Fundación Unión Parkinson Bío Bío
Concepción, Bío Bío, 4030000, Chile
NCT Number: NCT07835230
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
Looking for future studies?
Notify Me25 year and older
All sexes
Interventional
Not applicable
Concepción, Bío Bío, 4030000, Chile
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:
Intervention Protocols
Monitoring and Safety Clinical evaluations are performed in the "ON" medication state at three time points: Baseline (0M), Mid-point/Washout (2M), and Study Completion (4M). Participants are instructed to maintain stable medication and daily activity levels throughout the study. Adverse events, such as falls or musculoskeletal injuries, are recorded via participant diaries and direct reporting during sessions.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This intervention is a specialized multidomain exercise program designed to extensively and simultaneously challenge the brain's balance control network.
This active control intervention provides a partial challenge to the balance network through simpler movements and social interaction.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 8 weeks (end of Phase 1), and 19 weeks (end of Phase 2/Study Completion).
This scale measures the severity of motor symptoms in individuals with Parkinson's Disease. It involves a clinical examination of motor functions such as tremors, rigidity, and bradykinesia. The total score is the sum of all items; a higher score indicates greater motor symptom severity and a lower score indicates fewer symptoms.
Time frame: Baseline, 8 weeks (end of Phase 1), and 19 weeks (end of Phase 2/Study Completion).
The PDQ-39 is a self-administered questionnaire used to evaluate the impact of Parkinson's Disease on health-related quality of life. It consists of 39 items covering 8 distinct dimensions:
Scores for each of the 8 domains and the overall Summary Index (SI) are calculated on a scale from 0 to 100, where 0 represents the best possible health status (no impact or limitations) and 100 represents the worst health-related quality of life. The study analyzed changes from baseline in the global summary index and in each dimension separately to detect domain-specific therapeutic effects.
Time frame: Baseline, 8 weeks (end of Phase 1), and 19 weeks (end of Phase 2/Study Completion).
This scale measures the participant's level of confidence in maintaining balance while performing 16 specific daily activities. Each activity is rated on a percentage scale from 0% (no confidence) to 100% (complete confidence). The final score is the average percentage of all items, where higher percentages indicate greater balance confidence.
Time frame: Baseline, 8 weeks (end of Phase 1), and 19 weeks (end of Phase 2/Study Completion).
An objective mobility metric of Anticipatory Postural Adjustments (APA) obtained using APDM® Opal inertial sensors (placed on feet and lumbar region) during gait initiation[5][6]. Measured in degrees (°), where higher values indicate greater angular displacement of the ankle and improved APA magnitude.
Time frame: Baseline, 8 weeks (end of Phase 1), and 19 weeks (end of Phase 2/Study Completion).
An objective spatiotemporal gait metric captured via APDM® Opal inertial sensors during a 10-meter Walk Test in single task. Measured in meters per second (m/s), where higher values represent faster functional walking speed.
Time frame: Baseline, 8 weeks (end of Phase 1), and 19 weeks (end of Phase 2/Study Completion).
An objective postural stability metric captured via APDM® Opal inertial sensors (lumbar sensor) during dynamic and static balance tasks. Measured in centimeters squared (cm²), where lower values indicate reduced body sway and better postural control.
Time frame: Baseline, 8 weeks (end of Phase 1), and 19 weeks (end of Phase 2/Study Completion).
An objective metric quantifying the fluidity of postural control, captured via the lumbar APDM® Opal inertial sensor during balance tasks. Measured in meters squared per second to the fifth power (m²/s⁵), where lower values represent smoother movement and reduced postural instability.
Time frame: Baseline, 8 weeks (end of Phase 1), and 19 weeks (end of Phase 2/Study Completion).
An objective mobility metric evaluating cognitive-motor interference during dynamic balance and gait. Participants performed the Timed Up and Go (TUG) test under single-task and dual-task (performing a concurrent cognitive task) conditions while wearing APDM® Opal inertial sensors. Dual-Task Cost is calculated as a percentage using the standard relative formula: [(Dual-Task TUG Duration - Single-Task TUG Duration) / Single-Task TUG Duration] × 100. Reported in percentage (%), where lower or negative values represent less motor performance degradation during dual-tasking (i.e., superior cognitive-motor integration).
University of Chile
Other
Challenging Physical Exercise to Improve Balance: Effects of Multidomain Boxing-Based Training in People With Parkinson's Disease
Acronym: EBA-B
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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