COPD (Chronic Obstructive Pulmonary Disease)NCT07801547
Muscle Oxygenation in Patients With COPD Exacerbation
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Acute Exacerbation Chronic Obstructive Pulmonary Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Acute Exacerbation Chronic Obstructive Pulmonary Disease, Muscle Oxygenation
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2026to 5 Feb 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alper kemal Gurbuz, PT, MSc. contact
Turkey (Türkiye)1 site
Hacettepe University
Ankara
Aynur Demirel, PT, PhD, Assoc. Prof., +905545295057, aynur.demirel@hacettepe.edu.tr
Alper Kemal Gurbuz, PT, MSc.
About this study
Official title: Evaluation of Respiratory and Peripheral Muscle Oxygenation in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
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
Read the detailed description
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.
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), Acute Exacerbation Chronic Obstructive Pulmonary Disease, Muscle Oxygenation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute copd patients | acute exacerbation of COPD | |
| stable copd patients | clinically stable without any acute exacerbations for at least the past 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline (1 day)
Secondary outcomes (6)
functional capacity
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.
Measured: baseline (1 day)
Gait speed
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
Measured: baseline (1 day)
Peripheral Muscle Strength
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
Measured: baseline (1 day)
pulmonary functions
Spirometry will be performed according to ATS/ERS guidelines. Values will be recorded.
Measured: baseline (1 day)
Dyspnea and Fatigue Perception
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.
Measured: baseline (1 day)
Activities of Daily Living
Activities of daily living will be assessed using the London Chest Activity of Daily Living (LCADL) scale (score range 0-75).
Measured: baseline (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start30 Aug 2026 (estimated)
- Primary completion5 Oct 2027 (estimated)
- Study completion5 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aynur Demirel, Hacettepe University
- Investigators
- Aynur Demirel, Study director, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801547
- Sponsor's protocol ID
- FTREK25/189
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Respiratory and Peripheral Muscle Oxygenation in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07801547
- Acronym / sponsor ID
- FTREK25/189
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease), Acute Exacerbation Chronic Obstructive Pulmonary Disease, Muscle Oxygenation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 5 Oct 2027 (estimated)
- Study completion
- 5 Feb 2028 (estimated)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute copd patients | – | –acute exacerbation of COPD |
| stable copd patients | – | –clinically stable without any acute exacerbations for at least the past 4 weeks. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
functional capacity
Time frame: baseline (1 day)
Gait speed
Time frame: baseline (1 day)
Peripheral Muscle Strength
Time frame: baseline (1 day)
pulmonary functions
Time frame: baseline (1 day)
Dyspnea and Fatigue Perception
Time frame: baseline (1 day)
Activities of Daily Living
Time frame: baseline (1 day)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alper kemal Gurbuz, PT, MSc. contact
Aynur Demirel study director
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Acute Exacerbation Chronic Obstructive Pulmonary Disease, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aynur Demirel, PT, PhD, Assoc. Prof. (+90 554 529 5057, aynur.demirel@hacettepe.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle Oxygen Saturation (time frame: baseline (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.