NCT07835230

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 22, 2026

Completed
Last Updated

September 22, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 11, 2026

Last Update Submit

September 18, 2026

Conditions

Keywords

Postural BalanceBoxingExercise TherapyGaitNeurological RehabilitationMobilityAgilityBalance

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline in Mini-Balance Evaluation Systems Test (MiniBESTest) Total Score

    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.

    Baseline, 8 weeks (end of Phase 1), and 19 weeks (end of Phase 2/Study Completion).

  • Change from Baseline in Functional Gait Assessment (FGA) Total Score

    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.

    Baseline, 8 weeks (end of Phase 1), and 19 weeks (end of Phase 2/Study Completion).

Secondary Outcomes (8)

  • 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).

  • +3 more secondary outcomes

Study Arms (2)

Group EF: EBA-B followed by Active Control

EXPERIMENTAL

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.

Behavioral: Boxing-Based Balance and Agility Training (EBA-B).Behavioral: Mobility and Education (AC).

Group EDU: Active Control followed by EBA-B

EXPERIMENTAL

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).

Behavioral: Boxing-Based Balance and Agility Training (EBA-B).Behavioral: Mobility and Education (AC).

Interventions

This intervention is a specialized multidomain exercise program designed to extensively and simultaneously challenge the brain's balance control network. * Frequency: 50-minute group sessions, 3 times per week for 8 weeks (24 sessions total). * Structure: Organized into two 4-week blocks: a Learning Block for technical acquisition and an Integration Block where exercise complexity and volume increase. * Session Layout: Includes a warm-up, three 12-minute work stations focusing on boxing techniques (punches and footwork), speed, and agility drills, followed by a cool-down. * Intensity: Progressively increases from 40% to 75% of maximum heart rate, monitored via pulse oximetry.

Group EDU: Active Control followed by EBA-BGroup EF: EBA-B followed by Active Control

This active control intervention provides a partial challenge to the balance network through simpler movements and social interaction. * Total Volume: 150 minutes per week, matching the EBA-B volume. * Education Component: Weekly 50-minute in-person group sessions led by specialists, covering topics related to Parkinson's Disease and quality of life. * Mobility Component: 20-minute home-based exercise sessions performed 5 times per week. These are simple, low-intensity mobility drills performed in a seated position (chair-based) following a video-recorded guide.

Group EDU: Active Control followed by EBA-BGroup EF: EBA-B followed by Active Control

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fundación Unión Parkinson Bío Bío

Concepción, Bío Bío, 4030000, Chile

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Range of Motion, ArticularEducational Status

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Pablo I Burgos, PhD

    University of Chile

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Ph.D., PT

Study Record Dates

First Submitted

September 11, 2026

First Posted

September 22, 2026

Study Start

November 23, 2022

Primary Completion

December 6, 2023

Study Completion

March 1, 2024

Last Updated

September 22, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

All the collected IPD.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
After the publication of the clinical trial, for 5 years.
Access Criteria
Based on reasonable request to the project director (Pablo Burgos, pburgos@uchile.cl) and the principal investigator (Miguel Pino, mmpinogar@gmail.com), the data will be shared.

Locations