Muscles Oxygenation During Exercise in Fibrosing Interstitial Lung Diseases

NCT05855447 | Completed

• 1 other identifier: Fibrozan_Moxy_1
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Lung Diseases, Interstitial; Exercise, Compulsive; Oxygen Deficiency

Keywords

Oxygen Consumption; Interstitial Lung Diseases; Exercise

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Through study completion, an average of 1 year

Secondary Outcomes (8)

• Digital Muscle Strength Measurement for Peripheral Muscle Strength

  Before 6MWT

• Pulmonary Function Test for FVC

  Before 6MWT

• Pulmonary Function Test for FEV1

  Before 6MWT

• Pulmonary Function Test for FEV1/FVC

  Before 6MWT

• Maximal Inspiratory Muscle Strength

  Before 6MWT

Study Arms (1)

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.

Other: NIRS device usage during 6MWT; Other: Peripheral Muscle Strength Measurement; Other: Pulmonary Function Test

Interventions

NIRS device usage during 6MWT OTHER

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.

Fibrosing Lung Disease Group

Peripheral Muscle Strength Measurement OTHER

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

Fibrosing Lung Disease Group

Pulmonary Function Test OTHER

Pulmonary Function Test (PFT) with desktop type spirometry for FVC (Forced Vital Capacity), Forced expiratory flow rate (FEV1), FEV1/FVC.

Fibrosing Lung Disease Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

SBU Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial; Compulsive Exercise; Hypoxia; Motor Activity

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Behavior, Addictive; Compulsive Behavior; Impulsive Behavior; Behavior; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Officials

• Esra PEHLİVAN, Assoc. Prof.

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

• Erdoğan ÇETİNKAYA, Prof. Dr.

  Saglik Bilimleri Universitesi

  STUDY DIRECTOR

• Zeynep Betül ÖZCAN, M. Sc.

  Saglik Bilimleri Universitesi

  STUDY CHAIR

• Fulya Senem KARAAHMETOĞLU, M. Sc.

  Saglik Bilimleri Universitesi

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: May 11, 2023
• Study Start: February 13, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-02

Locations

TU (1)