The Effect of Clinical Parameters on Muscle Oxygenation in Patients with COPD

The Effect of Disease Severity and Respiratory Functions on Muscle Oxygenation in Stable COPD Patients

The aim of this study is to examine the peripheral muscle oxygenation of patients with Chronic Obstructive Pulmonary Disease at rest, during submaximal exercise and recovery, and to examine the effects of disease severity and respiratory functions on peripheral muscle oxygenations. In this study, the effect of disease severity and respiratory problems on peripheral muscle metabolism of patients with COPD will be explained.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Disease Severity; Respiratory Function; Muscle Oxygenation

• Study Type: Observational
• Enrollment (Actual): 41

Contacts and Locations

Study Locations

• Turkey
  • Balıkesir, Turkey
    • Bandırma Onyedi Eylül University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Stable COPD Patients

Description

Inclusion Criteria:

• Being diagnosed with COPD (according to GOLD Staging: GOLD 1, GOLD 2, GOLD 3, GOLD 4)
• Being between the ages of 40-80
• Body Mass Index <35
• Not having an acute exacerbation in the last 3 months

Exclusion Criteria:

• Patients who do not want to participate in the study
• Arthritis causing weakness in the lower extremity, neurological disease, deep vein thrombosis, peripheral arterial disease, muscle weakness, fracture etc. patients with the condition
• Common diseases such as malignancy, pulmonary embolism, vasculitis, collagen tissue diseases, interstitial fibrosis, severe pneumonia patients with parenchymal destruction
• Patients with severe dyspnea and hemodynamic instability who cannot perform the 6 Minute Walk Test

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group one; Patients with COPD according to the combined COPD assessment Global Intervention (GOLD) guidelines, participants who are in groups A and B (mild-moderate) will be included in group 1.
Group two; COPD patients according to the combined COPD assessment, according to the "Global Intervention (GOLD) guidelines", participants who are in groups C and D (severe-very severe) will be included in group 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle oxygenation	The muscle oxygen monitor is a lightweight (42 g) and small (dimensions: 61 × 44 × 21	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Medical Research Council Dyspnea Scale	Medical Research Council (MRC) Dyspnea Scale will be used to assess the severity of dyspnea. The severity of dyspnea during activities of daily living is graded from 0 to 4 on the Medical Research Council (MRC) Dyspnea Scale.	one day
COPD Assessment Test (CAT)	The COPD Assessment Test (CAT) is a new scoring system for COPD patients, which provides a simple method for assessing the impact of COPD on the patient's health. Range of CAT scores from 0-40.	one day
Charlson Comorbidity Index	The Charlson Comorbidity Index was first developed in 1987 by Mary Charlson and colleagues as a weighted index to predict risk of death within 1 year of hospitalization for patients with specific comorbid conditions. Nineteen conditions were included in the index. The total score in the CCI is derived by summing the assigned weights of all comorbid conditions presented by the client. Higher scores indicate a more severe condition and consequently, a worse prognosis.	one day
Quadriceps muscle strength measurement	Quadriceps muscle strength measurement of the patients will be evaluated with a manual muscle strength measuring device (Lafayette Instrument, USA) and recorded in kg/force. In muscle strength measurements, maximal voluntary isometric contraction (make test), which is reported to be more reliable in the literature and is frequently used, will be used. It will be repeated three times in both lower extremities with an interval of 30 seconds and the highest measurement will be recorded. For quadriceps muscle strength measurement, the patients will be seated on the treatment table with their legs hanging down and the thigh will be fixed by placing a rolled towel under the knee joint of the side to be evaluated. In this position, the patient will be asked to extend until the knee is locked, and the resistance will be given just above the ankle joint.	one day
Six-minute walking test	It is a submaximal exercise capacity measurement test. The patient is asked to walk as briskly as possible on a flat surface of 30 meters for 6 minutes. In our study, the test will be carried out in a 30-meter corridor in accordance with the guidelines.	one day
Pulmonary Function Test	Pulmonary function will be evaluated with the spirometry. Dynamic lung volume measurements will be made according to American Thoracic Society and European Respiratory Society criteria.	one day
Maximum Inspiratory Pressure / Maximum Expiratory Pressure Measurement	Respiratory muscle strength of individuals will be measured using an electronic and portable oral pressure measurement device, according to ATS / ERS criteria, with COSMED brand Pony FX model portable spirometer (COSMED, Italy). It is one of the most commonly used and noninvasive methods for the evaluation of respiratory muscle strength. With this method, maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) are measured. MIP and MEP are intraoral pressures measured during maximal breathing against a valve that closes the airway during maximal inspiration and expiration.	one day

Collaborators and Investigators

• Sponsor: Bandırma Onyedi Eylül University

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2023
• Primary Completion (Actual): June 23, 2024
• Study Completion (Actual): March 1, 2025

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: September 14, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; Muscle Oxygenation; Respiratory Function; Disease Severity
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2023-72

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No