Effects of Aerobic Training on Cerebrovascular Function, Cognitive Performance and Gait Parameters in Patients With Parkinson's Disease: A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Raphael Mendes Ritti Dias
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Cerebrovascular Reactivity
概览
简要总结
This randomized controlled trial will investigate the effects of a 12-week supervised aerobic training program on cerebrovascular function, peripheral vascular health, cardiovascular autonomic modulation, cognition, non-motor symptoms, sleep, mood, gait biomechanics, quality of life, and body composition in patients with Parkinson's disease (Hoehn & Yahr stages 1-3). Participants will be randomly allocated to aerobic training or usual care.
详细描述
This is a parallel-group randomized controlled trial Participants (n=40) diagnosed with Parkinson's disease, stages 1-3 on Hoehn & Yahr scale, will be randomly allocated (1:1 block randomization) to:
- Aerobic Training Group;
- Control Group (usual care)
The intervention will last 12 weeks, 3 sessions/week Pre and post-intervention assessments will include:
- Cerebrovascular function: neurovascular coupling, cerebrovascular reactivity (breath-holding index), dynamic cerebral autoregulation (transfer function analysis), and acute cerebral blood flow response to exercise (transcranial Doppler; vertebral artery flow during silent reading).
- Peripheral vascular and cardiovascular function: brachial artery flow-mediated dilation, carotid intima-media thickness, resting blood pressure, resting heart rate, cardiorespiratory fitness (VO₂peak), heart rate variability (time and frequency domains), and baroreflex sensitivity.
- Cognitive performance: Montreal Cognitive Assessment (MoCA), Trail Making Test A and B, and Stroop Color-Word Test.
- Gait biomechanics: spatiotemporal parameters, 3D kinematics (Vicon system), and kinetics (force platform).
- Clinical and non-motor symptoms: UPDRS, Non-Motor Symptoms Scale (NMSS), sleep quality (PDSS), anxiety (PAS), depressive symptoms (GDS-15), apathy (Apathy Inventory), fatigue (Parkinson Fatigue Scale), pain (Numeric Rating Scale), and quality of life (PDQ-8).
- Body composition: quadriceps muscle thickness and subcutaneous adipose tissue thickness assessed by ultrasound.
All experimental sessions will be performed in the "on" medication state
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor will be blinded for the group of the subjects
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Parkinson's disease
- •Hoehn \& Yahr stages 1-3
- •Stable antiparkinsonian medication for at least 4 weeks
- •Montreal Cognitive Assessment (MoCA) score ≥ 18
- •Ability to walk independently (with or without assistive device)
- •Medical clearance for participation in moderate-intensity exercise
排除标准
- •Change in medication
- •Contraindication to exercise
研究组 & 干预措施
Usual Care
Participants will maintain their usual clinical care and daily activities without structured exercise intervention.
干预措施: Usual Care (Behavioral)
Aerobic Training
Participants will perform supervised aerobic training on a cycle ergometer, 3 times per week for 12 weeks, 40 minutes per session, at perceived exertion 12-13 on Borg scale.
干预措施: Aerobic training (Behavioral)
结局指标
主要结局
Change in Cerebrovascular Reactivity
时间窗: Baseline and 12 weeks
Breath-holding index (dimensionless) assessed by transcranial Doppler
Change in Neurovascular Coupling at 12 Weeks.
时间窗: Baseline and 12 weeks
Measured by relative (%) changes in middle cerebral artery blood flow velocity during standardized cognitive tasks (Stroop Color-Word Test, Trail Making Test A and B, and silent reading protocol) using transcranial Doppler ultrasound.
Change in Dynamic Cerebral Autoregulation
时间窗: Baseline and 12 weeks
Transfer function gain and phase (0.02-0.4 Hz frequency bands).
Change in Acute Cerebral Blood Flow Response to Exercise
时间窗: Baseline and 12 weeks
Change in middle cerebral artery velocity during 6-minute aerobic bout.
次要结局
- Change in Carotid Intima-Media Thickness(Baseline and 12 weeks)
- Change in Brachial Artery Endothelial Function(Baseline and 12 weeks)
- Change in Brachial Artery Baseline Diameter(Baseline and 12 weeks)
- Change in Resting Blood Pressure(Baseline and 12 weeks)
- Change in Resting Heart Rate(Baseline and 12 weeks)
- Change in SDNN(Baseline and 12 weeks)
- Change in Low Frequency Power(Baseline and 12 weeks)
- Change in Cognitive Function(Baseline and 12 weeks)
- Change in Executive Function and Attention(Baseline and 12 weeks)
- Change in Non-Motor Symptoms(Baseline and 12 weeks)
- Change in Parkinson Disease Severity(Baseline and 12 weeks)
- Change in Anxiety Severity(Baseline and 12 weeks)
- Change in Depressive Symptoms(Baseline and 12 weeks)
- Change in Apathy(Baseline and 12 weeks)
- Change in Fatigue(Baseline and 12 weeks)
- Change in Sleep Quality(Baseline and 12 weeks)
- Change in Pain(Baseline and 12 weeks)
- Change in Quality of Life(Baseline and 12 weeks)
- Change in Gait Speed(Baseline and 12 weeks)
- Change in Gait Kinematics(Baseline and 12 weeks)
- Change in Joint Moments During Walking(Baseline and 12 weeks)
- Change in Muscle Thickness(Baseline and 12 weeks)
- Change in Subcutaneous Adipose Tissue Thickness(Baseline and 12 weeks)
- Change in RMMSD(Baseline and 12 weeks)
- Change in High Frequency Power(Baseline and 12 weeks)
- Change in Low Frequency/High Frequency ratio(Baseline and 12 weeks)
- Change in Cadence(Baseline and 12 weeks)
- Change in Stride Length(Baseline and 12 weeks)
- Change in Double Support Time(Baseline and 12 weeks)
- Change in Joint Powers During Walking(Baseline and 12 weeks)
研究者
Raphael Mendes Ritti Dias
Professor
University of Nove de Julho