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Recruiting NCT06948916

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

Observational Interstitial Lung Diseases (ILD) Exercise Capacity Upper Extremity

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In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Interstitial Lung Diseases (ILD), Exercise Capacity, Upper Extremity. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Upper extremity functional exercise capacity [Time frame: Trough study completion, an average of 1 year]
Secondary outcome measures (12)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Turkey (Türkiye) · 1 center
  • Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, — Ankara

Identifiers

NCT: NCT06948916 · 2024 - 1688

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗