NCT04781842

Brief Summary

This study is investigating the impact of a boxing training program on people with Parkinson Disease. The investigators were provided data for the intervention group retrospectively by the organizers of the boxing club to assess participants' benefit from participation. The outcome measures were selected to measure different aspects of functional mobility. Of particular interest is the impact of challenging whole-body activities designed for boxing and their impact on turning speed and gait. The second phase of the study will gather control group information from people with Parkinson Disease who have not participated in a boxing program to compare differences in pre-test and post-test data over a period of 12 weeks. The specific population and study design are currently pending global pandemic restrictions. Subject recruitment will involve people who have never had access to a program of this nature. An alternative population for recruitment may involve the same participants from the boxing club in a crossover study format since the boxing club has been suspended for over a year due to health and safety concerns during the pandemic. The control group of either situation would be instructed to carry on with their daily activities as usual without changing their physical activity. We hypothesize that the intervention group would show greater improvements in functional mobility compared to the control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable parkinson-disease

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable parkinson-disease

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

April 10, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2022

Completed
Last Updated

March 27, 2023

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 1, 2021

Last Update Submit

March 24, 2023

Conditions

Keywords

boxingturning speed

Outcome Measures

Primary Outcomes (4)

  • Gait speed

    Gait speed is recorded as the participant walks their comfortable walking speed on a level surface with a marked 4 meter path. The participant begins 1 meter before the start line and continues walking 1 meter past the 4 meter line to prevent acceleration and deceleration from affecting their speed.

    12 weeks

  • 30 Second Sit to Stand Test

    The 30-second sit to stand test requires the participant to rise from a chair and sit back down without using their arms as many times as they can within 30 seconds. The number of completed rises is recorded. It is a measure of lower extremity functional strength.

    12 weeks

  • Timed Up and Go Test

    The Timed Up and Go Test involves having the participant rise from an arm chair, walk 10 feet around a marker on the floor, and return to sitting in the chair. The time of completion is recorded.

    12 weeks

  • Turning speed

    Involves timing the participant as they complete a 180 degree turn around a marker.

    12 weeks

Study Arms (2)

Boxing Club Group

EXPERIMENTAL

Participation in a weekly boxing program designed for people with Parkinson Disease

Other: Boxing exercise program

Control group

NO INTERVENTION

No changes to regular physical activity during the study period

Interventions

Participants attended an hour long class once a week for 12 weeks. Included in class was a warm up, boxing activities including weight shifting, kicking, and punching bags, strengthening activities and a cool down.

Boxing Club Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Parkinson Disease

You may not qualify if:

  • Inability to walk without physical assistance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Husson University

Bangor, Maine, 04401, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Data will be deidentified prior to be provided for data analysis.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Pretest-posttest control group design. The intervention group is based on retrospective data provided to the investigators. The control group will be recruited from a population where a boxing program is not available.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 4, 2021

Study Start

April 10, 2021

Primary Completion

April 18, 2022

Study Completion

April 18, 2022

Last Updated

March 27, 2023

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will share

Anticipate sharing all data at the conclusion of the study.

Shared Documents
STUDY PROTOCOL
Time Frame
The data will be available within 6 months of the conclusion of the study.
Access Criteria
Unrestricted

Locations