Muscle Oxygenation in Chronic Obstructive Pulmonary Disease

Investigation of Peripheral Muscle Oxygenation At Rest and Movement in Hospitalized Patients in Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease and Comparison with Stable Period

The aim of our study is to examine the Peripheral Muscle Oxygenations at rest and in motion on the 2nd day of hospitalized patients and before discharge in Severe Acute Exacerbation of Chronic Obstructive Pulmonary Disease and to compare the results in the hospital periods by repeating the tests in the stable periods of the patients 1 month after discharge.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Chronic Obstructive Pulmonary Disease Exacerbation; 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: No

• Sampling Method: Probability Sample

Study Population

COPD hospitalized with Severe Acute Exacerbation

Description

Inclusion Criteria:

• Being a COPD patient hospitalized with Severe Acute Exacerbation
• be between 40-80 years old
• Having a Body Mass Index below 35

Exclusion Criteria:

• Patients who do not want to participate in the study
• Patients requiring intensive care follow-up during their hospitalization Arthritis, neurological disease, deep vein thrombosis, peripheral arterial disease, muscle weakness, broken etc. patients with the condition
• Extensive parenchyma such as malignancy, pulmonary embolism, vasculitis, collagen tissue diseases, interstitial fibrosis, severe pneumonia patients with damage
• Patients with severe dyspnea and hemodynamic instability who cannot perform the sit-up test

Study Plan

How is the study designed?

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 mm) device that measures regional blood flow and oxygenation by placing it on the skin non-invasively with near infrared spectroscopy (NIRS). The device, which has data collection and telemetric features, also allows O 2 measurement in non-laboratory environments and field-based research.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1 minute sit and stand test	The test aims to assess your exercise capacity and leg muscle strength. The movement required is to get up from this chair with the legs straight and sit back continuing the repetitions as fast as possible within one minute. The 1-minute STS test was performed with a chair of standard height of 46 cm without armrests. The patient was ensured to be seated upright on the chair positioned against a wall. The patient sat with the knees and hips flexed to 90°, feet placed flat on the floor hip-width apart, and the hands placed on the hips. Every get up from one's chair was validated to check if a complete sit-to-stand-to-sit sequence was achieved.	4 weeks
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.	4 weeks
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.	4 weeks
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.	4 weeks

Collaborators and Investigators

• Sponsor: Bandırma Onyedi Eylül University

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2023
• Primary Completion (Actual): June 23, 2024
• Study Completion (Actual): March 10, 2025

Study Registration Dates

• First Submitted: March 13, 2023
• First Submitted That Met QC Criteria: April 10, 2023
• First Posted (Actual): April 11, 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; Chronic Obstructive Pulmonary Disease Exacerbation
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Disease Progression
• Other Study ID Numbers: 2023-19

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