CopdNCT07285642
Brain and Peripheral Muscle Oxygenation in Patients With Chronic Obstructive Pulmonary Disease
A study testing Aerobic Exercise (Treadmill Walking), Resistance Exercise (Upper and Lower Limb Strength Training) and Breathing Exercises in people with Copd, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This interventional study aims to investigate the acute effects of different types of exercise on cerebral and peripheral muscle oxygenation in patients with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Copd
- What is being tested?
- Aerobic Exercise (Treadmill Walking), Resistance Exercise (Upper and Lower Limb Strength Training) and Breathing Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Apr 2025to 1 Nov 2026
- Phase
- Interventional
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 40-70 years
- Diagnosis of moderate-to-severe COPD (GOLD stage II-III)
- Stable disease (no exacerbation in previous 4 weeks)
- BMI 18.5-24.9 kg/m²
- Manual muscle strength ≥ 4 (MRC scale)
- Ability to perform exercise tests safely
- Written informed consent
Who cannot join
- Severe comorbid conditions (uncontrolled cardiac, neurological, or orthopedic disease)
- Need for high-flow oxygen therapy (>2 L/min)
- History of cerebrovascular disease or transient ischemic attack
- Musculoskeletal or dermatological conditions impairing NIRS measurement sites
- Restrictive lung disease, interstitial lung disease, or small-airway disease
- Participation in an exercise program within the last 12 months
Show all 12Show fewer
- Healthy Controls
- Age 40-70 years
- No acute or chronic disease
- Non-smoker
- BMI 18.5-24.9 kg/m²
- No musculoskeletal limitations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Esra Pehlivan
Istanbul, 34668
Esra Pehlivan, +90 216 777 8 777, esra.pehlivan@sbu.edu.tr
About this study
This interventional study aims to investigate the acute effects of different types of exercise on cerebral and peripheral muscle oxygenation in patients with chronic obstructive pulmonary disease (COPD). Functional near-infrared spectroscopy (fNIRS) and near-infrared spectroscopy (NIRS) will be used simultaneously to measure oxygenation changes in the prefrontal cortex and the vastus lateralis muscle during rest, Stroop task performance, the six-minute walk test, aerobic, strengthening, and breathing exercises.
The study will compare COPD patients and age- and sex-matched healthy controls to determine how brain and muscle oxygenation responses differ between groups and among exercise modalities. The findings are expected to guide the design of safe, individualized pulmonary rehabilitation programs that optimize oxygenation without compromising safety.
Read the detailed description
Functional near-infrared spectroscopy (fNIRS) and near-infrared spectroscopy (NIRS) allow real-time, non-invasive assessment of tissue oxygenation. Although widely used in neurology and exercise physiology, their application in pulmonary diseases such as COPD remains limited.
This study is designed as a non-randomized controlled, multidisciplinary trial conducted at Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul. The research team includes specialists in physiotherapy and rehabilitation, pulmonology, and neuroscience.
Participants will undergo a single standardized pulmonary rehabilitation (PR) session comprising three exercise modalities:Aerobic training, Peripheral strengthening exercises and Breathing exercises.
Before and after exercise, participants will perform the Stroop cognitive task to evaluate executive function and its relationship with cerebral oxygenation. Continuous fNIRS and NIRS monitoring will occur at rest, during each exercise, and during recovery.
- Conditions
- Copd
- Being tested
- Aerobic Exercise (Treadmill Walking), Resistance Exercise (Upper and Lower Limb Strength Training), Breathing Exercises, Cognitive Task (Stroop Task)
- Keywords
- COPD, FNIRS, Brain, Quadriceps femoris
- 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.
Aerobic Exercise (Treadmill Walking)Other
Participants perform treadmill walking for 15 minutes at 60% of the heart rate reserve (HRR), following a 2-minute warm-up period. Exercise intensity is calculated individually using the Karvonen formula. Continuous oxygenation monitoring is conducted via fNIRS (prefrontal cortex) and NIRS (vastus lateralis).
Resistance Exercise (Upper and Lower Limb Strength Training)Other
Participants perform resistance exercises for upper and lower limb major muscle groups using 60% of one-repetition maximum (1RM). Each exercise consists of 12 repetitions per set, repeated for 15 minutes with 10-second rest intervals between sets. Movements include shoulder flexion/abduction/extension, hip flexion/abduction/adduction/extension, knee extension, and squatting.
Breathing ExercisesOther
Participants perform controlled breathing exercises including diaphragmatic, chest, and lateral basal breathing techniques. Each pattern is executed in 10-repetition cycles, repeated for 15 minutes with 10-second rest intervals. All sessions begin with pursed-lip breathing instruction and are performed in a seated position.
Cognitive Task (Stroop Task)Other
A computerized color-word interference test (PsychoPy software) is administered before and after the exercise session to evaluate executive function and attention. Performance is analyzed in relation to concurrent fNIRS measurements from the prefrontal cortex.
| Study group | Role | What they receive |
|---|---|---|
| COPD | Experimental | Not described Receives: Other: Aerobic Exercise (Treadmill Walking); Other: Resistance Exercise (Upper and Lower Limb Strength Training); Other: Breathing Exercises; Other: Cognitive Task (Stroop Task) |
| Healthy Individuals | Experimental | Not described Receives: Other: Aerobic Exercise (Treadmill Walking); Other: Resistance Exercise (Upper and Lower Limb Strength Training); Other: Breathing Exercises; Other: Cognitive Task (Stroop Task) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cerebral oxygenation during exercise
fNIRS device (Artinis Brite Lite, The Netherlands) with 8-channel prefrontal montage, sampling at 10 Hz. Data analyzed with MATLAB-based Homer3 and NIRS-KIT software.
Measured: Day 1
Secondary outcomes (5)
Change in peripheral muscle oxygenation
NIRS device (Moxy, Fortiori Design LLC, Minnesota, USA). Parameters analyzed include minimum, maximum, and mean SmO₂ and tHb.
Measured: Day 1
Cognitive performance (reaction time, accuracy in Stroop task)
Cognitive performance measured as reaction time (ms) and accuracy (%) during a computerized Stroop task performed before and after the exercise session. This reflects acute changes in executive function and attention related to cerebral oxygenation.
Measured: Pre-exercise (baseline) and immediately post-exercise (within 5 minutes after final exercise).
Six-Minute Walk Distance (6MWD)
Functional exercise capacity assessed using the standardized 6-minute walk test according to American Thoracic Society (ATS) guidelines. Distance covered is recorded in meters. Test repeated twice to minimize learning effect, and the better result is used for analysis.
Measured: Baseline
Perceived Dyspnea (Modified Borg Scale)
Participant-reported dyspnea level evaluated before and after each exercise modality using the Modified Borg Scale (0-10).
Measured: Day 1
Physical Activity Level (IPAQ-Short Form)
Self-reported physical activity level evaluated using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). Results expressed in MET-min/week.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start30 Apr 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ESRA PEHLIVAN, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285642
- Sponsor's protocol ID
- fNIRS&Exercise
- Status last verified
- Apr 2026
- First submitted
- 20 Nov 2025
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain and Peripheral Muscle Oxygenation in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07285642
- Acronym / sponsor ID
- fNIRS&Exercise
- Conditions
- Copd
- Keywords
- COPD, FNIRS, Brain, Quadriceps femoris
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 16 Dec 2025 (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.
This interventional study aims to investigate the acute effects of different types of exercise on cerebral and peripheral muscle oxygenation in patients with chronic obstructive pulmonary disease (COPD). Functional near-infrared spectroscopy (fNIRS) and near-infrared spectroscopy (NIRS) will be used simultaneously to measure oxygenation changes in the prefrontal cortex and the vastus lateralis muscle during rest, Stroop task performance, the six-minute walk test, aerobic, strengthening, and breathing exercises.
The study will compare COPD patients and age- and sex-matched healthy controls to determine how brain and muscle oxygenation responses differ between groups and among exercise modalities. The findings are expected to guide the design of safe, individualized pulmonary rehabilitation programs that optimize oxygenation without compromising safety.
Detailed description
Functional near-infrared spectroscopy (fNIRS) and near-infrared spectroscopy (NIRS) allow real-time, non-invasive assessment of tissue oxygenation. Although widely used in neurology and exercise physiology, their application in pulmonary diseases such as COPD remains limited.
This study is designed as a non-randomized controlled, multidisciplinary trial conducted at Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul. The research team includes specialists in physiotherapy and rehabilitation, pulmonology, and neuroscience.
Participants will undergo a single standardized pulmonary rehabilitation (PR) session comprising three exercise modalities:Aerobic training, Peripheral strengthening exercises and Breathing exercises.
Before and after exercise, participants will perform the Stroop cognitive task to evaluate executive function and its relationship with cerebral oxygenation. Continuous fNIRS and NIRS monitoring will occur at rest, during each exercise, and during recovery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD | Experimental | Other: Aerobic Exercise (Treadmill Walking), Other: Resistance Exercise (Upper and Lower Limb Strength Training), Other: Breathing Exercises, Other: Cognitive Task (Stroop Task) |
| Healthy Individuals | Experimental | Other: Aerobic Exercise (Treadmill Walking), Other: Resistance Exercise (Upper and Lower Limb Strength Training), Other: Breathing Exercises, Other: Cognitive Task (Stroop Task) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 40-70 years
- Diagnosis of moderate-to-severe COPD (GOLD stage II-III)
- Stable disease (no exacerbation in previous 4 weeks)
- BMI 18.5-24.9 kg/m²
- Manual muscle strength ≥ 4 (MRC scale)
Key exclusion criteria (12 listed)
- Severe comorbid conditions (uncontrolled cardiac, neurological, or orthopedic disease)
- Need for high-flow oxygen therapy (>2 L/min)
- History of cerebrovascular disease or transient ischemic attack
- Musculoskeletal or dermatological conditions impairing NIRS measurement sites
- Restrictive lung disease, interstitial lung disease, or small-airway disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic Exercise (Treadmill Walking)Participants perform treadmill walking for 15 minutes at 60% of the heart rate reserve (HRR), following a 2-minute warm-up period. Exercise intensity is calculated individually using the Karvonen formula. Continuous oxygenation monitoring is conducted via fNIRS (prefrontal cortex) and NIRS (vastus lateralis). | Other | COPD, Healthy Individuals |
| Resistance Exercise (Upper and Lower Limb Strength Training)Participants perform resistance exercises for upper and lower limb major muscle groups using 60% of one-repetition maximum (1RM). Each exercise consists of 12 repetitions per set, repeated for 15 minutes with 10-second rest intervals between sets. Movements include shoulder flexion/abduction/extension, hip flexion/abduction/adduction/extension, knee extension, and squatting. | Other | COPD, Healthy Individuals |
| Breathing ExercisesParticipants perform controlled breathing exercises including diaphragmatic, chest, and lateral basal breathing techniques. Each pattern is executed in 10-repetition cycles, repeated for 15 minutes with 10-second rest intervals. All sessions begin with pursed-lip breathing instruction and are performed in a seated position. | Other | COPD, Healthy Individuals |
| Cognitive Task (Stroop Task)A computerized color-word interference test (PsychoPy software) is administered before and after the exercise session to evaluate executive function and attention. Performance is analyzed in relation to concurrent fNIRS measurements from the prefrontal cortex. | Other | COPD, Healthy Individuals |
Primary outcome
Change in cerebral oxygenation during exercise
Time frame: Day 1
fNIRS device (Artinis Brite Lite, The Netherlands) with 8-channel prefrontal montage, sampling at 10 Hz. Data analyzed with MATLAB-based Homer3 and NIRS-KIT software.
5 secondary outcomes
Change in peripheral muscle oxygenation
Time frame: Day 1
Cognitive performance (reaction time, accuracy in Stroop task)
Time frame: Pre-exercise (baseline) and immediately post-exercise (within 5 minutes after final exercise).
Six-Minute Walk Distance (6MWD)
Time frame: Baseline
Perceived Dyspnea (Modified Borg Scale)
Time frame: Day 1
Physical Activity Level (IPAQ-Short Form)
Time frame: Baseline
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 15 Apr 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise (Treadmill Walking), Resistance Exercise (Upper and Lower Limb Strength Training) and Breathing Exercises in people with Copd, run by Saglik Bilimleri Universitesi 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 7 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 15 Apr 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 Esra Pehlivan (+90216 777 87 77, esra.pehlivan@sbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cerebral oxygenation during exercise (time frame: Day 1). 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 15 Apr 2026.