Brain and Peripheral Muscle Oxygenation in Patients With Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 30, 2025
CompletedFirst Submitted
Initial submission to the registry
November 20, 2025
CompletedFirst Posted
Study publicly available on registry
December 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
April 15, 2026
April 1, 2026
1.5 years
November 20, 2025
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Day 1
Secondary Outcomes (5)
Change in peripheral muscle oxygenation
Day 1
Cognitive performance (reaction time, accuracy in Stroop task)
Pre-exercise (baseline) and immediately post-exercise (within 5 minutes after final exercise).
Six-Minute Walk Distance (6MWD)
Baseline
Perceived Dyspnea (Modified Borg Scale)
Day 1
Physical Activity Level (IPAQ-Short Form)
Baseline
Study Arms (2)
COPD
EXPERIMENTALHealthy Individuals
EXPERIMENTALInterventions
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.
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.
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.
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Esra Pehlivan
Istanbul, 34668, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 20, 2025
First Posted
December 16, 2025
Study Start
April 30, 2025
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
April 15, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share