Clinical trial NCT03555695: Kick Out Parkinson's Disease- Karate Intervention
Official title: Karate Intervention to Change Kinematic Outcomes in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: karate
exercise
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 19
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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

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.

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.

Primary outcomes:
measure: Change in Mobility as Measured by the Timed Up & Go (TUG)
timeFrame: 10 weeks
Secondary outcomes:
measure: Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC)
timeFrame: 10 weeks
measure: Quality of Life - Parkinson's Disease Questionnaire Short Form (PDQ-8)
timeFrame: 10 weeks
measure: Attendance at Twice Weekly Classes
timeFrame: Ten weeks
measure: "Would You Recommend Karate Classes to Another Individual With Parkinson's Disease?"
timeFrame: Ten weeks
Other outcomes:
measure: Change in Balance Abilities as Measured by the Functional Reach Test (FRT)
timeFrame: 10 weeks
measure: Change in Balance Abilities as Measured by the Tinetti Mobility Test (TMT)
timeFrame: 10 weeks
measure: Change in Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS)
timeFrame: 10 weeks
measure: Change in Cognitive Abilities as Measured by the Symbol Digit Modalities Test (SDMT)
timeFrame: 10 weeks
measure: Change in Short-term Memory Abilities as Measured by the Digit Span Test (DST)
timeFrame: 10 weeks
measure: Number of Participants Continuing to Attend Karate Classes
timeFrame: 6 months
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center
name: Jori Fleisher, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fleisher JE, Sennott BJ, Myrick E, Niemet CJ, Lee M, Whitelock CM, Sanghvi M, Liu Y, Ouyang B, Hall DA, Comella CL, Chodosh J. KICK OUT PD: Feasibility and quality of life in the pilot karate intervention to change kinematic outcomes in Parkinson's Disease. PLoS One. 2020 Sep 9;15(9):e0237777. doi: 10.1371/journal.pone.0237777. eCollection 2020.