Brain and Peripheral Muscle Oxygenation in Patients With Chronic Obstructive Pulmonary Disease
NCT ID: NCT07285642
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
60 participants
INTERVENTIONAL
2025-12-30
2026-11-01
Brief Summary
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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
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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COPD
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).
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.
Breathing Exercises
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)
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.
Healthy Individuals
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).
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.
Breathing Exercises
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)
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.
Interventions
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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).
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.
Breathing Exercises
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)
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
Healthy Controls
* Age 40-70 years
* No acute or chronic disease
* Non-smoker
* BMI 18.5-24.9 kg/m²
* No musculoskeletal limitations
40 Years
70 Years
ALL
Yes
Sponsors
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Saglik Bilimleri Universitesi
OTHER
Responsible Party
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ESRA PEHLIVAN
Principal Investigator
Locations
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Esra Pehlivan
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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fNIRS&Exercise
Identifier Type: -
Identifier Source: org_study_id