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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04781842
Other study ID # HUSSONPT2021CLS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 10, 2021
Est. completion date April 18, 2022

Study information

Verified date March 2021
Source Husson University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date April 18, 2022
Est. primary completion date April 18, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Diagnosis of Parkinson Disease Exclusion Criteria: - Inability to walk without physical assistance

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Boxing exercise program
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.

Locations

Country Name City State
United States Husson University Bangor Maine

Sponsors (1)

Lead Sponsor Collaborator
Husson University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary Turning speed Involves timing the participant as they complete a 180 degree turn around a marker. 12 weeks
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