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Effect of a Boxing Program on People With Parkinson Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Boxing exercise program
Sponsored by
Husson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring boxing, turning speed

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Parkinson Disease

Exclusion Criteria:

  • Inability to walk without physical assistance

Sites / Locations

  • Husson University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Boxing Club Group

Control group

Arm Description

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

No changes to regular physical activity during the study period

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 1, 2021
Last Updated
March 24, 2023
Sponsor
Husson University
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1. Study Identification

Unique Protocol Identification Number
NCT04781842
Brief Title
Effect of a Boxing Program on People With Parkinson Disease
Official Title
The Effect of a Boxing Exercise Program on Turning Speed, Gait Speed, and Functional Lower Extremity Strength in People With Parkinson Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 10, 2021 (Actual)
Primary Completion Date
April 18, 2022 (Actual)
Study Completion Date
April 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Husson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The effects of Parkinson Disease are progressive and cause limitations in functional mobility and quality of life. This is a disease that greatly impairs the motor system with key presentation of resting tremors, rigidity and bradykinesia. These impairments cause further deficiencies in gait and postural stability. Most notable is festinating gait that is exacerbated by direction changes and becomes a fall risk for patients. These physical limitations can manifest fear and avoidance behaviors in people that ultimately decrease quality of life. Activities that can improve balance, strength and coordination allow people to gain confidence in their ability to participate in their daily activities. The purpose of this study is to investigate the impact of a boxing training program on lower extremity functional strength, fall risk, gait speed, and turning speed for people with Parkinson Disease compared to a control group. Data for the intervention group has been provided retrospectively by the organizers of the boxing club. This initial data was collected by volunteers of the club at the initial session and then at 12 weeks for purposes of progress reporting to the members. Data was de-identified prior to receipt by the investigators. The next phase of this study will involve recruitment of participants for a control group from areas that do not have established boxing programs. Pre- and post-tests will be conducted over a span of 12 weeks. Outcome measures for the future control group will be the same as the original tools provided by the boxing club. These measures will assess lower extremity functional strength, fall risk, gait speed and turning speed. Baseline data will be taken using 30-second sit to stand, Timed Up-and-Go, 180° turning speed, and gait speed. During the 12 week period, participants will be instructed to avoid changing their physical activity. At the end of 12 weeks the post-testing will be completed. Those participants in the control group will receive a gift card for participation in the study. If pandemic concerns prevent the recruitment of new participants for a control group, an alternative approach will involve a cross-over design in which the original participants from the intervention group will serve as the control group. The boxing club will be approached to contact the twelve participants who provided intervention data. The boxing club has not been held since March, 2020 due to the pandemic restrictions. A control period for this group will be established over a twelve week period where they do not participate in any new changes to their physical activity. The same outcome measures will be collected at pre-test and twelve weeks later for post-testing. Due to the nature of the in-person testing, extra precautions regarding Covid-19 have been implemented including a Covid-19 and Other Communicable Disease consent form outlining expectations of the participants as well as precautions by the investigators. These extra initiatives include appropriate facial masks and face shields by everyone involved at all times at the study site, physical distancing between investigators and participants with exceptions made for safety reasons, and any other procedures established by the study site.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
boxing, turning speed

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
Data will be deidentified prior to be provided for data analysis.
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Boxing Club Group
Arm Type
Experimental
Arm Description
Participation in a weekly boxing program designed for people with Parkinson Disease
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No changes to regular physical activity during the study period
Intervention Type
Other
Intervention Name(s)
Boxing exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Gait speed
Description
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.
Time Frame
12 weeks
Title
30 Second Sit to Stand Test
Description
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.
Time Frame
12 weeks
Title
Timed Up and Go Test
Description
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.
Time Frame
12 weeks
Title
Turning speed
Description
Involves timing the participant as they complete a 180 degree turn around a marker.
Time Frame
12 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Parkinson Disease Exclusion Criteria: Inability to walk without physical assistance
Facility Information:
Facility Name
Husson University
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anticipate sharing all data at the conclusion of the study.
IPD Sharing Time Frame
The data will be available within 6 months of the conclusion of the study.
IPD Sharing Access Criteria
Unrestricted

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Effect of a Boxing Program on People With Parkinson Disease

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