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Comparison of Upper and Lower Limb Maximal Exercise Capacities and Muscle Oxygenation in Patients With ILD

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- patients between the ages of 18-75 with interstitial lung disease.

Exclusion Criteria:

- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06141603
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Gazi University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Beyza Nur ÖYMEZ, Pt.Nilgün YILMAZ DEMİRCİ, Prof. Dr.Meral BOŞNAK GÜÇLÜ, Prof. Dr.
Principal Investigator Affiliation	Gazi UniversityGazi UniversityGazi University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Turkey
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Interstitial Lung Disease

Additional Details

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).

Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

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