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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

10 weeks

Results posted on

2023-10-12

Participant Flow

Participant milestones

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.
Overall Study
STARTED
19
Overall Study
COMPLETED
15
Overall Study
NOT COMPLETED
4

Reasons for withdrawal

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.
Overall Study
Withdrawal by Subject
1
Overall Study
Lost to Follow-up
1
Overall Study
appendicitis (unrelated)
1
Overall Study
pre-existing sciatica
1

Baseline Characteristics

Kick Out Parkinson's Disease- Karate Intervention

Baseline characteristics by cohort

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.
Age, Categorical
<=18 years
0 Participants
n=99 Participants
Age, Categorical
Between 18 and 65 years
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
Sex: Female, Male
Female
10 Participants
n=99 Participants
Sex: Female, Male
Male
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
16 Participants
n=99 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
n=99 Participants
Region of Enrollment
United States
19 participants
n=99 Participants
Timed Up and Go
9.6 Seconds
STANDARD_DEVIATION 2.23 • n=99 Participants
Parkinson's disease Quality of Life-short form
25.3 units on a scale
STANDARD_DEVIATION 20.8 • n=99 Participants

PRIMARY outcome

Timeframe: 10 weeks

Population: 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

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.
Change in Mobility as Measured by the Timed Up & Go (TUG)
9.0 seconds
Standard Deviation 1.89

SECONDARY outcome

Timeframe: 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.

Outcome measures

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.
Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC)
"Almost the same"
1 Participants
Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC)
"A little better"
1 Participants
Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC)
"Moderately better"
8 Participants
Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC)
"Better, definite improvement"
4 Participants
Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC)
"Great deal better"
1 Participants

SECONDARY outcome

Timeframe: 10 weeks

Population: 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

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.
Quality of Life - Parkinson's Disease Questionnaire Short Form (PDQ-8)
19.3 score on a scale
Standard Deviation 19.6

SECONDARY outcome

Timeframe: Ten weeks

Attendance at twice weekly classes, measured by karate instructors

Outcome measures

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.
Attendance at Twice Weekly Classes
86.7 percentage of classes attended
Standard Deviation 9.9

SECONDARY outcome

Timeframe: Ten weeks

Number of individuals answering "Yes"

Outcome measures

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.
"Would You Recommend Karate Classes to Another Individual With Parkinson's Disease?"
15 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

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.
Number of Participants Continuing to Attend Karate Classes
8 Participants

Adverse Events

Karate Class Participants

Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

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.
Gastrointestinal disorders
Appendicitis
5.3%
1/19 • Number of events 1 • 10 weeks

Other adverse events

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.
Nervous system disorders
Exacerbation of pre-existing sciatica
5.3%
1/19 • Number of events 1 • 10 weeks

Additional Information

Dr. Jori Fleisher

Rush University Medical Center

Phone: 312-563-2900

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place