Clinical trial NCT03882879: Kick Out Parkinson's Disease 2
Official title: Karate Intervention to Change Kinematic Outcomes in Parkinson's Disease. KICK OUT 2: A Phase Two, Randomized Trial of a Karate Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: karate
exercise
martial arts
Parkinson's Disease
non-pharmacologic
randomized trial
camaraderie
depression
anxiety
quality of life
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2019-03-20
Enrollment: 52
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is a randomized, single-blinded, 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 well-being 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. Non-contact 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. Therefore, we conducted a 10-week long pilot study of a structured karate exercise program. Among 15 participants, our pilot data highlights improvements in quality of life and high enthusiasm for the karate classes. Based on these promising results from the pilot, we are recruiting a larger, randomized group for the second phase of the karate intervention. 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; 2) improves objective outcomes such as mobility and balance; 3) improves patient-reported outcomes compared with individuals given a standard exercise prescription for PD.

Detailed description: For 6 months, 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.

Due to both the capacity of the karate classes and the scientific approach to detecting changes in PD, subjects will be randomly assigned into either Arm 1: immediate participation in the karate class or Arm 2: participation in usual exercise for six months followed by karate classes for six months. For participants in Arm 1, following the first six months of classes, subjects may choose to continue their participation in karate and in the study, though this will require paying membership fees at the karate studio. For participants in Arm 2, following the first six months of usual exercise, participants will then begin 6 months of twice-weekly classes.

Before beginning the karate classes, each subject will attend a pre-intervention study visit during which subjects will complete assessments focused on overall mobility, gait, balance, mood, and quality of life. Subjects will receive a one-time, in-person training in best practices for exercise in PD. Also subjects will be prompted to share their expectations and goals for the karate classes.

All participants in both arms will receive a personalized email every two months directing them to indicate how frequently they attended karate classes or engaged in exercise, and they will complete assessments of mood and quality of life.

Following six months of classes for Arm 1, and six months of usual exercise for Arm 2, subjects will meet with the study team to complete assessments of mobility, gait, balance, mood, and quality of life. Arm 1 will participate in a focus group to review initial expectations and goals for the class.

The 12-month study visit will occur once Arm 1 and Arm 2 have completed the intervention. The assessments from the pre-intervention and 6-month study visit will be repeated. Subjects will participate in a focus group to share their thoughts on whether they would recommend the classes and how to improve the overall experience.

Eligibility criteria: Inclusion Criteria:

* Subjects will be those diagnosed with Parkinson's Disease by a treating healthcare provider; 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 a healthcare provider sign a form confirming the diagnosis of Parkinson's Disease and indicating that the subject can ambulate independently as of the most recent visit, to be sent back to the research 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 study, however if issues arise requiring medication changes, the subject will be prompted to indicate medication changes in the bimonthly online survey, and will not be disqualified from study participation.

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 6 months.
* 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 healthcare provider.

Primary outcomes:
measure: Change in Mobility as Measured by the Timed Up & Go (TUG)
timeFrame: 12 months
Secondary outcomes:
measure: Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC)
timeFrame: 12 months
Other outcomes:
measure: Changes in Depression as Measured by the Hospital Anxiety and Depression Scale
timeFrame: 12 months
measure: Change in Quality of Life as Measured by the Parkinson's Disease Questionnaire- Short Form (PDQ-8)
timeFrame: 12 months
measure: Change in Cognitive Domains as Measured by Montreal Cognitive Assessment
timeFrame: 12 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: