Clinical trial NCT06948942: Exercise Capacity, Muscle Oxygenation, and Physical Activity Between Patients With Interstitial Lung Disease
Official title: Comparison of Exercise Capacity, Muscle Oxygenation and Physical Activity Levels Between Patients With Interstitial Lung Disease and Healthy Individuals
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interstitial Lung Diseases (ILD)
Healthy Individuals
Exercise Capacity
Muscle Oxygenation
Physical Activity Level
Keywords: Interstitial lung diseases
Healthy individuals
Exercise capacity
Muscle oxygenation
Physical activity level
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with ILDs and healthy individuals

Brief summary: 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.

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

Primary outcomes:
measure: Maximal exercise capacity
timeFrame: Trough study completion, an average of 1 year
measure: Muscle Oxygenation
timeFrame: Trough study completion, an average of 1 year
measure: Physical Activity Level
timeFrame: Trough study completion, an average of 1 year
Secondary outcomes:
measure: Upper extremity functional exercise capacity
timeFrame: Trough study completion, an average of 1 year
measure: Lower extremity functional exercise capacity
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: Inspiratory muscle endurance
timeFrame: Trough study completion, an average of 1 year
measure: Peripheral muscle strength
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 1 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: Disease Related Quality of life
timeFrame: Trough study completion, an average of 1 year
measure: Sleep quality
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: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Meral BOŞNAK GÜÇLÜ, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Beyzanur ÖYMEZ
role: PRINCIPAL_INVESTIGATOR
affiliation: Yozgat Bozok University
name: Ayşenur GÜVENİR, M.Sc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Nilgün YILMAZ DEMİRCİ, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: