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.