Muscle Oxygenation in Chronic Obstructive Pulmonary Disease

Sponsor
Bandırma Onyedi Eylül University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05808621
Collaborator
(none)
34
1
5.5
6.2

Study Details

Study Description

Brief 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
34 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
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
Actual Study Start Date :
Mar 8, 2023
Anticipated Primary Completion Date :
Jun 23, 2023
Anticipated Study Completion Date :
Aug 23, 2023

Outcome Measures

Primary Outcome Measures

  1. Muscle oxygenation [4 weeks]

    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.

Secondary Outcome Measures

  1. 1 minute sit and stand test [4 weeks]

    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.

  2. Modified Medical Research Council Dyspnea Scale: [4 weeks]

    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.

  3. COPD Assessment Test (CAT) [4 weeks]

    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. Charlson Comorbidity Index [4 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bandırma Onyedi Eylül University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Balıkesir Turkey

Sponsors and Collaborators

  • Bandırma Onyedi Eylül University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gulhan Yilmaz Gokmen, Assistant Professor, Bandırma Onyedi Eylül University
ClinicalTrials.gov Identifier:
NCT05808621
Other Study ID Numbers:
  • 2023-19
First Posted:
Apr 11, 2023
Last Update Posted:
Apr 11, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gulhan Yilmaz Gokmen, Assistant Professor, Bandırma Onyedi Eylül University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 11, 2023