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

NCT ID: NCT06948942

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-12

Study Completion Date

2025-09-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Interstitial Lung Diseases (ILD) Healthy Individuals Exercise Capacity Muscle Oxygenation Physical Activity Level

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Patients with ILD

That group consists of patients who had been diagnosed with ILD by doctors. Oxygen consumption using CPET, muscle oxygenation with a near-infrared spectroscopy device, physical activity level using multi-sensor activity monitor, pulmonary function using spirometer, lower extremity functional exercise capacity with 6MWT, upper-extremity functional exercise capacity with 6PBRT, respiratory muscle strength using mouth pressure device, peripheral muscle strength with hand-held dynamometer, inspiratory muscle endurance using incremental threshold loading test, dyspnea with 'Modified Medical Research Council' Dyspnea Scale and 'Turkish version of London Chest Daily Living Activity Scale', dyspnea at rest, during, and after exercise training with 'Modified Borg Scale', disease-related quality of life with 'Turkish version of Saint George Respiratory Questionnaire' and sleep quality with 'Pittsburg Sleep Quality Index' will be evaluated in patients with ILD.

No interventions assigned to this group

Healthy Controls

That group consists of people who have not been diagnosed with a disease. Oxygen consumption using CPET, muscle oxygenation with a near-infrared spectroscopy device, physical activity level using multi-sensor activity monitor, pulmonary function using spirometer, lower extremity functional exercise capacity with 6MWT, upper-extremity functional exercise capacity with 6PBRT, respiratory muscle strength using mouth pressure device, peripheral muscle strength with hand-held dynamometer, inspiratory muscle endurance using incremental threshold loading test, dyspnea with 'Modified Medical Research Council' Dyspnea Scale and 'Turkish version of London Chest Daily Living Activity Scale', dyspnea at rest, during, and after exercise training with 'Modified Borg Scale', disease-related quality of life with 'Turkish version of Saint George Respiratory Questionnaire' and sleep quality with 'Pittsburg Sleep Quality Index' will be evaluated in healthy controls.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.


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

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;


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gazi University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Meral Boşnak Güçlü

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

Role: STUDY_DIRECTOR

Gazi University

Nazire Nur YILDIZ, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Nigde Omer Halisdemir University

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Beyzanur ÖYMEZ

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Ayşenur GÜVENİR, M.Sc.

Role: PRINCIPAL_INVESTIGATOR

Yozgat Bozok University

Nilgün YILMAZ DEMİRCİ, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Gazi University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

Role: CONTACT

+903122162647

Nazire Nur YILDIZ, M.Sc.

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

Role: primary

+903122162647

Related Links

Access external resources that provide additional context or updates about the study.

https://pubmed.ncbi.nlm.nih.gov/20369109/

Ward J, McDonald C. Interstitial lung disease - An approach to diagnosis and management. Aust Fam Physician. 2010;39(3):106-10. PubMed PMID: 20369109.

https://pubmed.ncbi.nlm.nih.gov/31530430/

Cakmak A, Inal-Ince D, Sonbahar-Ulu H, Bozdemir-Ozel C, Ozalp O, Calik-Kutukcu E, et al. Physical activity of patients with bronchiectasis compared with healthy counterparts: A cross-sectional study. Heart Lung. 2020;49(1):99-104. Epub 20190914. doi: 10.

https://pubmed.ncbi.nlm.nih.gov/26241869/

Arikan H, Yatar I, Calik-Kutukcu E, Aribas Z, Saglam M, Vardar-Yagli N, et al. A comparison of respiratory and peripheral muscle strength, functional exercise capacity, activities of daily living and physical fitness in patients with cystic fibrosis and

https://pubmed.ncbi.nlm.nih.gov/38018157/

Fırat M, Mutlu Ş, Yoleri B, Boşnak Güçlü M. Comparison of respiratory functions, muscle strength, and physical activity among children with primary ciliary dyskinesia with and without Kartagener's syndrome and healthy controls. Physiother Theory Pract. 2

https://pubmed.ncbi.nlm.nih.gov/38272247/

Garcia T, Mantoani LC, Silva H, Zamboti CL, Ribeiro M, Ramos EMC, et al. Characteristics of Skeletal Muscle Strength in Subjects With Interstitial Lung Disease. Arch Phys Med Rehabil. 2024;105(6):1099-105. Epub 20240124. doi: 10.1016/j.apmr.2024.01.006.

https://pubmed.ncbi.nlm.nih.gov/23928896/

Wallaert B, Monge E, Le Rouzic O, Wémeau-Stervinou L, Salleron J, Grosbois J-M. Physical activity in daily life of patients with fibrotic idiopathic interstitial pneumonia. Chest. 2013;144(5):1652-8.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024 - 1689

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.