Kick Out Parkinson's Disease

Karate Intervention to Change Kinematic Outcomes in Parkinson's Disease

Sponsors

Lead Sponsor: Rush University Medical Center

Source Rush University Medical Center
Brief Summary

The benefits of exercise for general health and wellbeing in older adults are well-established. Balance exercises such as tai chi and yoga, along with resistance training, can improve or maintain physical function in older adults and enhance muscle strength. Furthermore, aerobic activity is critical for maintaining and improving cardiovascular and functional health. Noncontact boxing has recently seen a surge in popularity among individuals with Parkinson's Disease (PD), with components of both aerobic and balance exercise. While participants anecdotally note improvements in stress and physical function, this has only been minimally studied. However, drawing on this experience and the combined aerobic, balance, and mindfulness practices that comprise karate, we hypothesize that participation in structured karate programs may offer similar or greater benefits. Specifically, the aim of this study is to test whether and to what degree a community-based karate class tailored for individuals with early- to middle-stage Parkinson's Disease (PD) 1) is feasible; and 2) improves objective and patient-reported outcomes.

Detailed Description

For 10 weeks, eligible subjects will engage in twice-weekly karate classes, specifically designed for individuals with early to middle stage PD, focused on incorporating upper and lower limb movements in multiple directions, increasing awareness throughout the body, shifting body weight and rotation, relaxation of the muscles, improving reaction time, using complex repetitive actions to improve coordination, footwork training and centered weight shifts to help with fall prevention, and striking shields for self-defense and stress relief. Before beginning the karate classes, each subject will attend a pre-intervention focus group during which subjects will complete an assessment focused on overall mobility, gait, balance, mood, and quality of life. Subjects will be prompted to share their thoughts on exercise, balance, and mindfulness practices in general and in PD specifically. Following the 10 weeks of twice-weekly karate classes, subjects will attend a post-intervention assessment and focus group during which the pre-intervention assessments will be repeated and the subject's impressions about the karate classes and their effectiveness will be measured. Finally, the study team will contact subjects 6 months post-intervention to assess continued engagement in karate or related activities and again, the subject's quality of life and global impression of change.

Overall Status Completed
Start Date 2018-06-18
Completion Date 2019-03-31
Primary Completion Date 2018-09-06
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in mobility as measured by the Timed Up & Go (TUG) 10 weeks
Secondary Outcome
Measure Time Frame
Change in overall well-being as measured by the Patient Global Impression of Change Scale (PGIC) 10 weeks
Enrollment 19
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Karate Classes

Description: Eligible subjects will engage in twice-weekly karate classes for 10 weeks, specifically designed for individuals with early to middle stage PD, focused on incorporating upper and lower limb movements in multiple directions, increasing awareness throughout the body, shifting body weight and rotation, relaxation of the muscles, improving reaction time, using complex repetitive actions to improve coordination, footwork training and centered weight shifts to help with fall prevention, and striking shields for self-defense and stress relief.

Arm Group Label: Karate Class Participants

Intervention Type: Behavioral

Intervention Name: Pre-Intervention Focus Group

Description: At the pre-intervention focus group, the study logistics will be reviewed, informed consent process will occur, the subject will complete a brief, individual pre-intervention assessment focused on overall mobility, gait, balance, mood, neurological status, and quality of life, and the subjects will be prompted to share aloud their thoughts on exercise, balance, and mindfulness practices in general and in PD specifically, and any expectations or preconceptions that they have regarding karate classes for PD.

Arm Group Label: Karate Class Participants

Intervention Type: Behavioral

Intervention Name: Post-Intervention Focus Group

Description: At the post-intervention focus group, the pre-intervention assessments will be readministered, along with an assessment of the subject's global impression of change. Subjects will be prompted to share their thoughts on how the intervention impacted their overall wellbeing, balance, and mindfulness; whether the intervention achieved their expectations; and they will be asked to provide feedback for improvements.

Arm Group Label: Karate Class Participants

Eligibility

Criteria:

Inclusion Criteria: - Subjects will be those diagnosed with Parkinson's Disease by a treating neurologist; if the subject is seen at Rush University Medical Center, this will be verified via chart review. If the subject is seen elsewhere, he or she will be asked to have their neurologist sign a form confirming the diagnosis of Parkinson's Disease and indicating the subject's HY stage (with definitions of each stage provided on the form for providers who may not be familiar with HY staging) at the most recent visit, to be sent back to the study coordinator for eligibility verification. - English speaking - Living within the Chicago area - Subjects may be untreated for Parkinson's Disease, or may be taking any individual PD medication or combination thereof. Subjects may or may not have had Deep Brain Stimulation. Subjects may or may not be receiving physical or occupational therapy. Subjects will be encouraged to maintain their same medication regimen throughout the duration of the 10-week study, however if emergent issues arise requiring medication changes, the subject will not be disqualified. Exclusion Criteria: - Subjects requiring an assistive device (cane, walker, wheelchair) or the assistance of another person in order to ambulate. - Subjects with active psychosis or exhibiting symptoms of a severe psychiatric disorder. - Subjects unable to commit to attending, or to travel to, two classes weekly for 10 weeks. - Subjects previously participating in a karate or other martial arts program, including boxing programs for PD, in the past 30 days. - Subjects with atypical parkinsonism, including Progressive Supranuclear Palsy, Multiple System Atrophy, Dementia with Lewy Bodies, Corticobasal Syndrome, drug-induced parkinsonism, vascular parkinsonism, or atypical parkinsonism not otherwise specified, according to the referring neurologist.

Gender:

All

Minimum Age:

30 Years

Maximum Age:

90 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Jori Fleisher, MD Principal Investigator Rush University Medical Center
Location
Facility: Rush University Medical Center
Location Countries

United States

Verification Date

2020-10-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Karate Class Participants

Type: Experimental

Description: Eligible subjects will engage in twice-weekly karate classes for 10 weeks, specifically designed for individuals with early to middle stage PD. Subjects will also complete an in-person pre-intervention focus group and post-intervention focus group, as well as a 6 month post-intervention follow up phone call.

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Intervention Model Description: This is a non-randomized, open-label, non-blinded, 10-week pilot study of a novel intervention, namely, non-contact karate, for early to middle stage PD.

Primary Purpose: Prevention

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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