Kick Out Parkinson's Disease 2
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Parkinsons Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 30 - 90 |
| Updated: | 3/22/2019 |
| Start Date: | March 3, 2019 |
| End Date: | April 30, 2020 |
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.
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.
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.
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.
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