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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Exercise Capacity; Healthy Individuals; Muscle Oxygenation; Interstitial Lung Diseases (ILD); Physical Activity Level

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Meral BOŞNAK GÜÇLÜ, Prof. Dr.; Phone Number: +903122162647; Email: meralbosnak@gazi.edu.tr
• Study Contact Backup: Name: Nazire Nur YILDIZ, M.Sc.; Email: nnur_yildiz_58@hotmail.com

Study Locations

• Turkey
  • Ankara, Turkey, 06490
    • Recruiting
    • Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
    • Contact: Meral BOŞNAK GÜÇLÜ, Prof. Dr.; Phone Number: +903122162647; Email: meralbosnak@gazi.edu.tr
    • Principal Investigator: Nazire Nur YILDIZ, M.Sc.
    • Principal Investigator: Meral BOŞNAK GÜÇLÜ, Prof. Dr.
    • Principal Investigator: Beyzanur ÖYMEZ
    • Principal Investigator: Ayşenur GÜVENİR, M.Sc.
    • Principal Investigator: Nilgün YILMAZ DEMİRCİ, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients diagnosed with ILDs and healthy individuals

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper extremity functional exercise capacity	To evaluate upper extremity functional exercise capacity, 6-minute pegboard and ring tests will be applied twice with 15-30 minute intervals. Before the test, individuals will be seated and rested for at least 10 minutes. Individuals will be provided with detailed information about the application of the test before the test. Patients will be informed not to interfere with rings that fall during the test and to continue the test. It will be explained that they can stop and rest if they feel too uncomfortable to continue the test, but this time will be included in the test duration. Before the actual test, subjects will be allowed to move up and down one loop as a practice to learn the test procedure. As a test result, the total number of rings worn at the end of six minutes will be recorded in numbers.	Trough study completion, an average of 1 year
Lower extremity functional exercise capacity	A 6-minute walking test will be applied according to ATS/ERS criteria to evaluate lower extremity functional exercise capacity.	Trough study completion, an average of 1 year
Dyspnea	The assessment of dyspnea at rest, during, and after exercise training will be made with the Modified Borg scale. The Modified Borg scale is a subjective scale and scores the shortness of breath at rest and/or during activity between 0-10. The lowest score of 0 (zero) indicates 'none', and the highest score of 10 (ten) indicates 'maximal' shortness of breath. The Modified Medical Research Council (MMRC) dyspnea scale will be used to determine the perception of dyspnea during activities of daily living. The London Chest Activities of Daily Living Scale, developed by Garrod et al. to examine dyspnea that occurs with daily living activities in chronic obstructive pulmonary disease and whose Turkish validity and reliability were performed by Saka et al., will be used to assess shortness of breath that occurs during activities of daily living.	Trough study completion, an average of 1 year
Respiratory Muscle Strength	Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device.	Trough study completion, an average of 1 year
Inspiratory muscle endurance	The increasing threshold load using the inspiratory muscle training device will be evaluated with the respiratory muscle endurance test. The test will be started with 30% of MIP and the inspiratory threshold load will be increased by 10% of MIP every two minutes. The test will be terminated in the presence of severe dyspnea/fatigue or when patients cannot take three deep breaths in a row. At the end of the test, the respiratory muscle endurance result will be obtained by multiplying the maximal inspiratory pressure (cmH2O) that the patients can maintain for one minute and the total time (seconds).	Trough study completion, an average of 1 year
Peripheral muscle strength	Shoulder abductor and knee extansor muscle strength will be assessed with a portable handheld dynamometer (JTECH Power Track Commander, Baltimore, USA).	Trough study completion, an average of 1 year
Pulmonary function (Forced expiratory volume in the first second (FEV1))	Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced expiratory volume in the first second (FEV1) will be evaluated.	Trough study completion, an average of 1 year
Pulmonary function (Forced vital capacity (FVC))	Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, forced vital capacity (FVC) will be evaluated.	Trough study completion, an average of 1 year
Pulmonary function (FEV1/FVC)	Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, FEV1 / FVC will be evaluated.	Trough study completion, an average of 1 year
Pulmonary function (Flow rate 25-75% of forced expiratory volume (FEF 25-75%))	Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, flow rate 25-75% of forced expiratory volume (FEF 25-75%) will be evaluated.	Trough study completion, an average of 1 year
Pulmonary function (Peak flow rate (PEF))	Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria. With the device, peak flow rate (PEF) will be evaluated.	Trough study completion, an average of 1 year
Disease Related Quality of life	The Saint George Respiratory Questionnaire is a questionnaire used to assess the quality of life in respiratory diseases and its Turkish validity and reliability were conducted by Polatlı et al. The questionnaire consists of 3 sections: symptoms (8 items), activities (16 items), and effects of the disease (26 items) and a total of 50 items: The 3 sections of the test are scored separately. Then, a total score is obtained. The total score varies between 0-100. A score of zero is normal, while a score of 100 indicates maximum disability. As the total score increases, it indicates that the patients' quality of life is poor.	Trough study completion, an average of 1 year
Sleep quality	The Pittsburgh Sleep Quality Index will be used to evaluate the patients' sleep quality. It contains a total of 24 questions. 19 of these questions are answered by the individual by evaluating himself/herself. The remaining 5 questions are answered by the individual's bed partner or roommate, if any. The questionnaire includes questions asked under 7 main headings: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disorders, use of sleeping pills and daytime functions. Each of these 7 main headings is first evaluated within itself. Then, the scores of the 7 components are added. If the total score is over 5 points, it is considered as poor sleep.	Trough study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Gazi University
• Investigators: Study Director: Meral BOŞNAK GÜÇLÜ, Prof. Dr., Gazi University; Principal Investigator: Nilgün YILMAZ DEMİRCİ, Prof. Dr., Gazi University; Principal Investigator: 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

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2024
• Primary Completion (Estimated): July 12, 2025
• Study Completion (Estimated): September 12, 2025

Study Registration Dates

• First Submitted: April 22, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 29, 2025

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Exercise capacity; Healthy individuals; Physical activity level; Interstitial lung diseases; Muscle oxygenation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: 2024 - 1689

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To protect patient data, it will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No