Muscle Oxygenation in Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05808621
• Other study ID #: 2023-19
• Status: Recruiting
• Start date: March 8, 2023
• Est. completion date: August 23, 2023

Study information

• Verified date: April 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: August 23, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Chronic Obstructive Pulmonary Disease Exacerbation
• Disease Progression
• Lung Diseases
• Lung Diseases, Obstructive
• Muscle Oxygenation
• Pulmonary Disease, Chronic Obstructive

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 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	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
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.	4 weeks
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.	4 weeks
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.	4 weeks