Health TrialsbyHealthPanel

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

ConditionCopd
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorSaglik Bilimleri Universitesi

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aerobic Exercise (Treadmill Walking)

    Other intervention

    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 intervention

    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

    Other intervention

    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 intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: COPDExperimental treatment 4 interventions
Group B: Healthy IndividualsExperimental treatment 4 interventions

Trial outcomes

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.

Time frame
Day 1

Secondary outcomes

1

Change in peripheral muscle oxygenation

NIRS device (Moxy, Fortiori Design LLC, Minnesota, USA). Parameters analyzed include minimum, maximum, and mean SmO₂ and tHb.

Time frame
Day 1
2

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.

Time frame
Pre-exercise (baseline) and immediately post-exercise (within 5 minutes after final exercise).
3

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.

Time frame
Baseline
4

Perceived Dyspnea (Modified Borg Scale)

Participant-reported dyspnea level evaluated before and after each exercise modality using the Modified Borg Scale (0-10).

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Saglik Bilimleri Universitesi

Lead sponsor

Source ClinicalTrials.gov
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