Kick Out Parkinson's Disease 2

Karate Intervention to Change Kinematic Outcomes in Parkinson's Disease. KICK OUT 2: A Phase Two, Randomized Trial of a Karate Intervention

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.

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.

karate, exercise, martial arts, Parkinson's Disease, non-pharmacologic, randomized trial, camaraderie, depression, anxiety, quality of life

This is a randomized, single-blinded, study of a novel intervention, namely, non-contact karate, for early to middle stage PD.

Participants in Arm 1 will begin participation in 6 months of karate classes immediately after the pre-intervention study visits.

Participants in Arm 2 will continue their usual exercise routine for six months followed by karate classes for six months

Eligible subjects will engage in twice-weekly karate classes for 6 months, 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

At the pre-intervention study visit, the study logistics will be reviewed, informed consent process will occur, the subject will complete a battery of pre-intervention assessments focused on overall mobility, gait, balance, mood, cognition, and quality of life, and the subjects will be prompted to share their expectations of 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 have attended karate classes, how frequently they have engaged in exercise, how frequently they have fallen, whether their PD medication regimen has changed, and they will complete brief surveys about mood, camaraderie, and overall quality of life.

All participants in both arms will complete questionnaires and assessments of their PD symptoms, cognition, mood, camaraderie, and quality of life. Subjects will meet with a member of the study team to complete a series of physical and cognitive assessments. At this visit, subjects will review the initial expectations they shared at the pre-intervention visit and indicate if they thought their goals were achieved for the class.

At the 12-month study visit, the assessments from the baseline and 6-month study visit 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.

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.

The Patient Global Impression of Change Scale (PGIC) is a single-item rating scale that asks subjects to rate their overall response to the intervention using a 7-point rating scale. Percentages of subjects endorsing each of the 7 response options will be compared. This scale will be completed at the post-intervention focus group.

The Hospital Anxiety and Depression Scale (HADS) is a brief, 14-item highly validated scale for measuring anxiety (7 items) and depression (7 items), where scores of >8 for either anxiety or depression indicate probable symptoms. . Scores at the pre-intervention, 6-month, and 12-month study visits will be compared.

The Parkinson's Disease Questionnaire- Short Form (PDQ-8) is validated and shortened version of the PDQ-39, with 8 items each representing one domain of the PDQ-39, also with a summary index score standardized to a scale of 0-100, with higher scores signifying worse quality of life; this scale is recommended for use in PD by the Movement Disorder Society.

In the Symbol Digit Modalities Test (SDMT), the subject uses a reference key to pair specific numbers with given abstract geometric figures in 90 seconds. Scores are the correct number of pairs made in 90 seconds, with greater scores indicating greater cognitive abilities. Scores at the preintervention, 6-month, and 12-month study visits will be compared.

The Digit Span Test (DST) tests the number of digits a subject can recall in the correct order after hearing them. The experimenter says numbers slowly at one second intervals. Subjects are asked to repeat the numbers in the order they were given. A subject's digit span is the number of items they are able to report back in order correctly. Scores at the preintervention, 6-month, and 12-month study visits will be compared.

A screening instrument designed to help health professionals detect mild cognitive dysfunction. Subjects will answer questions to measure different areas of cognition including attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation.

A measure of group cohesion used in sports psychology. This conceptual model of cohesion is a modified version of the GEQ (Group Environment Questionnaire). PAGEQ is divided into two levels of perceptions: an individual's perspective of a group as a whole (collective) and an individual's attraction to a group (personal). These two levels are further defined by social and task aspects. All these components are categorized into four constructs: Group Integration-Social (GI-S), Group Integration-Task (GI-T), Individual Attractions to the Group-Social (ATG-S), and Individual Attractions to the Group-Task (ATG-T).

A study team member will follow same procedure as the Timed Up & Go (TUG) described above. For the first trial, subjects will be instructed to walk 3 meters. During the second trial, the distance between the arm chair and a taped line will be increased to 7 meters.

A test to examine fatigue over time and that will also allow more accurate calculation of gait variability indices by increasing the number of steps. The subject will walk 25 meters, turn and walk back, and repeat this until 2 minutes has elapsed.

A test to assess balance and postural sway. Subjects will be asked to stand still with their hands across their chests and their feet positioned a set distance apart (scaled to their height) with a wearable sensor that records movements applied to the lumbar trunk. This sensor will record parameters including mean total sway area, path length, jerk, and sway distance in the mediolateral and anteroposterior directions.

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.