Kick Out Parkinson's Disease 2

Not Applicable

Completed

Conditions: Parkinson Disease

Interventions: Behavioral: Karate Classes
Behavioral: Pre-Intervention Study Visit
Behavioral: Bimonthly Online Survey
Behavioral: 6-month Study Visit
Behavioral: 12-month Study Visit

Registration Number: NCT03882879

Lead Sponsor: Rush University Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 52

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 2	Bimonthly Online Survey	Participants in Arm 2 will continue their usual exercise routine for six months followed by karate classes for six months
Arm 2	12-month Study Visit	Participants in Arm 2 will continue their usual exercise routine for six months followed by karate classes for six months
Arm 1	6-month Study Visit	Participants in Arm 1 will begin participation in 6 months of karate classes immediately after the pre-intervention study visits.
Arm 1	Bimonthly Online Survey	Participants in Arm 1 will begin participation in 6 months of karate classes immediately after the pre-intervention study visits.
Arm 1	12-month Study Visit	Participants in Arm 1 will begin participation in 6 months of karate classes immediately after the pre-intervention study visits.
Arm 1	Karate Classes	Participants in Arm 1 will begin participation in 6 months of karate classes immediately after the pre-intervention study visits.
Arm 1	Pre-Intervention Study Visit	Participants in Arm 1 will begin participation in 6 months of karate classes immediately after the pre-intervention study visits.
Arm 2	Karate Classes	Participants in Arm 2 will continue their usual exercise routine for six months followed by karate classes for six months
Arm 2	Pre-Intervention Study Visit	Participants in Arm 2 will continue their usual exercise routine for six months followed by karate classes for six months
Arm 2	6-month Study Visit	Participants in Arm 2 will continue their usual exercise routine for six months followed by karate classes for six months

Primary Outcome Measures

Name	Time	Method
Change in Mobility as Measured by the Timed Up & Go (TUG)	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC)	12 months	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, where 1 is "very much worse", 4 is "no change", and 7 is "very much improved". Percentages of subjects endorsing each of the 7 response options will be compared. This scale will be completed at the post-intervention focus group.