Parkinson DiseaseNCT04781842
Effect of a Boxing Program on People With Parkinson Disease
A study testing Boxing exercise program in people with Parkinson Disease, run by Husson University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Boxing exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2021to 18 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Parkinson Disease
Who cannot join
- Inability to walk without physical assistance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Boxing Exercise Program on Turning Speed, Gait Speed, and Functional Lower Extremity Strength in People With Parkinson Disease
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Boxing exercise program
- Keywords
- boxing, turning speed
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boxing exercise programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Boxing Club Group | Experimental | Participation in a weekly boxing program designed for people with Parkinson Disease Receives: Other: Boxing exercise program |
| Control group | No intervention | No changes to regular physical activity during the study period |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Turning speed
Involves timing the participant as they complete a 180 degree turn around a marker.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start10 Apr 2021
- Primary completion18 Apr 2022
- Study completion18 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Husson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781842
- Sponsor's protocol ID
- HUSSONPT2021CLS
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2021
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anticipate sharing all data at the conclusion of the study.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Boxing Exercise Program on Turning Speed, Gait Speed, and Functional Lower Extremity Strength in People With Parkinson Disease
- ClinicalTrials.gov ID
- NCT04781842
- Acronym / sponsor ID
- HUSSONPT2021CLS
- Conditions
- Parkinson Disease
- Keywords
- boxing, turning speed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Husson UniversityUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 18 Apr 2022 (actual)
- Study completion
- 18 Apr 2022 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Boxing Club Group | Experimental | Other: Boxing exercise programParticipation in a weekly boxing program designed for people with Parkinson Disease |
| Control group | No intervention | –No changes to regular physical activity during the study period |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Parkinson Disease
Key exclusion criteria (1 listed)
- Inability to walk without physical assistance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boxing exercise programParticipants 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. | Other | Boxing Club Group |
Primary outcome
Gait speed
Time frame: 12 weeks
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
Time frame: 12 weeks
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
Time frame: 12 weeks
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
Time frame: 12 weeks
Involves timing the participant as they complete a 180 degree turn around a marker.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Individual participant dataSharing planned: Yes. Anticipate sharing all data at the conclusion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boxing exercise program in people with Parkinson Disease, run by Husson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023.