Challenging Physical Exercise to Improve Balance: Effects of Multidomain Boxing-Based Training in People With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change from Baseline in Mini-Balance Evaluation Systems Test (MiniBESTest) Total Score
研究概览
简要总结
The goal of this clinical trial is to learn if physical exercise that extensively and simultaneously challenges the brain's balance control network is effective in improving balance for people with mild to moderate Parkinson's disease.
The study aims to test a specific hypothesis: that a physically demanding, "multidomain" program-which trains multiple areas of balance at the same time-will produce significantly better results than simple exercises that only partially address the balance network.
To test this, researchers will use a specialized boxing-based program (EBA-B) as a model of challenging exercise. This will be compared to an active control group performing simple, low-intensity mobility movements in a chair.
The main questions it aims to answer are:
- Does exercise that simultaneously challenges multiple domains of balance (using boxing as a tool) produce superior global improvements compared to less demanding programs?
- Is this extensive neural challenge more effective at reducing motor symptoms and improving functional mobility?
Participants will:
- Complete an 8-week "challenging" phase involving 50-minute group boxing sessions (EBA-B) 3 times per week, designed to challenge speed, agility, and coordination.
- Complete an 8-week "simple exercise" phase involving 20-minute home-based mobility seated workout 5 times per week, along with weekly education talks.
- Undergo clinical evaluations and balance tests at the start, middle, and end of the study to measure changes in their mobility
详细描述
Background and Rationale Balance control is a complex function managed by a distributed neural network within the central nervous system, where the basal ganglia serve as a central node operating in coordination with the cerebral cortex, brainstem, and cerebellum. This network spans multiple neurochemical systems, including dopaminergic, cholinergic, and serotonergic pathways. In Parkinson's Disease (PD), this multi-level system is compromised early on, leading to symptoms like axial rigidity and progressive postural instability.
Current standard treatments, such as Levodopa and Deep Brain Stimulation (DBS), often fail to address global balance dysfunction. While Levodopa may improve gait speed, it can paradoxically worsen postural sway and fails to significantly improve dynamic balance or dual-tasking. Therefore, there is a clinical need for interventions that target the balance network globally rather than in isolation.
Study Hypothesis The core hypothesis of this trial is that physical exercise that extensively and simultaneously challenges the distributed neural network of balance control is significantly more effective at improving multiple domains of balance in people with mild-to-moderate PD than simple exercise programs. Researchers propose that to achieve global improvement, the intervention must mimic the simultaneous demands of functional mobility in daily life. In this study, the Boxing-Based Balance and Agility Training (EBA-B) is utilized as a specific tool to operationalize this high-intensity, multidomain neural challenge.
Study Design This study is a randomized, crossover, controlled clinical trial. Participants are randomized into two groups (EF and EDU) which differ only in the order of the interventions received. The total study duration per participant is approximately 19 weeks, consisting of:
- Phase 1: 8 weeks of intervention (EBA-B or AC).
- Washout Period: 3 weeks of no study-related exercise to minimize carry-over effects.
- Phase 2: 8 weeks of the opposite intervention.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants were kept masked to the specific research question, the study hypothesis, and the detailed characteristics of the outcome measures to minimize expectation bias. Additionally, clinical evaluations using subjective balance and gait scales were video-recorded at each time point. These recordings were subsequently evaluated and scored by an independent investigator who was blinded to both the group assignment and the specific intervention phase (EBA-B or AC) being assessed.
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 25 years or older
- •Confirmed diagnosis of idiopathic Parkinson's Disease by a specialist physician
- •Parkinson's Disease severity stage between I and III on the Hoehn and Yahr scale
- •Current use of stable doses of anti-parkinsonian medication
- •Ability to stand upright without assistance
- •Ability to walk independently at home for at least two minutes, with or without a walking aid
- •Not currently participating in any other specialized exercise program (such as non-contact boxing, Tai Chi, tango, or aquatic therapy)
- •Availability and means to attend in-person group sessions three times per week for eight weeks
排除标准
- •Currently undergoing the process of Parkinson's Disease diagnostic confirmation
- •Diagnosis of atypical parkinsonism
- •Other neurological conditions besides Parkinson's Disease
- •History of Deep Brain Stimulation (DBS) or other brain surgeries
- •Severe bone or muscle problems that prevent safe exercise
- •Uncontrolled heart or metabolic conditions that make exercise unsafe
- •Severe respiratory conditions or current COVID-19 (SARS-COV2) infection
研究组 & 干预措施
Group EDU: Active Control followed by EBA-B
Participants in this arm first receive 8 weeks of the Active Control (AC) intervention (education and home-based mobility exercises), followed by a 3-week washout period. Subsequently, they crossover to receive 8 weeks of the experimental boxing-based balance and agility training (EBA-B).
干预措施: Mobility and Education (AC). (Behavioral)
Group EF: EBA-B followed by Active Control
Participants in this arm first receive 8 weeks of the experimental boxing-based balance and agility training (EBA-B), followed by a 3-week washout period. Subsequently, they crossover to receive 8 weeks of the Active Control (AC) intervention, which consists of education sessions and home-based mobility exercises.
干预措施: Boxing-Based Balance and Agility Training (EBA-B). (Behavioral)
Group EF: EBA-B followed by Active Control
Participants in this arm first receive 8 weeks of the experimental boxing-based balance and agility training (EBA-B), followed by a 3-week washout period. Subsequently, they crossover to receive 8 weeks of the Active Control (AC) intervention, which consists of education sessions and home-based mobility exercises.
干预措施: Mobility and Education (AC). (Behavioral)
Group EDU: Active Control followed by EBA-B
Participants in this arm first receive 8 weeks of the Active Control (AC) intervention (education and home-based mobility exercises), followed by a 3-week washout period. Subsequently, they crossover to receive 8 weeks of the experimental boxing-based balance and agility training (EBA-B).
干预措施: Boxing-Based Balance and Agility Training (EBA-B). (Behavioral)
结局指标
主要结局
Change from Baseline in Mini-Balance Evaluation Systems Test (MiniBESTest) Total Score
时间窗: Baseline, 8 weeks (end of Phase 1), and 19 weeks (end of Phase 2/Study Completion).
The MiniBESTest is a clinical rating scale used to assess four domains of balance: anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic balance. It consists of 14 items, each scored on an ordinal scale from 0 to 2. The total score ranges from 0 to 28 points, where 0 represents the greatest balance impairment and 28 represents typical, healthy balance performance.
Change from Baseline in Functional Gait Assessment (FGA) Total Score
时间窗: Baseline, 8 weeks (end of Phase 1), and 19 weeks (end of Phase 2/Study Completion).
The FGA is a clinical scale designed to assess postural stability during various walking tasks. It comprises 10 tasks, each rated from 0 to 3 points. The total score ranges from 0 to 30 points, where 0 indicates severe gait impairment and 30 indicates normal functional gait.
次要结局
- Change from Baseline in Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III)(Baseline, 8 weeks (end of Phase 1), and 19 weeks (end of Phase 2/Study Completion).)
- Change from Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index and Individual Domain Scores(Baseline, 8 weeks (end of Phase 1), and 19 weeks (end of Phase 2/Study Completion).)
- Change from Baseline in Activities-specific Balance Confidence (ABC) Scale(Baseline, 8 weeks (end of Phase 1), and 19 weeks (end of Phase 2/Study Completion).)
- Change from Baseline in First Step Range of Motion (ROM)(Baseline, 8 weeks (end of Phase 1), and 19 weeks (end of Phase 2/Study Completion).)
- Change from Baseline in Functional Gait Speed(Baseline, 8 weeks (end of Phase 1), and 19 weeks (end of Phase 2/Study Completion).)
- Change from Baseline in Instrumented Postural Sway Area(Baseline, 8 weeks (end of Phase 1), and 19 weeks (end of Phase 2/Study Completion).)
- Change from Baseline in Postural Movement Smoothness (Jerk)(Baseline, 8 weeks (end of Phase 1), and 19 weeks (end of Phase 2/Study Completion).)
- Change from Baseline in Dual-Task Cost (DTC) During Timed Up and Go (TUG) Test(Baseline, 8 weeks (end of Phase 1), and 19 weeks (end of Phase 2/Study Completion).)
研究者
Pablo Burgos
Principal Investigator, Ph.D., PT
University of Chile