Muscles Oxygenation During Exercise in Fibrosing Interstitial Lung Diseases
NCT ID: NCT05855447
Last Updated: 2023-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
36 participants
OBSERVATIONAL
2023-02-13
2023-10-01
Brief Summary
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* 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
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
NIRS device usage during 6MWT
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 Measurement
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 Test
Pulmonary Function Test (PFT) with desktop type spirometry for FVC (Forced Vital Capacity), Forced expiratory flow rate (FEV1), FEV1/FVC.
Interventions
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NIRS device usage during 6MWT
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 Measurement
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 Test
Pulmonary Function Test (PFT) with desktop type spirometry for FVC (Forced Vital Capacity), Forced expiratory flow rate (FEV1), FEV1/FVC.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Saglik Bilimleri Universitesi
OTHER
Responsible Party
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Principal Investigators
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Esra PEHLİVAN, Assoc. Prof.
Role: PRINCIPAL_INVESTIGATOR
Saglik Bilimleri Universitesi
Erdoğan ÇETİNKAYA, Prof. Dr.
Role: STUDY_DIRECTOR
Saglik Bilimleri Universitesi
Zeynep Betül ÖZCAN, M. Sc.
Role: STUDY_CHAIR
Saglik Bilimleri Universitesi
Fulya Senem KARAAHMETOĞLU, M. Sc.
Role: STUDY_CHAIR
Saglik Bilimleri Universitesi
Locations
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SBU Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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Fibrozan_Moxy_1
Identifier Type: -
Identifier Source: org_study_id