Kick Out Parkinson's Disease 2
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

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.
    

Intervention name(s): Karate Classes; Pre-Intervention Study Visit; Bimonthly Online Survey; 6-month Study Visit; 12-month Study Visit
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: This is a randomized, single-blinded, study of a novel intervention, namely, non-contact karate, for early to middle stage PD.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: karate; exercise; martial arts; Parkinson's Disease; non-pharmacologic; randomized trial; camaraderie; depression; anxiety; quality of life