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

NCT06948942 | Recruiting

• 1 other identifier: 2024 - 1689
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (3)

• Maximal exercise capacity

  Maximal exercise capacity will be assessed by symptom-limited cardiopulmonary exercise testing on a treadmill at gradually increasing workload, and oxygen consumption will be measured during the test.

  Trough study completion, an average of 1 year

• Muscle Oxygenation

  Muscle oxygenation before, during and after exercise tests will be measured with a near-infrared spectroscopy device.

  Trough study completion, an average of 1 year

• Physical Activity Level

  Individuals' physical activity level will be assessed with a multi-sensor physical activity monitor.

  Trough study completion, an average of 1 year

Secondary Outcomes (13)

• Upper extremity functional exercise capacity

  Trough study completion, an average of 1 year

• Lower extremity functional exercise capacity

  Trough study completion, an average of 1 year

• Dyspnea

  Trough study completion, an average of 1 year

• Respiratory Muscle Strength

  Trough study completion, an average of 1 year

• Inspiratory muscle endurance

  Trough study completion, an average of 1 year

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: Female and Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with ILDs and healthy individuals

You may qualify if:

• 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.

You may not qualify if:

• 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;
• No diagnosed chronic disease,
• Healthy adults between the ages of 45-80
• Individuals with a Mini Mental State Assessment Scale score of less than 24,
• A smoking history of at least 10 packs×years or more,

Sponsors & Collaborators

• Gazi University: lead

Study Sites (1)

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

Ankara, 06490, Turkey (Türkiye)

RECRUITING

Related Links

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

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Meral BOŞNAK GÜÇLÜ, Prof. Dr.

  Gazi University

  STUDY DIRECTOR

• Nazire Nur YILDIZ, M.Sc.

  Nigde Omer Halisdemir University

  PRINCIPAL INVESTIGATOR

• Meral BOŞNAK GÜÇLÜ, Prof. Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

• Beyzanur ÖYMEZ

  Gazi University

  PRINCIPAL INVESTIGATOR

• Ayşenur GÜVENİR, M.Sc.

  Yozgat Bozok University

  PRINCIPAL INVESTIGATOR

• Nilgün YILMAZ DEMİRCİ, Prof. Dr.

  Gazi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meral BOŞNAK GÜÇLÜ, Prof. Dr.

CONTACT

+903122162647; meralbosnak@gazi.edu.tr

Nazire Nur YILDIZ, M.Sc.

CONTACT

nnur_yildiz_58@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: December 12, 2024
• Primary Completion: July 12, 2025
• Study Completion: September 12, 2025
• Last Updated: April 29, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)