Clinical trial NCT06141603: Comparison of Upper and Lower Limb Maximal Exercise Capacities and Muscle Oxygenation in Patients With ILD
Official title: Comparison of Upper and Lower Limb Maximal Exercise Capacities, Muscle Oxygenation and Energy Consumption During Tests in Patients With Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Interstitial Lung Disease
Keywords: interstitial lung disease
muscle oxygenation
cardiopulmonary exercise testing
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 patients diagnosed with interstitial lung disease will be recruited.

Brief 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. 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).

Eligibility 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

Primary outcomes:
measure: Peripheral Muscle Oxygenation
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Maximal Exercise Capacity
timeFrame: through study completion, an average of 1 year
measure: Energy Consumption During Tests
timeFrame: through study completion, an average of 1 year
measure: Physical Activity Level (Total energy expenditure)
timeFrame: through study completion, an average of 1 year
measure: Physical activity (Active energy expenditure (joule / day))
timeFrame: through study completion, an average of 1 year
measure: Physical activity (Physical activity time (min / day))
timeFrame: through study completion, an average of 1 year
measure: Physical activity (Average metabolic equivalent (MET / day))
timeFrame: through study completion, an average of 1 year
measure: Physical activity (Number of steps (steps / day))
timeFrame: through study completion, an average of 1 year
measure: Physical activity (Time spent lying down (min / day) days))
timeFrame: through study completion, an average of 1 year
measure: Physical activity (Sleep time (min / day))
timeFrame: through study completion, an average of 1 year
measure: Peripheral Muscle Strength
timeFrame: through study completion, an average of 1 year
measure: Dyspnea
timeFrame: through study completion, an average of 1 year
measure: Fatigue
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit
state: Çankaya
Study officials:
affiliation: Gazi University
name: Beyza Nur ÖYMEZ, Pt.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Nilgün YILMAZ DEMİRCİ, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Meral BOŞNAK GÜÇLÜ, Prof. Dr.
role: STUDY_DIRECTOR
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