnak@gazi.edu.tr
Nazire Nur YILDIZ, M.Sc.
About this study
Official title: 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.
Read the 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.
- Keywords
- Interstitial lung diseases, Exercise Capacity, Upper extremity
- Medical subject headings
- Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with ILD | Patients diagnosed with ILD according to ATS/ERS criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Trough study completion, an average of 1 year
Secondary outcomes (12)
Upper Extremity Maximal Exercise Capacity
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.
Measured: Trough study completion, an average of 1 year
Upper extremity activities of daily living
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.
Measured: Trough study completion, an average of 1 year
Dyspnea
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.
Measured: Trough study completion, an average of 1 year
Respiratory Muscle Strength
Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device.
Measured: Trough study completion, an average of 1 year
Peripheral muscle strength
Shoulder flexor and shoulder abductor muscle strength will be assessed with a portable handheld dynamometer (JTECH Power Track Commander, Baltimore, USA).
Measured: Trough study completion, an average of 1 year
Disease Related Quality of life
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.
Measured: Trough study completion, an average of 1 year
Pulmonary function (Forced expiratory volume in the first second (FEV1))
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.
Measured: Trough study completion, an average of 1 year
Pulmonary function (Forced vital capacity (FVC))
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.
Measured: Trough study completion, an average of 2 year
Pulmonary function (FEV1/FVC)
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.
Measured: Trough study completion, an average of 1 year
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
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.
Measured: Trough study completion, an average of 1 year
Pulmonary function (Peak flow rate (PEF))
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.
Measured: Trough study completion, an average of 1 year
Pulmonary function (Diffusion capacity for carbon monoxide (DLCO))
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.
Measured: Trough study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start12 Dec 2024
- Primary completion12 Jul 2025 (estimated)
- Study completion12 Aug 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 Gazi 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
- Retrospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Meral BOŞNAK GÜÇLÜ, Prof. Dr., Study director, Gazi UniversityNazire Nur YILDIZ, M.Sc., Study chair, Nigde Omer Halisdemir UniversityNilgün YILMAZ DEMİRCİ, Prof. Dr., Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948916
- Sponsor's protocol ID
- 2024 - 1688
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect patient data, it will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Validity and Reliability of 6-minute Pegboard and Ring Test in Patients With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT06948916
- Acronym / sponsor ID
- 2024 - 1688
- Keywords
- Interstitial lung diseases, Exercise Capacity, Upper extremity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 12 Dec 2024 (actual)
- Primary completion
- 12 Jul 2025 (estimated)
- Study completion
- 12 Aug 2025 (estimated)
- First posted
- 29 Apr 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.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with ILD | – | –Patients diagnosed with ILD according to ATS/ERS criteria |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with ILD
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
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
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.
12 secondary outcomes
Upper Extremity Maximal Exercise Capacity
Time frame: Trough study completion, an average of 1 year
Upper extremity activities of daily living
Time frame: Trough study completion, an average of 1 year
Dyspnea
Time frame: Trough study completion, an average of 1 year
Respiratory Muscle Strength
Time frame: Trough study completion, an average of 1 year
Peripheral muscle strength
Time frame: Trough study completion, an average of 1 year
Disease Related Quality of life
Time frame: 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 (Forced vital capacity (FVC))
Time frame: Trough study completion, an average of 2 year
Pulmonary function (FEV1/FVC)
Time frame: 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 (Peak flow rate (PEF))
Time frame: 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
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 29 Apr 2025.
- Celli BR, Rassulo J, Make BJ. Dyssynchronous breathing during arm but not leg exercise in patients with chronic airflow obstruction. New England Journal of Medicine. 1986;314(23):1485-90.Link provided by the sponsor.
- Zhan S, Cerny FJ, Gibbons WJ, Mador MJ, Wu Y-W. Development of an unsupported arm exercise test in patients with chronic obstructive pulmonary disease. Journal of Cardiopulmonary Rehabilitation and Prevention. 2006;26(3):180-7.Link provided by the sponsor.
- Kahraman BÖ, Özsoy İ, Tanrıverdi A, Akdeniz B, Özpelit E, Şentürk B, et al. Validity and reliability of the 6-minute pegboard ring test in patients with pulmonary hypertension. Türk Fizyoterapi ve Rehabilitasyon Dergisi. 2020;31(2):210-7.Link provided by the sponsor.
- Calik-Kutukcu E, Tekerlek H, Bozdemir-Ozel C, Karaduz BN, Cakmak A, Inal-Ince D, et al. Validity and reliability of 6-minute pegboard and ring test in patients with asthma. Journal of Asthma. 2022;59(7):1387-95.Link provided by the sponsor.
- Takeda K, Kawasaki Y, Yoshida K, Nishida Y, Harada T, Yamaguchi K, et al. The 6-minute pegboard and ring test is correlated with upper extremity activity of daily living in chronic obstructive pulmonary disease. International Journal of Chronic ObstructiLink provided by the sponsor.
- Individual participant dataSharing planned: No. To protect patient data, it will not be shared.
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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.
Nazire Nur YILDIZ, M.Sc. contact
Meral BOŞNAK GÜÇLÜ, Prof. Dr. study director
Gazi University
Nazire Nur YILDIZ, M.Sc. study chair
Nigde Omer Halisdemir University
Nilgün YILMAZ DEMİRCİ, Prof. Dr. principal investigator
Gazi University
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) and Exercise Capacity, run by Gazi 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 10 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: looking for participants now, as of the sponsor's last update on 29 Apr 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?
Contact Meral BOŞNAK GÜÇLÜ, Prof. Dr. (+903122162647, meralbosnak@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper extremity functional exercise capacity (time frame: Trough study completion, an average of 1 year). 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 29 Apr 2025.