NCT05808621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2023

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 13, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

1.3 years

First QC Date

March 13, 2023

Last Update Submit

March 11, 2025

Conditions

Keywords

Chronic Obstructive Pulmonary DiseaseMuscle OxygenationChronic Obstructive Pulmonary Disease Exacerbation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 1 minute sit and stand test

    4 weeks

  • Modified Medical Research Council Dyspnea Scale:

    4 weeks

  • COPD Assessment Test (CAT)

    4 weeks

  • Charlson Comorbidity Index

    4 weeks

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

COPD hospitalized with Severe Acute Exacerbation

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Balıkesir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 13, 2023

First Posted

April 11, 2023

Study Start

March 8, 2023

Primary Completion

June 23, 2024

Study Completion

March 10, 2025

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations