Lung Diseases, InterstitialNCT05855447
Muscles Oxygenation During Exercise in Fibrosing Interstitial Lung Diseases
An observational study of Lung Diseases, Interstitial and Exercise, Compulsive, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The type of this study is an observational prospective study. It will be done to determine the oxygenation status of the intercostal muscles and quadriceps femoris muscle during exercise in patients with fibrosing lung and to examine its relationship with exercise capacity, respiratory functions and respiratory muscle… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Diseases, Interstitial, Exercise, Compulsive, Oxygen Deficiency
- What is being tested?
- NIRS device usage during 6MWT, Peripheral Muscle Strength Measurement and Pulmonary Function Test
- Type of treatment
- Injection or infusion
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Feb 2023to 1 Oct 2023
- 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: The sample of the study will consist of male and female patients between the ages of 18-75 who have been diagnosed with Fibrosing Lung Disease (Interstitial Lung Disease) in Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital.
Who may be able to join
- Being between the ages of 18-75.
- Have a diagnosis of fibrosing interstitial lung disease diagnosed according to the clinical diagnostic criteria of the American Thoracic and European Respiratory Societies (ATS-ERS).
- Presence of dyspnea on exertion Stable clinical state at the time of admission without infection or exacerbation in the previous 4 weeks.
- Ability to use a smart phone.
Who cannot join
- Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and needing high flow oxygen therapy (˃ 3-4 L \min).
- History of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training.
- Participating in a pulmonary rehabilitation program within the past 12 months.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SBU Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul
About this study
Official title: Intercostal and Quadriceps Femoris Muscles Oxygenation During Exercise in Patient With Fibrosing Interstitial Lung Diseases
The type of this study is an observational prospective study. It will be done to determine the oxygenation status of the intercostal muscles and quadriceps femoris muscle during exercise in patients with fibrosing lung and to examine its relationship with exercise capacity, respiratory functions and respiratory muscle strength. The main questions that the study aims to answer are:
- Question 1: Do changes in muscle oxygenation during exercise affect respiratory functions in patients with Fibrosing Lung?
- Question 2: Do changes in muscle oxygenation during exercise affect exercise capacity in patients with Fibrosing Lung?
Participants; demographic information such as age, height, weight will be questioned. Respiratory functions will be evaluated with a desktop spirometer, peripheral muscle strength measurement will be evaluated with a digital myometer, and functional capacity will be evaluated with a 6-minute walk test (6MWT). The Moxy device, which is a non-invasive near-infrared spectroscopy (NIRS), will be attached to the upper leg (the vastus lateralis of the quadriceps muscle) and the rib (intercostal muscles) with a silk patch, and the oxygenation of the muscles here will be measured during the 6-minute walking test. In addition, fatigue status will be evaluated with the Modified Borg Scale.
Read the detailed description
Interstitial Lung Disease (ILD); It constitutes a heterogeneous group of approximately 200 diseases with acute or chronic course that affect the lung diffusely and cause varying degrees of inflammation, fibrosis and structural deterioration in the lung parenchyma. Clinical features of ILD include exercise-induced dyspnea, exercise-induced hypoxemia, progressive skeletal muscle weakness, and impaired exercise tolerance. The main symptoms of fibrosis are progressive decreases in forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLCO). Restriction of pulmonary ventilation leads to respiratory failure, which is exacerbated by capillary destruction and decreased alveolar blood flow resulting from hypoxic vasoconstriction.
Exercise intolerance is a key feature of ILD and is usually associated with significant dyspnea on exertion. Exercise limitation in ILD is related to altered respiratory mechanics, impaired gas exchange, and circulatory limitation. Evidence suggests that pulmonary rehabilitation can provide significant benefits in patients with ILD. Daily use of corticosteroids for >1 year significantly reduces muscle function in patients with chronic respiratory disease. Muscle size, strength, and functional outcomes were evaluated in ILD patients. Decreased quadriceps strength and endurance were seen in patients with fibrotic idiopathic interstitial pneumonia compared to healthy controls. Compared to the upper extremity, more atrophy and weakness were found in the lower extremity muscles. Therefore, exercise training is a critical component of pulmonary rehabilitation. The effect of exercise on blood oxygenation has been little studied in ILD patients, and the few data available in the literature are conflicting.
In the studies conducted, there are studies stating that there is a positive improvement in blood biochemistry as a result of an acute exercise, as well as a change with chronic exercises. An important goal of hemodynamic monitoring is the early detection of inadequate tissue perfusion and oxygenation. The use of simple, non-invasive monitoring techniques has the advantage of facilitating earlier initiation of therapy. Near-infrared spectroscopy (NIRS) is a noninvasive measurement instrument that does not impair skin integrity, allowing the measurement of muscle hemoglobin-oxygen saturation (StO2) during exercise. There are few studies in the literature where muscle oxygenation was measured with the NIRS device. According to the results of our literature review, our study will be the first study to examine muscle oxygenation in fibrosing lung patients.
- Being tested
- NIRS device usage during 6MWT, Peripheral Muscle Strength Measurement, Pulmonary Function Test
- Keywords
- Oxygen Consumption, Interstitial Lung Diseases, Exercise
- Medical subject headings
- Lung Diseases, Interstitial, Compulsive Exercise, Hypoxia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRS device usage during 6MWTOther
It will be performed by placing a traffic cone as the sign of the turning point in a straight 30 meter long corridor, after patients have rested for a sufficient time (> 30 minutes) by sitting in a chair. Participants will be asked to walk as fast as possible but without running along the corridor within 6 minutes. Before and after the test, the patient's fatigue and dyspnea conditions will be questioned using the Modified Borg Scale and blood pressure using a digital sphygmomanometer, and saturation and pulse measurement will be evaluated using finger pulse oximetry before, during and after the test. During the 6-minute walk test, the muscle oxygenation of the patients and the amount of muscle oxygen will be measured using Moxy (Fortiori Design LLC, Minnesota, USA) brand NIRS technology. During the walking test, the change in intramuscular oxygenation will be monitored and recorded with the company's software program.
Peripheral Muscle Strength MeasurementOther
The muscle strength of shoulder flexors, abductors, elbow flexors, hip flexors, abductors, and knee extensors will be evaluated using a Lafayette® 01165 model electronic hand dynamometer. The force measurement will be repeated 3 times and it will be requested to maintain muscle strength against the dynamometer for at least 5 seconds in each trial. The best value out of 3 test results will be recorded
Pulmonary Function TestOther
Pulmonary Function Test (PFT) with desktop type spirometry for FVC (Forced Vital Capacity), Forced expiratory flow rate (FEV1), FEV1/FVC.
| Study group | Role | What they receive |
|---|---|---|
| Fibrosing Lung Disease Group | It will consist of 36 patients diagnosed with ILD. The patients whose demographic information such as age, height and weight will be questioned will then be evaluated with a desktop spirometer, peripheral muscle strength measurement with a digital myometer, and functional capacity with a 6MWT. The Moxy device, which is a NIRS, will be attached to the upper leg (the vastus lateralis of the quadriceps muscle) and the rib (intercostal muscles) with a silk patch, and the oxygenation of the muscles here will be measured during the 6MWT. In addition, fatigue status will be evaluated with the Modified Borg Scale. Receives: Other: NIRS device usage during 6MWT; Other: Peripheral Muscle Strength Measurement; Other: Pulmonary Function Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative Muscle Oxygenation Changes with Moxy Muscle Oxygenation Monitor (SmO2)
The measurement will be made in the dominant lower extremity, and the device will be measured by placing the device at a distance of 5 cm from the anterior superior reference point of the spina iliaca to the mid-thigh region of the midpoint of the patella, the intersection of the sixth and eighth intercostal spaces, and the anterior axillary line. Relative muscle oxygenation changes (SmO2) and total hemoglobin concentration according to the modified Beer-Lambert Law formula (SmO2 = (Hb +) by comparing the measured light intensities with a pre-computed data set obtained by a Monte Carlo (MC). O2Mb) ÷ [(O2Hb + O2Mb) + (HHb + HMb)]) percent SmO2 concentration is determined by the diffusion of light in tissue layers.
Measured: Through study completion, an average of 1 year
Total Hemoglobin Concentration with Muscle Oxygenation Monitor (SmO2)
The measurement will be made in the dominant lower extremity, and the device will be measured by placing the device at a distance of 5 cm from the anterior superior reference point of the spina iliaca to the mid-thigh region of the midpoint of the patella, the intersection of the sixth and eighth intercostal spaces, and the anterior axillary line. Relative muscle oxygenation changes (SmO2) and total hemoglobin concentration according to the modified Beer-Lambert Law formula (SmO2 = (Hb +) by comparing the measured light intensities with a pre-computed data set obtained by a Monte Carlo (MC). O2Mb) ÷ [(O2Hb + O2Mb) + (HHb + HMb)]) percent SmO2 concentration is determined by the diffusion of light in tissue layers.
Measured: Through study completion, an average of 1 year
Secondary outcomes (8)
Digital Muscle Strength Measurement for Peripheral Muscle Strength
Muscle strength of shoulder flexors, abductors, elbow flexors, hip flexors, abductors, and knee extensors will be evaluated. The test will be done by Lafayette brand digital muscle strength meter.
Measured: Before 6MWT
Pulmonary Function Test for FVC
Pulmonary function test will be performed with desktop type spirometry. The FVC value will be calculated.
Measured: Before 6MWT
Pulmonary Function Test for FEV1
Pulmonary function test will be performed with desktop type spirometry. The FEV1 value will be calculated.
Measured: Before 6MWT
Pulmonary Function Test for FEV1/FVC
Pulmonary function test will be performed with desktop type spirometry. The FEV1/FVC value will be calculated.
Measured: Before 6MWT
Maximal Inspiratory Muscle Strength
Pulmonary function test will be performed with desktop type spirometry. The Maximal Inspiratory Pressure value will be calculated.
Measured: Before 6MWT
Maximal Expiratory Muscle Strength
Pulmonary function test will be performed with desktop type spirometry. The Maximal Expiratory Pressure value will be calculated.
Measured: Before 6MWT
Fatigue measured with the Modified Borg Scale
Fatigue severity will be measured with the Modified Borg Scale. In the scale, the severity of fatigue is measured with a score between 0 and 10 points. On this scale, 0 point defines the best condition in terms of fatigue, and 10 points the worst.
Measured: Before 6MWT
Dyspnea measured with the Modified Borg Scale
Dyspnea severity will be measured with the Modified Borg Scale. In the scale, the severity of dyspnea is measured with a score between 0 and 10 points. On this scale, 0 point defines the best condition in terms of dyspnea, and 10 points the worst.
Measured: Before 6MWT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start13 Feb 2023
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Diseases, InterstitialStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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 only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esra PEHLİVAN, Assoc. Prof., Principal investigator, Saglik Bilimleri UniversitesiErdoğan ÇETİNKAYA, Prof. Dr., Study director, Saglik Bilimleri UniversitesiZeynep Betül ÖZCAN, M. Sc., Study chair, Saglik Bilimleri UniversitesiFulya Senem KARAAHMETOĞLU, M. Sc., Study chair, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855447
- Sponsor's protocol ID
- Fibrozan_Moxy_1
- Status last verified
- Feb 2023
- First submitted
- 17 Apr 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intercostal and Quadriceps Femoris Muscles Oxygenation During Exercise in Patient With Fibrosing Interstitial Lung Diseases
- ClinicalTrials.gov ID
- NCT05855447
- Acronym / sponsor ID
- Fibrozan_Moxy_1
- Keywords
- Oxygen Consumption, Interstitial Lung Diseases, Exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 11 May 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.
The type of this study is an observational prospective study. It will be done to determine the oxygenation status of the intercostal muscles and quadriceps femoris muscle during exercise in patients with fibrosing lung and to examine its relationship with exercise capacity, respiratory functions and respiratory muscle strength. The main questions that the study aims to answer are:
- Question 1: Do changes in muscle oxygenation during exercise affect respiratory functions in patients with Fibrosing Lung?
- Question 2: Do changes in muscle oxygenation during exercise affect exercise capacity in patients with Fibrosing Lung?
Participants; demographic information such as age, height, weight will be questioned. Respiratory functions will be evaluated with a desktop spirometer, peripheral muscle strength measurement will be evaluated with a digital myometer, and functional capacity will be evaluated with a 6-minute walk test (6MWT). The Moxy device, which is a non-invasive near-infrared spectroscopy (NIRS), will be attached to the upper leg (the vastus lateralis of the quadriceps muscle) and the rib (intercostal muscles) with a silk patch, and the oxygenation of the muscles here will be measured during the 6-minute walking test. In addition, fatigue status will be evaluated with the Modified Borg Scale.
Detailed description
Interstitial Lung Disease (ILD); It constitutes a heterogeneous group of approximately 200 diseases with acute or chronic course that affect the lung diffusely and cause varying degrees of inflammation, fibrosis and structural deterioration in the lung parenchyma. Clinical features of ILD include exercise-induced dyspnea, exercise-induced hypoxemia, progressive skeletal muscle weakness, and impaired exercise tolerance. The main symptoms of fibrosis are progressive decreases in forced vital capacity (FVC) and diffusing capacity of the lung for carbon monoxide (DLCO). Restriction of pulmonary ventilation leads to respiratory failure, which is exacerbated by capillary destruction and decreased alveolar blood flow resulting from hypoxic vasoconstriction.
Exercise intolerance is a key feature of ILD and is usually associated with significant dyspnea on exertion. Exercise limitation in ILD is related to altered respiratory mechanics, impaired gas exchange, and circulatory limitation. Evidence suggests that pulmonary rehabilitation can provide significant benefits in patients with ILD. Daily use of corticosteroids for >1 year significantly reduces muscle function in patients with chronic respiratory disease. Muscle size, strength, and functional outcomes were evaluated in ILD patients. Decreased quadriceps strength and endurance were seen in patients with fibrotic idiopathic interstitial pneumonia compared to healthy controls. Compared to the upper extremity, more atrophy and weakness were found in the lower extremity muscles. Therefore, exercise training is a critical component of pulmonary rehabilitation. The effect of exercise on blood oxygenation has been little studied in ILD patients, and the few data available in the literature are conflicting.
In the studies conducted, there are studies stating that there is a positive improvement in blood biochemistry as a result of an acute exercise, as well as a change with chronic exercises. An important goal of hemodynamic monitoring is the early detection of inadequate tissue perfusion and oxygenation. The use of simple, non-invasive monitoring techniques has the advantage of facilitating earlier initiation of therapy. Near-infrared spectroscopy (NIRS) is a noninvasive measurement instrument that does not impair skin integrity, allowing the measurement of muscle hemoglobin-oxygen saturation (StO2) during exercise. There are few studies in the literature where muscle oxygenation was measured with the NIRS device. According to the results of our literature review, our study will be the first study to examine muscle oxygenation in fibrosing lung patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fibrosing Lung Disease Group | – | Other: NIRS device usage during 6MWT, Other: Peripheral Muscle Strength Measurement, Other: Pulmonary Function TestIt will consist of 36 patients diagnosed with ILD. The patients whose demographic information such as age, height and weight will be questioned will then be evaluated with a desktop spirometer, peripheral muscle strength measurement with a digital myometer, and functional capacity with a 6MWT. The Moxy device, which is a NIRS, will be attached to the upper leg (the vastus lateralis of the quadriceps muscle) and the rib (intercostal muscles) with a silk patch, and the oxygenation of the muscles here will be measured during the 6MWT. In addition, fatigue status will be evaluated with the Modified Borg Scale. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The sample of the study will consist of male and female patients between the ages of 18-75 who have been diagnosed with Fibrosing Lung Disease (Interstitial Lung Disease) in Istanbul Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital.
Key inclusion criteria (4 listed)
- Being between the ages of 18-75.
- Have a diagnosis of fibrosing interstitial lung disease diagnosed according to the clinical diagnostic criteria of the American Thoracic and European Respiratory Societies (ATS-ERS).
- Presence of dyspnea on exertion Stable clinical state at the time of admission without infection or exacerbation in the previous 4 weeks.
- Ability to use a smart phone.
Key exclusion criteria (3 listed)
- Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and needing high flow oxygen therapy (˃ 3-4 L \min).
- History of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training.
- Participating in a pulmonary rehabilitation program within the past 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRS device usage during 6MWTIt will be performed by placing a traffic cone as the sign of the turning point in a straight 30 meter long corridor, after patients have rested for a sufficient time (> 30 minutes) by sitting in a chair. Participants will be asked to walk as fast as possible but without running along the corridor within 6 minutes. Before and after the test, the patient's fatigue and dyspnea conditions will be questioned using the Modified Borg Scale and blood pressure using a digital sphygmomanometer, and saturation and pulse measurement will be evaluated using finger pulse oximetry before, during and after the test. During the 6-minute walk test, the muscle oxygenation of the patients and the amount of muscle oxygen will be measured using Moxy (Fortiori Design LLC, Minnesota, USA) brand NIRS technology. During the walking test, the change in intramuscular oxygenation will be monitored and recorded with the company's software program. | Other | Fibrosing Lung Disease Group |
| Peripheral Muscle Strength MeasurementThe muscle strength of shoulder flexors, abductors, elbow flexors, hip flexors, abductors, and knee extensors will be evaluated using a Lafayette® 01165 model electronic hand dynamometer. The force measurement will be repeated 3 times and it will be requested to maintain muscle strength against the dynamometer for at least 5 seconds in each trial. The best value out of 3 test results will be recorded | Other | Fibrosing Lung Disease Group |
| Pulmonary Function TestPulmonary Function Test (PFT) with desktop type spirometry for FVC (Forced Vital Capacity), Forced expiratory flow rate (FEV1), FEV1/FVC. | Other | Fibrosing Lung Disease Group |
Primary outcome
Relative Muscle Oxygenation Changes with Moxy Muscle Oxygenation Monitor (SmO2)
Time frame: Through study completion, an average of 1 year
The measurement will be made in the dominant lower extremity, and the device will be measured by placing the device at a distance of 5 cm from the anterior superior reference point of the spina iliaca to the mid-thigh region of the midpoint of the patella, the intersection of the sixth and eighth intercostal spaces, and the anterior axillary line. Relative muscle oxygenation changes (SmO2) and total hemoglobin concentration according to the modified Beer-Lambert Law formula (SmO2 = (Hb +) by comparing the measured light intensities with a pre-computed data set obtained by a Monte Carlo (MC). O2Mb) ÷ [(O2Hb + O2Mb) + (HHb + HMb)]) percent SmO2 concentration is determined by the diffusion of light in tissue layers.
Total Hemoglobin Concentration with Muscle Oxygenation Monitor (SmO2)
Time frame: Through study completion, an average of 1 year
The measurement will be made in the dominant lower extremity, and the device will be measured by placing the device at a distance of 5 cm from the anterior superior reference point of the spina iliaca to the mid-thigh region of the midpoint of the patella, the intersection of the sixth and eighth intercostal spaces, and the anterior axillary line. Relative muscle oxygenation changes (SmO2) and total hemoglobin concentration according to the modified Beer-Lambert Law formula (SmO2 = (Hb +) by comparing the measured light intensities with a pre-computed data set obtained by a Monte Carlo (MC). O2Mb) ÷ [(O2Hb + O2Mb) + (HHb + HMb)]) percent SmO2 concentration is determined by the diffusion of light in tissue layers.
8 secondary outcomes
Digital Muscle Strength Measurement for Peripheral Muscle Strength
Time frame: Before 6MWT
Pulmonary Function Test for FVC
Time frame: Before 6MWT
Pulmonary Function Test for FEV1
Time frame: Before 6MWT
Pulmonary Function Test for FEV1/FVC
Time frame: Before 6MWT
Maximal Inspiratory Muscle Strength
Time frame: Before 6MWT
Maximal Expiratory Muscle Strength
Time frame: Before 6MWT
Fatigue measured with the Modified Borg Scale
Time frame: Before 6MWT
Dyspnea measured with the Modified Borg Scale
Time frame: Before 6MWT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
Related trials for Lung Diseases, Interstitial
RecruitingPhase 2
Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Single-Cell Sequencing Analysis of Radiation Pneumonitis Signals In Patients Treated For Cancer With Radiotherapy
Radiation Pneumonitis
RecruitingPhase 2
Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease
Fibrotic Interstitial Lung Disease
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.
Esra PEHLİVAN, Assoc. Prof. principal investigator
Saglik Bilimleri Universitesi
Erdoğan ÇETİNKAYA, Prof. Dr. study director
Saglik Bilimleri Universitesi
Zeynep Betül ÖZCAN, M. Sc. study chair
Saglik Bilimleri Universitesi
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 Lung Diseases, Interstitial and Exercise, Compulsive, run by Saglik Bilimleri Universitesi 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 27 Nov 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative Muscle Oxygenation Changes with Moxy Muscle Oxygenation Monitor (SmO2) (time frame: Through study completion, an average of 1 year). The study lists 2 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 27 Nov 2023.