Muscle Oxygenation in Patients With COPD Exacerbation

NCT07801547 | Not Yet Recruiting

• 1 other identifier: FTREK25/189
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic obstructive pulmonary disease (COPD) is often complicated by acute exacerbations, which lead to functional impairments, increased dyspnea, and a rapid decline in lung function. During an exacerbation, impaired pulmonary gas exchange, systemic inflammation, and increased work of breathing significantly alter oxygen availability and metabolic demand in skeletal muscles. The aim of this study is to evaluate and compare respiratory and peripheral muscle oxygenation in patients with acute exacerbation of COPD (AECOPD) and patients with clinically stable COPD. By examining these physiological changes, the study seeks to determine the impact of exacerbations on muscle function and oxygenation efficiency

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Acute Exacerbation Chronic Obstructive Pulmonary Disease; Muscle Oxygenation

Outcome Measures

Primary Outcomes (1)

• Muscle Oxygen Saturation

  Muscle oxygen saturation (SmO\_2) will be measured continuously using Near-Infrared Spectroscopy (NIRS) (Train.Red FYER) on the intercostal, deltoid, and dominant quadriceps muscles. The primary parameter ΔSmO\_2 max represents the difference between the peak SmO\_2 during functional tasks (30-second sit-to-stand test, 4-meter gait speed test, and upper extremity assessment) and the baseline resting

  baseline (1 day)

Secondary Outcomes (6)

• functional capacity

  baseline (1 day)

• Gait speed

  baseline (1 day)

• Peripheral Muscle Strength

  baseline (1 day)

• pulmonary functions

  baseline (1 day)

• Dyspnea and Fatigue Perception

  baseline (1 day)

Study Arms (2)

Acute copd patients

acute exacerbation of COPD

stable copd patients

clinically stable without any acute exacerbations for at least the past 4 weeks.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients aged 40 years and older diagnosed with Chronic Obstructive Pulmonary Disease (COPD) according to GOLD guidelines. The sample includes two distinct cohorts: patients admitted or presenting with an acute exacerbation of COPD (AECOPD), and patients in a clinically stable period (GOLD Grades 1-4) without exacerbations in the preceding 4 weeks.

You may qualify if:

• Acute Exacerbation Group: 1. Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) 2. Hospital admission or presentation due to an acute exacerbation of COPD 3. Age 40 years or older 4. Voluntary agreement to participate with signed written informed consent Clinically Stable Group: 1. Diagnosis of COPD (GOLD Stage 1, 2, 3, or 4) 2. Age 40 years or older 3. Clinically stable condition for at least the past 4 weeks without acute exacerbations 4. Voluntary agreement to participate with signed written informed consent

You may not qualify if:

• Clinically Stable Group: 1. History of lung cancer, sarcoidosis, tuberculosis, and/or prior lung surgery 2. Known mental or cognitive impairment.

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Aynur Demirel

  Hacettepe University

  STUDY DIRECTOR

Central Study Contacts

Aynur Demirel, PT, PhD, Assoc. Prof.

CONTACT

+90 554 529 5057; aynur.demirel@hacettepe.edu.tr

Alper kemal Gurbuz, PT, MSc.

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PhD, Assoc. Prof.

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 3, 2026
• Study Start: August 30, 2026
• Primary Completion (Estimated): October 5, 2027
• Study Completion (Estimated): February 5, 2028
• Last Updated: September 3, 2026

Record last verified: 2026-08

Locations

TU (1)