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Recruiting NCT06948942

Exercise Capacity, Muscle Oxygenation, and Physical Activity Between Patients With Interstitial Lung Disease

Observational Interstitial Lung Diseases (ILD) Healthy Individuals Exercise Capacity Muscle Oxygenation

For patients and families

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), Healthy Individuals, Exercise Capacity, Muscle Oxygenation. 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

Comparison of Exercise Capacity, Muscle Oxygenation and Physical Activity Levels Between Patients With Interstitial Lung Disease and Healthy Individuals

Overview

Interstitial lung diseases (ILD) are a group of chronic respiratory diseases that cause significant mortality and morbidity worldwide. Although there are studies in the literature comparing different lung disease groups with healthy individuals, it has been determined that there is no study comparing the exercise capacity, muscle oxygenation, physical activity level, respiratory functions, respiratory and peripheral muscle strength, inspiratory muscle endurance, quality of life and sleep quality of individuals diagnosed with ILD with healthy individuals.

Detailed description

Interstitial lung diseases (ILD) are a group of chronic respiratory diseases that cause significant mortality and morbidity worldwide. Patients with interstitial lung disease experience a decrease in both static and dynamic lung volumes and carbon monoxide diffusion capacity (DLCO). As a result of this pathological mechanism, exertional dyspnea and exercise intolerance increase. Therefore, individuals with ILD tend to avoid activities that will increase shortness of breath, which leads to physical inactivity and an increasingly sedentary lifestyle. Due to this vicious cycle, individuals whose functional exercise capacity is also limited become more dependent in daily life activities. In addition, peripheral muscle dysfunction is another important factor that causes exercise intolerance in individuals with all chronic lung diseases, including ILD. Although there are studies in the literature comparing different lung disease groups with healthy individuals, it has been determined that there is no study comparing the exercise capacity, muscle oxygenation, physical activity level, respiratory functions, respiratory and peripheral muscle strength, and inspiratory muscle endurance of individuals with ILD with healthy individuals. The primary aim of our study was to compare the exercise capacity, muscle oxygenation and physical activity levels of patients with interstitial lung disease and healthy individuals. The secondary aim of our study was to compare the respiratory functions, respiratory and peripheral muscle strength, inspiratory muscle endurance, dyspnea, quality of life and sleep quality of patients with interstitial lung disease and healthy individuals.

Primary outcome measures

  • Maximal exercise capacity [Time frame: Trough study completion, an average of 1 year]
  • Muscle Oxygenation [Time frame: Trough study completion, an average of 1 year]
  • Physical Activity Level [Time frame: Trough study completion, an average of 1 year]
Secondary outcome measures (12)
  • Upper extremity functional exercise capacity [Time frame: Trough study completion, an average of 1 year]
  • Lower extremity functional exercise capacity [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]
  • Inspiratory muscle endurance [Time frame: Trough study completion, an average of 1 year]
  • Peripheral muscle strength [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 1 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]
  • Disease Related Quality of life [Time frame: Trough study completion, an average of 1 year]

Eligibility criteria

Patients who will participate in the study;

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

For healthy individuals who will participate in the study;

Inclusion criteria

  • No diagnosed chronic disease,
  • Healthy adults between the ages of 45-80

Exclusion criteria

  • Individuals with a Mini Mental State Assessment Scale score of less than 24,
  • A smoking history of at least 10 packs×years or more,
  • Having had COVID-19,
  • A BMI of >30 kg/m2

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

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

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

Identifiers

NCT: NCT06948942 · 2024 - 1689

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗