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Interstitial Lung Diseases (ILD)NCT06948942

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

An observational study of Interstitial Lung Diseases (ILD) and Healthy Individuals, run by Gazi University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
How many people
40 participants
Where
1 siteTurkey (Türkiye)
Study dates
12 Dec 2024to 12 Sep 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients diagnosed with ILDs and healthy individuals

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Meral BOŞNAK GÜÇLÜ, Prof. Dr. contact

+903122162647

meralbosnak@gazi.edu.tr

Nazire Nur YILDIZ, M.Sc. contact

nnur_yildiz_58@hotmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Gazi University Faculty of Health Sciences Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit

    Ankara, 06490

    Meral BOŞNAK GÜÇLÜ, Prof. Dr., +903122162647, meralbosnak@gazi.edu.tr

    Nazire Nur YILDIZ, M.Sc.

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Keywords
Interstitial lung diseases, Healthy individuals, Exercise capacity, Muscle oxygenation, Physical activity level
Medical subject headings
Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06948942
Study groupRoleWhat they receive
Patients with ILDThat 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 ControlsThat 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Trough study completion, an average of 1 year

  2. Muscle Oxygenation

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

    Measured: Trough study completion, an average of 1 year

  3. Physical Activity Level

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

    Measured: Trough study completion, an average of 1 year

Secondary outcomes (13)
  1. 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.

    Measured: Trough study completion, an average of 1 year

  2. 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.

    Measured: Trough study completion, an average of 1 year

  3. 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.

    Measured: Trough study completion, an average of 1 year

  4. Respiratory Muscle Strength

    Maximal inspiratory and expiratory muscle strength will be evaluated using mouth pressure device.

    Measured: Trough study completion, an average of 1 year

  5. 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).

    Measured: Trough study completion, an average of 1 year

  6. Peripheral muscle strength

    Shoulder abductor and knee extansor muscle strength will be assessed with a portable handheld dynamometer (JTECH Power Track Commander, Baltimore, USA).

    Measured: Trough study completion, an average of 1 year

  7. 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.

    Measured: Trough study completion, an average of 1 year

  8. 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.

    Measured: Trough study completion, an average of 1 year

  9. 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.

    Measured: Trough study completion, an average of 1 year

  10. 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.

    Measured: Trough study completion, an average of 1 year

  11. 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.

    Measured: Trough study completion, an average of 1 year

  12. 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.

    Measured: Trough study completion, an average of 1 year

  13. 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.

    Measured: Trough study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2025
  2. Study start12 Dec 2024
  3. Primary completion12 Jul 2025 (estimated)
  4. Study completion12 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06948942
Sponsor's protocol ID
2024 - 1689
Status last verified
Feb 2025
First submitted
22 Apr 2025
Last updated
29 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To protect patient data, it will not be shared.

Questions about this trial

What is this clinical trial studying?

An observational study of Interstitial Lung Diseases (ILD) and Healthy Individuals, run by Gazi University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Meral BOŞNAK GÜÇLÜ, Prof. Dr. (+903122162647, meralbosnak@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximal exercise capacity (time frame: Trough study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.

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