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Brain and Peripheral Muscle Oxygenation in Patients With Chronic Obstructive Pulmonary Disease

Brain and Peripheral Muscle Oxygenation in Patients With Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07285642
Enrollment
60
Registered
2025-12-16
Start date
2025-04-30
Completion date
2026-11-01
Last updated
2026-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Copd

Keywords

COPD, FNIRS, Brain, Quadriceps femoris

Brief 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). 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.

Interventions

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).

OTHERResistance 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.

OTHERBreathing 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.

OTHERCognitive 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.

Sponsors

Saglik Bilimleri Universitesi
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* 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

Exclusion criteria

* 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 Healthy Controls * Age 40-70 years * No acute or chronic disease * Non-smoker * BMI 18.5-24.9 kg/m² * No musculoskeletal limitations

Design outcomes

Primary

MeasureTime frameDescription
Change in cerebral oxygenation during exerciseDay 1fNIRS 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.

Secondary

MeasureTime frameDescription
Change in peripheral muscle oxygenationDay 1NIRS device (Moxy, Fortiori Design LLC, Minnesota, USA). Parameters analyzed include minimum, maximum, and mean SmO₂ and tHb.
Cognitive performance (reaction time, accuracy in Stroop task)Pre-exercise (baseline) and immediately post-exercise (within 5 minutes after final exercise).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.
Six-Minute Walk Distance (6MWD)BaselineFunctional 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.
Perceived Dyspnea (Modified Borg Scale)Day 1Participant-reported dyspnea level evaluated before and after each exercise modality using the Modified Borg Scale (0-10).
Physical Activity Level (IPAQ-Short Form)BaselineSelf-reported physical activity level evaluated using the International Physical Activity Questionnaire - Short Form (IPAQ-SF). Results expressed in MET-min/week.

Countries

Turkey (Türkiye)

Contacts

CONTACTEsra Pehlivan
esra.pehlivan@sbu.edu.tr+90216 777 87 77

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 16, 2026