Interstitial Lung DiseaseNCT06141603
Comparison of Upper and Lower Limb Maximal Exercise Capacities and Muscle Oxygenation in Patients With ILD
An observational study of Interstitial Lung Disease, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Interstitial lung diseases (ILD) are a complex group of diseases that cause significant morbidity and mortality, develop diffuse lung parenchyma and alveolar inflammation, as well as interstitial fibrosis, which refers to more than 200 diseases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Interstitial Lung Disease
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Nov 2023to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: 30 patients diagnosed with interstitial lung disease will be recruited.
Who may be able to join
- patients between the ages of 18-75 with interstitial lung disease
Who cannot join
- acute infection during the study
- have an orthopedic or neurological disease that will affect their exercise capacity
- acute exacerbation or any infection
- have contraindications to the exercise test
- an acute respiratory infection
- had Coronavirus-19 (COVID-19) disease in the last 3 months
- have undergone different treatments other than standard medical treatment
Trial locations and contacts
1 site in 1 country.
Beyza Nur ÖYMEZ, Pt. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
Ankara, Çankaya, 06490
Meral BOŞNAK GÜÇLÜ, Prof. Dr., +903122162647, meralbosnak@gazi.edu.tr
Beyza Nur ÖYMEZ, Prof. Dr., beyzanuroymez@gmail.com
About this study
Official title: Comparison of Upper and Lower Limb Maximal Exercise Capacities, Muscle Oxygenation and Energy Consumption During Tests in Patients With Interstitial Lung Disease
Interstitial lung diseases (ILD) are a complex group of diseases that cause significant morbidity and mortality, develop diffuse lung parenchyma and alveolar inflammation, as well as interstitial fibrosis, which refers to more than 200 diseases. Due to restrictive type ventilation disorder and impaired pulmonary gas exchange, pulmonary function has deteriorated in these patients and progressive shortness of breath, fatigue, cough and exercise intolerance are usually observed, which also affects the quality of life.
Read the detailed description
As a result of the chronic inflammatory process of the disease, structural and mechanical pulmonary disorders develop, which are cited as the causes of deterioration in cardiopulmonary functions. In these patients, there is a decrease in static and dynamic lung volumes and carbon monoxide diffusion capacity. As a result of this mechanism, the level of physical activity decreases due to increased shortness of breath during activity. In ILD, there is a decrease in peripheral November muscle strength of both the upper extremities and lower extremities. November it was stated that the weakness of the skeletal muscles of the lower extremities was more pronounced than the skeletal muscles of the upper extremities due to disuse in these patients, and the muscle strength of the upper extremities did not decrease significantly. However, it has been reported that upper limb exercise capacity is worse than lower limb exercise capacity. Arterial hypoxemia is shown as the main reason for the decrease in exercise performance, and peak oxygen consumption (VO2peak) decreased in these patients.
In healthy people, respiratory frequency, tidal volume (VT), minute ventilation and oxygen consumption increase during exercise. In interstitial lung patients, vital capacity decreases at rest, which leads to limitation of VT. Lung compliance decreases and respiratory workload increases. The respiratory workload, which increases even more during exercise, has a bad effect on ventricular function. This causes a lower oxygen pulse and pulse volume in patients during exercise than in healthy individuals.
The primary aim of the study: To compare the maximal exercise capacities and muscle oxygenation during cardiopulmonary exercise tests of upper and lower extremities in patients with interstitial lung disease.
The secondary aim of the study is to compare energy consumption and the perception of dyspnea and fatigue during tests in patients with interstitial lung disease.
The primary outcome will be upper and lower maximal exercise capacities (cardiopulmonary exercise tests) and muscle oxygenation during cardiopulmonary exercise tests (Near-infrared spectroscopy) device).
Secondary outcome will be energy consumption (multi sensor activity device), the perception of dyspnea (Modified Borg Scale (MBS)) and fatigue (MBS).
- Conditions
- Interstitial Lung Disease
- Keywords
- interstitial lung disease, muscle oxygenation, cardiopulmonary exercise testing
- 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 group | Role | What they receive |
|---|---|---|
| Lower Extremity Group | The first test is the cardiopulmonary exercise test (CPET), which evaluates the maximal exercise capacity of the lower extremities and will be performed on a treadmill. During the test, the muscle oxygen of the individuals will be measured with a near-infrared spectrometer, and their energy consumption will be measured with a multisensory physical activity monitor. | |
| Upper Extremity Group | In the second test, the maximal exercise capacity for the upper limb will again be evaluated by CPET and performed on the arm ergometer. The second test will be conducted 48 hours after the lower extremity exercise test. During the test in the second group, as in the first test, muscle oxygen will be measured with a near-infrared spectrometer, and energy expenditure with a multisensory physical activity monitor. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral Muscle Oxygenation
Peripheral muscle oxygen will be measured by near-infrared spectrometry. The device probes will be placed on the upper and lower extremities for both tests.
The device allows to display of the percentage of oxygen, the concentration of oxyhemoglobin, and deoxyhemoglobin, the difference between oxyhemoglobin and deoxyhemoglobin, and the total hemoglobin. These parameters will be evaluated in our study.
Measured: through study completion, an average of 1 year
Secondary outcomes (12)
Maximal Exercise Capacity
Maximal Exercise capacity will be evaluated with Cardiopulmonary Exercise testing. The Cardiopulmonary Exercise Testing will be applied according to American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria.
Measured: through study completion, an average of 1 year
Energy Consumption During Tests
Energy consumption will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient wear the multi sensor physical activity monitor over the triceps muscle of the non-dominant arm during CPETs. Energy consumption (joule / day) will be measured with the multi-sensor physical activity monitor. The measured parameter will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: through study completion, an average of 1 year
Physical Activity Level (Total energy expenditure)
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 4 continuous days. The patient will be informed about removing the device while taking a bath. Total energy expenditure (joule / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: through study completion, an average of 1 year
Physical activity (Active energy expenditure (joule / day))
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 4 continuous days. The patient will be informed about removing the device while taking a bath. Active energy expenditure (joule / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: through study completion, an average of 1 year
Physical activity (Physical activity time (min / day))
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 4 continuous days. The patient will be informed about removing the device while taking a bath. Physical activity time (min / day)will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: through study completion, an average of 1 year
Physical activity (Average metabolic equivalent (MET / day))
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 4 continuous days. The patient will be informed about removing the device while taking a bath. Average metabolic equivalent (MET / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: through study completion, an average of 1 year
Physical activity (Number of steps (steps / day))
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 4 continuous days. The patient will be informed about removing the device while taking a bath. Number of steps (steps / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: through study completion, an average of 1 year
Physical activity (Time spent lying down (min / day) days))
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 4 continuous days. The patient will be informed about removing the device while taking a bath. Time spent lying down (min / day) days) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: through study completion, an average of 1 year
Physical activity (Sleep time (min / day))
Physical activity will be evaluated with the Multi sensor activity monitor (SenseWear®, Inc Pittsburgh, ABD). The patient will wear the multisensor physical activity monitor over the triceps muscle of the non-dominant arm for 4 continuous days. The patient will be informed about removing the device while taking a bath. Sleep time (min / day) will be measured with the multi-sensor physical activity monitor. The parameters measured over two days will be averaged and analyzed with the "SenseWear® 7.0 Software" program.
Measured: through study completion, an average of 1 year
Peripheral Muscle Strength
Isometric peripheral muscle strength will be measured with a portable hand dynamometer (JTECH Commander, USA).
Measurements will be repeated on the shoulder abductors and knee extensors three times on the right and left.
Measured: through study completion, an average of 1 year
Dyspnea
Modified Borg Scale: The Modified Borg scale is a subjective scale that scores 0-10 for breathlessness and fatigue at rest and/or during activity. The lowest 0 points "not at all" the highest 10 points "very severe" means shortness of breath.
Measured: through study completion, an average of 1 year
Fatigue
Fatigue will be measured by the Turkish adaptation of the Fatigue Severity Scale. The Fatigue Severity Scale (FSS) is a scale that evaluates fatigue and consists of 9 questions. Scores can be taken from the scale in the range of 0 to 63 points. Each item is scored between 0 and 7 points. The total score is divided by 9 and if the average is less than 4, there is no fatigue, and if more than 4 points, it is considered that there is fatigue.
Measured: through 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.
- First posted21 Nov 2023
- Study start25 Nov 2023
- Primary completion28 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meral Boşnak Güçlü, Gazi University
- Investigators
- Beyza Nur ÖYMEZ, Pt., Principal investigator, Gazi UniversityNilgün YILMAZ DEMİRCİ, Prof. Dr., Principal investigator, Gazi UniversityMeral BOŞNAK GÜÇLÜ, Prof. Dr., Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06141603
- Sponsor's protocol ID
- Gazi University 28
- Status last verified
- Dec 2023
- First submitted
- 15 Nov 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guler SA, Corte TJ. Interstitial Lung Disease in 2020: A History of Progress. Clin Chest Med. 2021 Jun;42(2):229-239. doi: 10.1016/j.ccm.2021.03.001.
PubMed 34024399Mikolasch TA, Garthwaite HS, Porter JC. Update in diagnosis and management of interstitial lung disease . Clin Med (Lond). 2017 Apr;17(2):146-153. doi: 10.7861/clinmedicine.17-2-146.
PubMed 28365626Molgat-Seon Y, Schaeffer MR, Ryerson CJ, Guenette JA. Exercise Pathophysiology in Interstitial Lung Disease. Clin Chest Med. 2019 Jun;40(2):405-420. doi: 10.1016/j.ccm.2019.02.011.
PubMed 31078218Bourke SJ. Interstitial lung disease: progress and problems. Postgrad Med J. 2006 Aug;82(970):494-9. doi: 10.1136/pgmj.2006.046417.
PubMed 16891438Shen Q, Guo T, Song M, Guo W, Zhang Y, Duan W, Peng Y, Ni S, Ouyang X, Peng H. Pain is a common problem in patients with ILD. Respir Res. 2020 Nov 11;21(1):297. doi: 10.1186/s12931-020-01564-0.
PubMed 33176795Tomlinson OW, Markham L, Wollerton RL, Knight BA, Duckworth A, Gibbons MA, Scotton CJ, Williams CA. Validity and repeatability of cardiopulmonary exercise testing in interstitial lung disease. BMC Pulm Med. 2022 Dec 22;22(1):485. doi: 10.1186/s12890-022-02289-0.
PubMed 36550475Dowman LM, McDonald CF, Hill CJ, Lee AL, Barker K, Boote C, Glaspole I, Goh NSL, Southcott AM, Burge AT, Gillies R, Martin A, Holland AE. The evidence of benefits of exercise training in interstitial lung disease: a randomised controlled trial. Thorax. 2017 Jul;72(7):610-619. doi: 10.1136/thoraxjnl-2016-208638. Epub 2017 Feb 17.
PubMed 28213592Antoniou KM, Margaritopoulos GA, Tomassetti S, Bonella F, Costabel U, Poletti V. Interstitial lung disease. Eur Respir Rev. 2014 Mar 1;23(131):40-54. doi: 10.1183/09059180.00009113.
PubMed 24591661Baydur A. Pulmonary physiology in interstitial lung disease: recent developments in diagnostic and prognostic implications. Curr Opin Pulm Med. 1996 Sep;2(5):370-5. doi: 10.1097/00063198-199609000-00005.
PubMed 9363170Panagiotou M, Church AC, Johnson MK, Peacock AJ. Pulmonary vascular and cardiac impairment in interstitial lung disease. Eur Respir Rev. 2017 Jan 17;26(143):160053. doi: 10.1183/16000617.0053-2016. Print 2017 Jan.
PubMed 28096284Nishiyama O, Yamazaki R, Sano H, Iwanaga T, Higashimoto Y, Kume H, Tohda Y. Physical activity in daily life in patients with idiopathic pulmonary fibrosis. Respir Investig. 2018 Jan;56(1):57-63. doi: 10.1016/j.resinv.2017.09.004. Epub 2017 Oct 23.
PubMed 29325683Mendes P, Wickerson L, Helm D, Janaudis-Ferreira T, Brooks D, Singer LG, Mathur S. Skeletal muscle atrophy in advanced interstitial lung disease. Respirology. 2015 Aug;20(6):953-9. doi: 10.1111/resp.12571. Epub 2015 Jun 17.
PubMed 26081374Harris-Eze AO, Sridhar G, Clemens RE, Zintel TA, Gallagher CG, Marciniuk DD. Role of hypoxemia and pulmonary mechanics in exercise limitation in interstitial lung disease. Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):994-1001. doi: 10.1164/ajrccm.154.4.8887597.
PubMed 8887597Bhambhani Y, Maikala R, Buckley S. Muscle oxygenation during incremental arm and leg exercise in men and women. Eur J Appl Physiol Occup Physiol. 1998 Oct;78(5):422-31. doi: 10.1007/s004210050441.
PubMed 9809843Molgat-Seon Y, Schaeffer MR, Ryerson CJ, Guenette JA. Cardiopulmonary Exercise Testing in Patients With Interstitial Lung Disease. Front Physiol. 2020 Jul 10;11:832. doi: 10.3389/fphys.2020.00832. eCollection 2020.
PubMed 32754054
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Upper and Lower Limb Maximal Exercise Capacities, Muscle Oxygenation and Energy Consumption During Tests in Patients With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT06141603
- Acronym / sponsor ID
- Gazi University 28
- Conditions
- Interstitial Lung Disease
- Keywords
- interstitial lung disease, muscle oxygenation, cardiopulmonary exercise testing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 25 Nov 2023 (actual)
- Primary completion
- 28 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 21 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Interstitial lung diseases (ILD) are a complex group of diseases that cause significant morbidity and mortality, develop diffuse lung parenchyma and alveolar inflammation, as well as interstitial fibrosis, which refers to more than 200 diseases. Due to restrictive type ventilation disorder and impaired pulmonary gas exchange, pulmonary function has deteriorated in these patients and progressive shortness of breath, fatigue, cough and exercise intolerance are usually observed, which also affects the quality of life.
Detailed description
As a result of the chronic inflammatory process of the disease, structural and mechanical pulmonary disorders develop, which are cited as the causes of deterioration in cardiopulmonary functions. In these patients, there is a decrease in static and dynamic lung volumes and carbon monoxide diffusion capacity. As a result of this mechanism, the level of physical activity decreases due to increased shortness of breath during activity. In ILD, there is a decrease in peripheral November muscle strength of both the upper extremities and lower extremities. November it was stated that the weakness of the skeletal muscles of the lower extremities was more pronounced than the skeletal muscles of the upper extremities due to disuse in these patients, and the muscle strength of the upper extremities did not decrease significantly. However, it has been reported that upper limb exercise capacity is worse than lower limb exercise capacity. Arterial hypoxemia is shown as the main reason for the decrease in exercise performance, and peak oxygen consumption (VO2peak) decreased in these patients.
In healthy people, respiratory frequency, tidal volume (VT), minute ventilation and oxygen consumption increase during exercise. In interstitial lung patients, vital capacity decreases at rest, which leads to limitation of VT. Lung compliance decreases and respiratory workload increases. The respiratory workload, which increases even more during exercise, has a bad effect on ventricular function. This causes a lower oxygen pulse and pulse volume in patients during exercise than in healthy individuals.
The primary aim of the study: To compare the maximal exercise capacities and muscle oxygenation during cardiopulmonary exercise tests of upper and lower extremities in patients with interstitial lung disease.
The secondary aim of the study is to compare energy consumption and the perception of dyspnea and fatigue during tests in patients with interstitial lung disease.
The primary outcome will be upper and lower maximal exercise capacities (cardiopulmonary exercise tests) and muscle oxygenation during cardiopulmonary exercise tests (Near-infrared spectroscopy) device).
Secondary outcome will be energy consumption (multi sensor activity device), the perception of dyspnea (Modified Borg Scale (MBS)) and fatigue (MBS).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower Extremity Group | – | –The first test is the cardiopulmonary exercise test (CPET), which evaluates the maximal exercise capacity of the lower extremities and will be performed on a treadmill. During the test, the muscle oxygen of the individuals will be measured with a near-infrared spectrometer, and their energy consumption will be measured with a multisensory physical activity monitor. |
| Upper Extremity Group | – | –In the second test, the maximal exercise capacity for the upper limb will again be evaluated by CPET and performed on the arm ergometer. The second test will be conducted 48 hours after the lower extremity exercise test. During the test in the second group, as in the first test, muscle oxygen will be measured with a near-infrared spectrometer, and energy expenditure with a multisensory physical activity monitor. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients diagnosed with interstitial lung disease will be recruited.
Key inclusion criteria (1 listed)
- patients between the ages of 18-75 with interstitial lung disease
Key exclusion criteria (7 listed)
- acute infection during the study
- have an orthopedic or neurological disease that will affect their exercise capacity
- acute exacerbation or any infection
- have contraindications to the exercise test
- an acute respiratory infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peripheral Muscle Oxygenation
Time frame: through study completion, an average of 1 year
Peripheral muscle oxygen will be measured by near-infrared spectrometry. The device probes will be placed on the upper and lower extremities for both tests. The device allows to display of the percentage of oxygen, the concentration of oxyhemoglobin, and deoxyhemoglobin, the difference between oxyhemoglobin and deoxyhemoglobin, and the total hemoglobin. These parameters will be evaluated in our study.
12 secondary outcomes
Maximal Exercise Capacity
Time frame: through study completion, an average of 1 year
Energy Consumption During Tests
Time frame: through study completion, an average of 1 year
Physical Activity Level (Total energy expenditure)
Time frame: through study completion, an average of 1 year
Physical activity (Active energy expenditure (joule / day))
Time frame: through study completion, an average of 1 year
Physical activity (Physical activity time (min / day))
Time frame: through study completion, an average of 1 year
Physical activity (Average metabolic equivalent (MET / day))
Time frame: through study completion, an average of 1 year
Physical activity (Number of steps (steps / day))
Time frame: through study completion, an average of 1 year
Physical activity (Time spent lying down (min / day) days))
Time frame: through study completion, an average of 1 year
Physical activity (Sleep time (min / day))
Time frame: through study completion, an average of 1 year
Peripheral Muscle Strength
Time frame: through study completion, an average of 1 year
Dyspnea
Time frame: through study completion, an average of 1 year
Fatigue
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Background: PubMed 34024399Guler SA, Corte TJ. Interstitial Lung Disease in 2020: A History of Progress. Clin Chest Med. 2021 Jun;42(2):229-239. doi: 10.1016/j.ccm.2021.03.001.
- Background: PubMed 28365626Mikolasch TA, Garthwaite HS, Porter JC. Update in diagnosis and management of interstitial lung disease . Clin Med (Lond). 2017 Apr;17(2):146-153. doi: 10.7861/clinmedicine.17-2-146.
- Background: PubMed 31078218Molgat-Seon Y, Schaeffer MR, Ryerson CJ, Guenette JA. Exercise Pathophysiology in Interstitial Lung Disease. Clin Chest Med. 2019 Jun;40(2):405-420. doi: 10.1016/j.ccm.2019.02.011.
- Background: PubMed 16891438Bourke SJ. Interstitial lung disease: progress and problems. Postgrad Med J. 2006 Aug;82(970):494-9. doi: 10.1136/pgmj.2006.046417.
- Background: PubMed 33176795Shen Q, Guo T, Song M, Guo W, Zhang Y, Duan W, Peng Y, Ni S, Ouyang X, Peng H. Pain is a common problem in patients with ILD. Respir Res. 2020 Nov 11;21(1):297. doi: 10.1186/s12931-020-01564-0.
- Background: PubMed 36550475Tomlinson OW, Markham L, Wollerton RL, Knight BA, Duckworth A, Gibbons MA, Scotton CJ, Williams CA. Validity and repeatability of cardiopulmonary exercise testing in interstitial lung disease. BMC Pulm Med. 2022 Dec 22;22(1):485. doi: 10.1186/s12890-022-02289-0.
- Background: PubMed 28213592Dowman LM, McDonald CF, Hill CJ, Lee AL, Barker K, Boote C, Glaspole I, Goh NSL, Southcott AM, Burge AT, Gillies R, Martin A, Holland AE. The evidence of benefits of exercise training in interstitial lung disease: a randomised controlled trial. Thorax. 2017 Jul;72(7):610-619. doi: 10.1136/thoraxjnl-2016-208638. Epub 2017 Feb 17.
- Background: PubMed 24591661Antoniou KM, Margaritopoulos GA, Tomassetti S, Bonella F, Costabel U, Poletti V. Interstitial lung disease. Eur Respir Rev. 2014 Mar 1;23(131):40-54. doi: 10.1183/09059180.00009113.
- Background: PubMed 9363170Baydur A. Pulmonary physiology in interstitial lung disease: recent developments in diagnostic and prognostic implications. Curr Opin Pulm Med. 1996 Sep;2(5):370-5. doi: 10.1097/00063198-199609000-00005.
- Background: PubMed 28096284Panagiotou M, Church AC, Johnson MK, Peacock AJ. Pulmonary vascular and cardiac impairment in interstitial lung disease. Eur Respir Rev. 2017 Jan 17;26(143):160053. doi: 10.1183/16000617.0053-2016. Print 2017 Jan.
- Background: PubMed 29325683Nishiyama O, Yamazaki R, Sano H, Iwanaga T, Higashimoto Y, Kume H, Tohda Y. Physical activity in daily life in patients with idiopathic pulmonary fibrosis. Respir Investig. 2018 Jan;56(1):57-63. doi: 10.1016/j.resinv.2017.09.004. Epub 2017 Oct 23.
- Background: PubMed 26081374Mendes P, Wickerson L, Helm D, Janaudis-Ferreira T, Brooks D, Singer LG, Mathur S. Skeletal muscle atrophy in advanced interstitial lung disease. Respirology. 2015 Aug;20(6):953-9. doi: 10.1111/resp.12571. Epub 2015 Jun 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beyza Nur ÖYMEZ, Pt. contact
Beyza Nur ÖYMEZ, Pt. principal investigator
Gazi University
Nilgün YILMAZ DEMİRCİ, Prof. Dr. principal investigator
Gazi University
Meral BOŞNAK GÜÇLÜ, Prof. Dr. study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interstitial Lung Disease, 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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 28 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meral BOŞNAK GÜÇLÜ, Prof. Dr. (03122162647, meralbosnak@gazi.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral Muscle Oxygenation (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06141603, which also lists 33 linked publications.
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 28 Dec 2023.