Идёт набор NCT07285642

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

Без фазы С лечением Copd

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Aerobic Exercise (Treadmill Walking), Resistance Exercise (Upper and Lower Limb Strength Training), Breathing Exercises, Cognitive Task (Stroop Task).
Кому может быть актуально: Состояния в реестре: Copd. Базовые параметры: 40 лет — 70 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Turkey (Türkiye)
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

Другое 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).
Другое 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.
Другое 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.
Другое 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.

Первичные конечные точки

Change in cerebral oxygenation during exercise [Срок оценки: Day 1]

Вторичные конечные точки (5)

Change in peripheral muscle oxygenation [Срок оценки: Day 1]
Cognitive performance (reaction time, accuracy in Stroop task) [Срок оценки: Pre-exercise (baseline) and immediately post-exercise (within 5 minutes after final exercise).]
Six-Minute Walk Distance (6MWD) [Срок оценки: Baseline]
Perceived Dyspnea (Modified Borg Scale) [Срок оценки: Day 1]
Physical Activity Level (IPAQ-Short Form) [Срок оценки: Baseline]

Критерии участия

Критерии включения

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

Критерии исключения

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