Trial Outcomes & Findings for Kick Out Parkinson's Disease- Karate Intervention (NCT NCT03555695)
NCT ID: NCT03555695
Last Updated: 2023-10-12
Results Overview
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.
COMPLETED
NA
19 participants
10 weeks
2023-10-12
Participant Flow
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
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15
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
|
|
Overall Study
Lost to Follow-up
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1
|
|
Overall Study
appendicitis (unrelated)
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1
|
|
Overall Study
pre-existing sciatica
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1
|
Baseline Characteristics
Kick Out Parkinson's Disease- Karate Intervention
Baseline characteristics by cohort
| Measure |
Karate Class Participants
n=19 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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
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8 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=99 Participants
|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 10.8 • n=99 Participants
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|
Sex: Female, Male
Female
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10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
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9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
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16 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
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19 participants
n=99 Participants
|
|
Timed Up and Go
|
9.6 Seconds
STANDARD_DEVIATION 2.23 • n=99 Participants
|
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Parkinson's disease Quality of Life-short form
|
25.3 units on a scale
STANDARD_DEVIATION 20.8 • n=99 Participants
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PRIMARY outcome
Timeframe: 10 weeksPopulation: 15/19 participants completed the 10-week intervention
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.
Outcome measures
| Measure |
Karate Class Participants
n=15 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.
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|---|---|
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Change in Mobility as Measured by the Timed Up & Go (TUG)
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9.0 seconds
Standard Deviation 1.89
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SECONDARY outcome
Timeframe: 10 weeksThe 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.
Outcome measures
| Measure |
Karate Class Participants
n=15 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.
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|---|---|
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Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC)
"Almost the same"
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1 Participants
|
|
Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC)
"A little better"
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1 Participants
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Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC)
"Moderately better"
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8 Participants
|
|
Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC)
"Better, definite improvement"
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4 Participants
|
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Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC)
"Great deal better"
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1 Participants
|
SECONDARY outcome
Timeframe: 10 weeksPopulation: 15 participants completed intervention
Validated 8-item PD-specific health-related quality of life measure; lower scores (score range 0-100) indicate better quality of life
Outcome measures
| Measure |
Karate Class Participants
n=15 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.
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|---|---|
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Quality of Life - Parkinson's Disease Questionnaire Short Form (PDQ-8)
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19.3 score on a scale
Standard Deviation 19.6
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SECONDARY outcome
Timeframe: Ten weeksAttendance at twice weekly classes, measured by karate instructors
Outcome measures
| Measure |
Karate Class Participants
n=15 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.
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|---|---|
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Attendance at Twice Weekly Classes
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86.7 percentage of classes attended
Standard Deviation 9.9
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SECONDARY outcome
Timeframe: Ten weeksNumber of individuals answering "Yes"
Outcome measures
| Measure |
Karate Class Participants
n=15 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.
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|---|---|
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"Would You Recommend Karate Classes to Another Individual With Parkinson's Disease?"
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15 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: 10 weeksThe 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 weeksThe 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
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 weeksThe 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 weeksIn 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 10 weeksThe 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsDuring 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.
Outcome measures
| Measure |
Karate Class Participants
n=15 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.
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|---|---|
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Number of Participants Continuing to Attend Karate Classes
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8 Participants
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Adverse Events
Karate Class Participants
Serious adverse events
| Measure |
Karate Class Participants
n=19 participants at risk
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.
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|---|---|
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Gastrointestinal disorders
Appendicitis
|
5.3%
1/19 • Number of events 1 • 10 weeks
|
Other adverse events
| Measure |
Karate Class Participants
n=19 participants at risk
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.
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|---|---|
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Nervous system disorders
Exacerbation of pre-existing sciatica
|
5.3%
1/19 • Number of events 1 • 10 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place