Investigating the Effects of Aerobic Exercise With Blood Flow Restriction on Dual-task Postural Control and Anxiety Modulation in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 54
- 主要终点
- Change in Center of Pressure (CoP) Total Displacement
研究概览
简要总结
Reducing balance problems and anxiety severity are the top two research uncertainties for people with Parkinson's disease (PD). Besides having a mutually aggravating relationship between postural impairment and anxiety severity, dual tasking is a critical condition that would increase postural instability and anxiety level concurrently. High-intensity aerobic exercise could improve balance and reduce anxiety. However, the training benefits from high-intensity aerobic exercise are limited in people with PD due to disease-related symptoms. Blood flow restriction (BFR) has been applied to low-intensity exercise. By creating localized hypoxia and increasing metabolic stress, BFR could facilitate aerobic system and neural adaptations. However, for the PD population, only one study applied BFR to aerobic exercise with the research design of a single-case report, let alone investigating the effects of BFR aerobic exercise on postural control and anxiety level under a dual-task condition. With the measurements of behavioral performance, subjective anxiety questionnaire, skin conductance response, and electroencephalogram (EEG), the purpose of the 3-year research project is to investigate the effects of BFR aerobic exercise on dual-task postural performance, anxiety, and related brain activities in people with PD. In the first year, the investigators will investigate the immediate effect of one bout of BFR aerobic exercise on dual-task postural control and anxiety level. In the second and third years, the investigators will investigate the long-term training effects of BFR aerobic exercise on dual-task postural control, anxiety modulation, brain plasticity, and patient satisfaction. The present project is expected to have significant contributions to gaining a better insight into the neural correlates of balance and anxiety with BFR aerobic exercise, particularly under dual-task conditions, and provide an optimized rehabilitation strategy for people with PD in clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with idiopathic Parkinson's disease by a board-certified neurologist specializing in movement disorders.
- •Early-to-moderate stage of Parkinson's disease, corresponding to Hoehn and Yahr Stages 1 to 3 in the on-medication state.
- •Absence of other neurological or orthopedic conditions affecting balance and gait (e.g., stroke, vestibular disorders).
- •Mini-Mental State Examination (MMSE) score ≥ 26, indicating intact cognitive function without significant cognitive impairment.
排除标准
- •Contraindications to blood flow restriction (BFR), including a history of cardiopulmonary disease, pneumonia, varicose veins, diabetes mellitus, or intermittent claudication; uncontrolled/unstable hypertension; active smoking; or currently taking medications that increase the risk of blood clots.
- •Presence of depressive symptoms that could influence postural control or anxiety assessments, defined as currently taking antidepressant medications or scoring > 1 on item 1.3 (Depressed mood) of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I.
- •History of neurosurgical procedures, such as Deep Brain Stimulation (DBS).
- •Color vision deficiency or color blindness, which interferes with the visual color discrimination task.
研究组 & 干预措施
Aerobic Exercise with Blood Flow Restriction
Participants perform an aerobic exercise session combined with blood flow restriction
干预措施: Aerobic Exercise with Blood Flow Restriction (Behavioral)
Aerobic Exercise without Blood Flow Restriction
Participants perform the same aerobic exercise session without blood flow restriction
干预措施: Aerobic Exercise without Blood Flow Restriction (Behavioral)
结局指标
主要结局
Change in Center of Pressure (CoP) Total Displacement
时间窗: Assessed at baseline (pre-exercise) and immediately after the exercise session (post-exercise) in each of the two crossover visits (separated by 6-8 days).
Postural control will be evaluated by measuring total center of pressure (CoP) trajectory displacement during quiet standing (single-task condition) on a force platform. Total displacement represents the overall trajectory length of sway path. Values will be reported as the change from pre-exercise to post-exercise.
Change in Physiological Anxiety
时间窗: Assessed at baseline (pre-exercise) and immediately after the exercise session (post-exercise) in each of the two crossover visits (separated by 6-8 days).
Physiological anxiety: Mean skin conductance level (SCL) calculated from second 11 to 60 during task execution minus the resting baseline conductance level (measured in microsiemens, µS). Higher values indicate greater sympathetic activation and physiological anxiety.
Change in EEG Relative Band Power
时间窗: Assessed at baseline (pre-exercise) and immediately after the exercise session (post-exercise) in each of the two crossover visits (separated by 6-8 days).
Continuous electroencephalography (EEG) signals will be preprocessed and analyzed offline (including DC shift correction, blink artifact removal, and band-pass filtering at 1-50 Hz). Relative frequency band power will be computed using Fourier transform across regions of interest. Relative band power is calculated as the ratio of power within a specific frequency band to the total spectral power (1-50 Hz) and expressed as a percentage. Changes from pre-exercise to post-exercise will be assessed for both testing sessions.
次要结局
- Change in Cognitive Reaction Time During Dual-Task Standing(Assessed at baseline (pre-exercise) and immediately after the exercise session (post-exercise) in each of the two crossover visits (separated by 6-8 days).)
- Rating of Perceived Exertion (RPE)(Assessed during the exercise session (at the end of each 10-minute exercise bout and immediately post-exercise) in each of the two crossover visits.)
研究者
Cheng-Ya Huang
Professor
National Cheng Kung University