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NCT Number: NCT07801547

Muscle Oxygenation in Patients With COPD Exacerbation

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

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

Location contact

Alper Kemal Gurbuz, PT, MSc.

SUB_INVESTIGATOR

Aynur Demirel, PT, PhD, Assoc. Prof.

CONTACT

[email protected]

+905545295057

Aynur Demirel, PT, PhD, Assoc. Prof.

PRINCIPAL_INVESTIGATOR

Aysu Yalman, PT, MSc.

SUB_INVESTIGATOR

Gulse Ozer, PT

SUB_INVESTIGATOR

Hidaye Yamikan, PT, MSc.

SUB_INVESTIGATOR

Irem Suzen, PT, MSc.

SUB_INVESTIGATOR

Oguz Karcioglu, MD, Assoc Prof.

SUB_INVESTIGATOR

About this study

Chronic obstructive pulmonary disease (COPD) is characterized by recurrent acute exacerbations that negatively affect patients' quality of life and accelerate lung function decline. Severe exacerbations requiring hospitalization pose a significant mortality risk both during admission and in the following year.

During acute exacerbations, maximal pressure generation by respiratory muscles declines, and respiratory muscle efficiency-particularly of the diaphragm-is significantly reduced. Acute dynamic hyperinflation further shortens the inspiratory muscles, leading to functional muscle weakness. Consequently, accessory respiratory muscles are recruited maximally, often causing notable alterations in chest-wall and abdominal kinematics. Due to the requirement of spending a higher proportion of their maximum capacity with each breath, these patients face an elevated risk of developing respiratory muscle fatigue. Exacerbations lead to severe hypoxemia caused by impaired pulmonary gas exchange, driven primarily by ventilation-perfusion mismatch and increased tissue oxygen consumption. Acute hypoxemia exacerbates muscle weakness and impairs skeletal muscle function. Even after discharge from respiratory intensive care units following severe exacerbations, persistent respiratory muscle dysfunction is observed in more than a third of patients, requiring additional care and rehabilitation.

Physiological factors such as impaired gas exchange, reduced perfusion, and systemic inflammation during exacerbations substantially impact muscle oxygenation. Reduced arterial oxygen content diminishes oxygen availability to peripheral tissues and muscles. Simultaneously, the metabolic demands of both respiratory and peripheral muscles increase due to the heightened work of breathing and systemic stress.

This study aims to investigate respiratory and peripheral muscle oxygenation in patients with AECOPD and stable COPD, evaluating underlying physiological changes and assessing the impact of exacerbations on muscle function and oxygenation dynamics.

The aim of study is to investigate respiratory and peripheral muscle oxygenation in patients with AECOPD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Acute Exacerbation Group: 1. Active participation in a formal pulmonary rehabilitation program 2. Co-existing neurological disorders 3. Heart failure classified as New York Heart Association (NYHA) Class III or IV 4. Unstable mental or cognitive status (Mini-Mental State Examination [MMSE] score ≤24) 5. History of surgical intervention within the past three months 6. Presence of malignant conditions .

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

Treatment and study plan

Primary outcomes

  1. Muscle Oxygen Saturation

    Time frame: baseline (1 day)

    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

Secondary outcomes

  1. functional capacity

    Time frame: baseline (1 day)

    30-Second Sit-to-Stand Test: Assesses functional lower-limb muscle strength and exercise capacity. The total number of completed full stand-ups from a chair (height 43.2 cm) within 30 seconds will be recorded.

  2. Gait speed

    Time frame: baseline (1 day)

    4-Meter Gait Speed Test: Gait speed will be evaluated over a 4-meter course at normal walking pace. Gait speed is calculated in meters per second (m/s) by dividing 4 meters by the time taken

  3. Peripheral Muscle Strength

    Time frame: baseline (1 day)

    Maximal isometric handgrip strength will be measured in kilograms (kg) using a digital hand dynamometer (Baseline BIMS). The highest value of three trials for both dominant and non-dominant hands will be recorded

  4. pulmonary functions

    Time frame: baseline (1 day)

    Spirometry will be performed according to ATS/ERS guidelines. Values will be recorded.

  5. Dyspnea and Fatigue Perception

    Time frame: baseline (1 day)

    Dyspnea will be evaluated using the Modified Medical Research Council (mMRC) scale (grades 0-4) and Visual Analog Scale (VAS, 0-10 cm). Fatigue perception will be assessed using the Modified Borg Scale (0-10) before and after functional tests.

  6. Activities of Daily Living

    Time frame: baseline (1 day)

    Activities of daily living will be assessed using the London Chest Activity of Daily Living (LCADL) scale (score range 0-75).

Study contacts

Contact information is provided by the study sponsor or research team.

Alper kemal Gurbuz, PT, MSc.

CONTACT

Aynur Demirel, PT, PhD, Assoc. Prof.

CONTACT

[email protected]

+90 554 529 5057

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Evaluation of Respiratory and Peripheral Muscle Oxygenation in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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