Clinical trial NCT06948916: Validity and Reliability of 6-minute Pegboard and Ring Test in Patients With Interstitial Lung Disease
Official title: Investigation of the Validity and Reliability of 6-minute Pegboard and Ring Test in Patients With Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interstitial Lung Diseases (ILD)
Exercise Capacity
Upper Extremity
Keywords: Interstitial lung diseases
Exercise Capacity
Upper extremity
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with ILD

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Upper extremity functional exercise capacity
timeFrame: Trough study completion, an average of 1 year
Secondary outcomes:
measure: Upper Extremity Maximal Exercise Capacity
timeFrame: Trough study completion, an average of 1 year
measure: Upper extremity activities of daily living
timeFrame: Trough study completion, an average of 1 year
measure: Dyspnea
timeFrame: Trough study completion, an average of 1 year
measure: Respiratory Muscle Strength
timeFrame: Trough study completion, an average of 1 year
measure: Peripheral muscle strength
timeFrame: Trough study completion, an average of 1 year
measure: Disease Related Quality of life
timeFrame: Trough study completion, an average of 1 year
measure: Pulmonary function (Forced expiratory volume in the first second (FEV1))
timeFrame: Trough study completion, an average of 1 year
measure: Pulmonary function (Forced vital capacity (FVC))
timeFrame: Trough study completion, an average of 2 year
measure: Pulmonary function (FEV1/FVC)
timeFrame: Trough study completion, an average of 1 year
measure: Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))
timeFrame: Trough study completion, an average of 1 year
measure: Pulmonary function (Peak flow rate (PEF))
timeFrame: Trough study completion, an average of 1 year
measure: Pulmonary function (Diffusion capacity for carbon monoxide (DLCO))
timeFrame: Trough study completion, an average of 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
Study officials:
affiliation: Gazi University
name: Meral BOŞNAK GÜÇLÜ, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Nigde Omer Halisdemir University
name: Nazire Nur YILDIZ, M.Sc.
role: STUDY_CHAIR
affiliation: Gazi University
name: Nilgün YILMAZ DEMİRCİ, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: