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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041126
• Other study ID #: 2023-72
• Status: Recruiting
• Start date: April 24, 2023
• Est. completion date: November 23, 2023

Study information

• Verified date: September 2023
• Source: Bandirma Onyedi Eylül University
• Contact: Gülhan Yilmaz Gökmen
• Phone: +90 266 606 4532
• Email: ggokmen[@]bandirma.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: November 23, 2023
• Est. primary completion date: September 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Disease Severity
• Lung Diseases
• Lung Diseases, Obstructive
• Muscle Oxygenation
• Pulmonary Disease, Chronic Obstructive
• Respiratory Function

Locations

Country	Name	City	State
Turkey	Bandirma Onyedi Eylül University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation	Balikesir

Sponsors (1)

Lead Sponsor	Collaborator
Bandirma Onyedi Eylül University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle oxygenation	The muscle oxygen monitor is a lightweight (42 g) and small (dimensions: 61 × 44 × 21	one day
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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