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

Interstitial Lung Disease Clinical Trial

Official title:

Comparison of Upper and Lower Limb Maximal Exercise Capacities, Muscle Oxygenation and Energy Consumption During Tests in Patients With Interstitial Lung Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06141603
• Other study ID #: Gazi University 28
• Status: Recruiting
• Start date: November 25, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: December 2023
• Source: Gazi University
• Contact: Meral BOSNAK GÜÇLÜ, Prof. Dr.
• Phone: 03122162647
• Email: meralbosnak[@]gazi.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2024
• Est. primary completion date: December 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Locations

Country	Name	City	State
Turkey	Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation, Cardiopulmonary Rehabilitation Unit	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (33)

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* Note: There are 33 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year