Parkinson Disease
Conditions
Keywords
karate, exercise
Brief summary
The benefits of exercise for general health and wellbeing 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. Noncontact 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. However, drawing on this experience and the combined aerobic, balance, and mindfulness practices that comprise karate, we hypothesize that participation in structured karate programs may offer similar or greater benefits. Specifically, 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; and 2) improves objective and patient-reported outcomes.
Detailed description
For 10 weeks, 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. Before beginning the karate classes, each subject will attend a pre-intervention focus group during which subjects will complete an assessment focused on overall mobility, gait, balance, mood, and quality of life. Subjects will be prompted to share their thoughts on exercise, balance, and mindfulness practices in general and in PD specifically. Following the 10 weeks of twice-weekly karate classes, subjects will attend a post-intervention assessment and focus group during which the pre-intervention assessments will be repeated and the subject's impressions about the karate classes and their effectiveness will be measured. Finally, the study team will contact subjects 6 months post-intervention to assess continued engagement in karate or related activities and again, the subject's quality of life and global impression of change.
Interventions
BEHAVIORALKarate Classes
Eligible subjects will engage in twice-weekly karate classes for 10 weeks, 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.
BEHAVIORALPre-Intervention Focus Group
At the pre-intervention focus group, the study logistics will be reviewed, informed consent process will occur, the subject will complete a brief, individual pre-intervention assessment focused on overall mobility, gait, balance, mood, neurological status, and quality of life, and the subjects will be prompted to share aloud their thoughts on exercise, balance, and mindfulness practices in general and in PD specifically, and any expectations or preconceptions that they have regarding karate classes for PD.
BEHAVIORALPost-Intervention Focus Group
At the post-intervention focus group, the pre-intervention assessments 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.
Sponsors
Rush University Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a non-randomized, open-label, non-blinded, 10-week pilot study of a novel intervention, namely, non-contact karate, for early to middle stage PD.
Eligibility
Sex/Gender
ALL
Age
30 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Subjects will be those diagnosed with Parkinson's Disease by a treating neurologist; 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 neurologist sign a form confirming the diagnosis of Parkinson's Disease and indicating the subject's HY stage (with definitions of each stage provided on the form for providers who may not be familiar with HY staging) at the most recent visit, to be sent back to the study 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 10-week study, however if emergent issues arise requiring medication changes, the subject will not be disqualified.
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 10 weeks. * 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 neurologist.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mobility as Measured by the Timed Up & Go (TUG) | 10 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC) | 10 weeks | 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. |
| Quality of Life - Parkinson's Disease Questionnaire Short Form (PDQ-8) | 10 weeks | Validated 8-item PD-specific health-related quality of life measure; lower scores (score range 0-100) indicate better quality of life |
| Attendance at Twice Weekly Classes | Ten weeks | Attendance at twice weekly classes, measured by karate instructors |
| Would You Recommend Karate Classes to Another Individual With Parkinson's Disease? | Ten weeks | Number of individuals answering Yes |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Balance Abilities as Measured by the Functional Reach Test (FRT) | 10 weeks | The Functional Reach Test (FRT) is a brief, valid, reliable, and practical assessment of balance. This test involves a yardstick being mounted on a wall at shoulder height. The subject is asked to stand next to the yardstick, extend the arm closest to the wall at 90 degrees of shoulder flexion, and the distance is recorded. The subject is then asked to reach as far as he or she can forward without taking a step, and the distance is recorded again. The difference between start and end position is the reach distance. Greater reach distances indicate better balance. Scores at the pre- and post-intervention focus groups will be compared. |
| Number of Participants Continuing to Attend Karate Classes | 6 months | During the six month follow-up phone call, subjects will be asked whether they have continued to participate in any structured karate or martial arts classes. If yes, frequency and location of these classes will be asked. If no, reasons for lack of participation will be asked. Larger numbers of yes responses would indicate program sustainability. |
| Change in Balance Abilities as Measured by the Tinetti Mobility Test (TMT) | 10 weeks | The Tinetti Mobility Test (TMT) consists of 2 subscales: balance tests (9 items, scored from 0-16) and gait tests (7 items, scored from 0-12), where higher scores reflect better performance. Scores at the pre- and post-intervention focus groups will be compared |
| Change in Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS) | 10 weeks | 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- and post-intervention focus groups will be compared. |
| Change in Cognitive Abilities as Measured by the Symbol Digit Modalities Test (SDMT) | 10 weeks | 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 pre-and post-intervention focus groups will be compared. |
| Change in Short-term Memory Abilities as Measured by the Digit Span Test (DST) | 10 weeks | 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 pre-and post-intervention focus groups will be compared. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Karate Class Participants Eligible subjects will engage in twice-weekly karate classes for 10 weeks, specifically designed for individuals with early to middle stage PD. Subjects will complete in-person pre- and post-intervention focus groups, and a 6 month post-intervention follow up phone call.
Pre-Intervention Focus Group: Study logistics will be reviewed, informed consent process will occur, the subject will complete a brief, individual pre-intervention assessment focused on overall mobility, gait, balance, mood, neurological status, and quality of life. Subjects will be prompted to share their thoughts on exercise, balance, and mindfulness practices in general and in PD specifically, and any expectations they have regarding karate for PD.
Karate Classes: Specifically designed for individuals with early to middle stage PD, focused on incorporating limb movements in multiple directions, increasing body awareness, shifting body weight and rotation, muscle relaxation, 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.
Post-Intervention Focus Group: Pre-intervention assessments will be readministered, along with global impression of change. Subjects will be asked their thoughts on how the intervention impacted overall wellbeing, balance, and mindfulness; whether the intervention met their expectations; and to provide feedback. | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | appendicitis (unrelated) | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | pre-existing sciatica | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Karate Class Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 63.1 years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Parkinson's disease Quality of Life-short form | 25.3 units on a scale STANDARD_DEVIATION 20.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 9 Participants |
| Timed Up and Go | 9.6 Seconds STANDARD_DEVIATION 2.23 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 19 |
| other Total, other adverse events | 1 / 19 |
| serious Total, serious adverse events | 1 / 19 |
Outcome results
Primary
Change in Mobility as Measured by the Timed Up & Go (TUG)
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.
Time frame: 10 weeks
Population: 15/19 participants completed the 10-week intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Karate Class Participants | Change in Mobility as Measured by the Timed Up & Go (TUG) | 9.0 seconds | Standard Deviation 1.89 |
p-value: 0.12t-test, 2 sided
Secondary
Attendance at Twice Weekly Classes
Attendance at twice weekly classes, measured by karate instructors
Time frame: Ten weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Karate Class Participants | Attendance at Twice Weekly Classes | 86.7 percentage of classes attended | Standard Deviation 9.9 |
Secondary
Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC)
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.
Time frame: 10 weeks
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Karate Class Participants | Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC) | Almost the same | 1 Participants |
| Karate Class Participants | Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC) | A little better | 1 Participants |
| Karate Class Participants | Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC) | Moderately better | 8 Participants |
| Karate Class Participants | Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC) | Better, definite improvement | 4 Participants |
| Karate Class Participants | Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC) | Great deal better | 1 Participants |
Secondary
Quality of Life - Parkinson's Disease Questionnaire Short Form (PDQ-8)
Validated 8-item PD-specific health-related quality of life measure; lower scores (score range 0-100) indicate better quality of life
Time frame: 10 weeks
Population: 15 participants completed intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Karate Class Participants | Quality of Life - Parkinson's Disease Questionnaire Short Form (PDQ-8) | 19.3 score on a scale | Standard Deviation 19.6 |
Secondary
Would You Recommend Karate Classes to Another Individual With Parkinson's Disease?
Number of individuals answering Yes
Time frame: Ten weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Karate Class Participants | Would You Recommend Karate Classes to Another Individual With Parkinson's Disease? | 15 Participants |
Other Pre-specified
Change in Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS)
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- and post-intervention focus groups will be compared.
Time frame: 10 weeks
Other Pre-specified
Change in Balance Abilities as Measured by the Functional Reach Test (FRT)
The Functional Reach Test (FRT) is a brief, valid, reliable, and practical assessment of balance. This test involves a yardstick being mounted on a wall at shoulder height. The subject is asked to stand next to the yardstick, extend the arm closest to the wall at 90 degrees of shoulder flexion, and the distance is recorded. The subject is then asked to reach as far as he or she can forward without taking a step, and the distance is recorded again. The difference between start and end position is the reach distance. Greater reach distances indicate better balance. Scores at the pre- and post-intervention focus groups will be compared.
Time frame: 10 weeks
Other Pre-specified
Change in Balance Abilities as Measured by the Tinetti Mobility Test (TMT)
The Tinetti Mobility Test (TMT) consists of 2 subscales: balance tests (9 items, scored from 0-16) and gait tests (7 items, scored from 0-12), where higher scores reflect better performance. Scores at the pre- and post-intervention focus groups will be compared
Time frame: 10 weeks
Other Pre-specified
Change in Cognitive Abilities as Measured by the Symbol Digit Modalities Test (SDMT)
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 pre-and post-intervention focus groups will be compared.
Time frame: 10 weeks
Other Pre-specified
Change in Short-term Memory Abilities as Measured by the Digit Span Test (DST)
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 pre-and post-intervention focus groups will be compared.
Time frame: 10 weeks
Other Pre-specified
Number of Participants Continuing to Attend Karate Classes
During the six month follow-up phone call, subjects will be asked whether they have continued to participate in any structured karate or martial arts classes. If yes, frequency and location of these classes will be asked. If no, reasons for lack of participation will be asked. Larger numbers of yes responses would indicate program sustainability.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Karate Class Participants | Number of Participants Continuing to Attend Karate Classes | 8 Participants |