NCT06041126

Brief 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.

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 Apr 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

April 24, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

March 13, 2025

Status Verified

March 1, 2025

Enrollment Period

1.2 years

First QC Date

April 27, 2023

Last Update Submit

March 11, 2025

Conditions

Keywords

Chronic Obstructive Pulmonary DiseaseMuscle OxygenationDisease SeverityRespiratory Function

Outcome Measures

Primary Outcomes (1)

  • Muscle oxygenation

    The muscle oxygen monitor is a lightweight (42 g) and small (dimensions: 61 × 44 × 21

    one day

Secondary Outcomes (7)

  • Modified Medical Research Council Dyspnea Scale

    one day

  • COPD Assessment Test (CAT)

    one day

  • Charlson Comorbidity Index

    one day

  • Quadriceps muscle strength measurement

    one day

  • Six-minute walking test

    one day

  • +2 more secondary outcomes

Study Arms (2)

Group one

Patients with COPD according to the combined COPD assessment Global Intervention (GOLD) guidelines, participants who are in groups A and B (mild-moderate) will be included in group 1.

Group two

COPD patients according to the combined COPD assessment, according to the "Global Intervention (GOLD) guidelines", participants who are in groups C and D (severe-very severe) will be included in group 2.

Eligibility Criteria

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

Stable COPD Patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

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 ObstructiveRespiratory Aspiration

Condition Hierarchy (Ancestors)

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

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

April 27, 2023

First Posted

September 18, 2023

Study Start

April 24, 2023

Primary Completion

June 23, 2024

Study Completion

March 1, 2025

Last Updated

March 13, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations