Kick Out Parkinson's Disease- Karate Intervention

NCT03555695 | Completed Results

• 1 other identifier: 18012313
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

karate; exercise

Outcome Measures

Primary Outcomes (1)

• Change in Mobility as Measured by the Timed Up & Go (TUG)

  The Timed Up \& Go (TUG) is a well-validated, brief measure of mobility. To complete this assessment, subjects sit in a standard arm chair and are instructed that when the team member says "Go", they should stand up from the chair, walk at their normal pace to a taped line, turn, walk back to their chair at a normal pace, and sit down again. The study team member will record the TUG results in seconds using a stopwatch. A lower TUG result indicates greater mobility. Scores at the pre- and post-intervention focus groups will be compared.

  10 weeks

Secondary Outcomes (4)

• Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC)

  10 weeks

• Quality of Life - Parkinson's Disease Questionnaire Short Form (PDQ-8)

  10 weeks

• Attendance at Twice Weekly Classes

  Ten weeks

• "Would You Recommend Karate Classes to Another Individual With Parkinson's Disease?"

  Ten weeks

Other Outcomes (6)

• Change in Balance Abilities as Measured by the Functional Reach Test (FRT)

  10 weeks

• Change in Balance Abilities as Measured by the Tinetti Mobility Test (TMT)

  10 weeks

• Change in Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS)

  10 weeks

Study Arms (1)

Karate Class Participants

EXPERIMENTAL

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.

Behavioral: Karate Classes; Behavioral: Pre-Intervention Focus Group; Behavioral: Post-Intervention Focus Group

Interventions

Karate Classes BEHAVIORAL

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.

Karate Class Participants

Pre-Intervention Focus Group BEHAVIORAL

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.

Karate Class Participants

Post-Intervention Focus Group BEHAVIORAL

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.

Karate Class Participants

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• 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.

  PMID: 32903267 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Results Point of Contact

• Title: Dr. Jori Fleisher
• Organization: Rush University Medical Center

jori_fleisher@rush.edu

312-563-2900

Study Officials

• Jori Fleisher, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 13, 2018
• Study Start: June 18, 2018
• Primary Completion: September 6, 2018
• Study Completion: March 31, 2019
• Last Updated: October 12, 2023
• Results First Posted: October 12, 2023

Record last verified: 2023-10

Locations

US (1)