Brain and Peripheral Muscle Oxygenation in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in cerebral oxygenation during exercise
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
COPD
干预措施: Aerobic Exercise (Treadmill Walking) (Other)
COPD
干预措施: Resistance Exercise (Upper and Lower Limb Strength Training) (Other)
COPD
干预措施: Breathing Exercises (Other)
COPD
干预措施: Cognitive Task (Stroop Task) (Other)
Healthy Individuals
干预措施: Aerobic Exercise (Treadmill Walking) (Other)
Healthy Individuals
干预措施: Resistance Exercise (Upper and Lower Limb Strength Training) (Other)
Healthy Individuals
干预措施: Breathing Exercises (Other)
Healthy Individuals
干预措施: Cognitive Task (Stroop Task) (Other)
结局指标
主要结局
Change in cerebral oxygenation during exercise
时间窗: Day 1
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.
次要结局
- 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)
研究者
ESRA PEHLIVAN
Principal Investigator
Saglik Bilimleri Universitesi