An interventional study of Karate Classes and Pre-Intervention Study Visit in Parkinson Disease, sponsored by Rush University Medical Center. Completed at 1 site in United States. Open to participants aged 30 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-04-12.
Sponsored by Rush University Medical Center · Not applicable, Interventional, and Prevention
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.
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.
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This study's enrollment of 52 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
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Exclusion Criteria:
Participants in Arm 1 will begin participation in 6 months of karate classes immediately after the pre-intervention study visits.
Behavioral: Karate Classes · Behavioral: Pre-Intervention Study Visit · Behavioral: Bimonthly Online Survey · Behavioral: 6-month Study Visit · Behavioral: 12-month Study Visit
Participants in Arm 2 will continue their usual exercise routine for six months followed by karate classes for six months
Behavioral: Karate Classes · Behavioral: Pre-Intervention Study Visit · Behavioral: Bimonthly Online Survey · Behavioral: 6-month Study Visit · Behavioral: 12-month Study Visit
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.
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: 12 months
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, where 1 is "very much worse", 4 is "no change", and 7 is "very much improved". 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: 12 months
Changes in Depression as Measured by the Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale is a brief, 14-item highly validated scale for measuring anxiety (7 items) and depression (7 items), with each item scored 0-3, and reverse scoring for negatively framed items. Scores for each subscale are totaled and categorized as normal (0-7 points), borderline abnormal (8-10 points), and abnormal (11-21) points. Scores at the pre-intervention, 6-month, and 12-month study visits will be compared.
Time frame: 12 months
Change in Quality of Life as Measured by the Parkinson's Disease Questionnaire- Short Form (PDQ-8)
The Parkinson's Disease Questionnaire- Short Form (PDQ-8) is validated and shortened version of the PDQ-39, with 8 items each representing one domain of the PDQ-39, also with a summary index score standardized to a scale of 0-100, with higher scores signifying worse quality of life; this scale is recommended for use in PD by the Movement Disorder Society.
Time frame: 12 months
Change in Cognitive Domains as Measured by Montreal Cognitive Assessment
A screening instrument designed to help health professionals detect mild cognitive dysfunction. Subjects will answer questions to measure different areas of cognition including attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible range is 0 (severely cognitively impaired) to 30 (perfect), where scores 26 and higher indicate normal cognition, and scores less than 26 indicate mild cognitive impairment or dementia.
Time frame: 12 months
| Milestone | Arm 1 | Arm 2 |
|---|---|---|
| Started | 27 | 25 |
| 6-month visit | 19 | 20 |
| Completed | 18 | 12 |
| Not completed | 9 | 13 |
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.
| seconds | Arm 1 | Arm 2 |
|---|---|---|
| Baseline | 9.66 ± 1.62 | 9.19 ± 1.56 |
| 12-month | 10.9 ± 1.67 | 10.03 ± 2.2 |
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, where 1 is "very much worse", 4 is "no change", and 7 is "very much improved". Percentages of subjects endorsing each of the 7 response options will be compared. This scale will be completed at the post-intervention focus group.
| score on a scale | Arm 1 | Arm 2 |
|---|---|---|
| Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC) | 5.47 ± 1.18 | 5.75 ± 1.14 |
The Hospital Anxiety and Depression Scale is a brief, 14-item highly validated scale for measuring anxiety (7 items) and depression (7 items), with each item scored 0-3, and reverse scoring for negatively framed items. Scores for each subscale are totaled and categorized as normal (0-7 points), borderline abnormal (8-10 points), and abnormal (11-21) points. Scores at the pre-intervention, 6-month, and 12-month study visits will be compared.
| score on a scale | Arm 1 | Arm 2 |
|---|---|---|
| Baseline | 4.53 ± 3.18 | 4.08 ± 3.23 |
| 12 months | 3.59 ± 2.62 | 2.92 ± 2.94 |
The Parkinson's Disease Questionnaire- Short Form (PDQ-8) is validated and shortened version of the PDQ-39, with 8 items each representing one domain of the PDQ-39, also with a summary index score standardized to a scale of 0-100, with higher scores signifying worse quality of life; this scale is recommended for use in PD by the Movement Disorder Society.
| score on a scale | Arm 1 | Arm 2 |
|---|---|---|
| Baseline | 25.22 ± 16.73 | 29.25 ± 20.34 |
| 12-month | 20.67 ± 13.66 | 21 ± 17.58 |
A screening instrument designed to help health professionals detect mild cognitive dysfunction. Subjects will answer questions to measure different areas of cognition including attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible range is 0 (severely cognitively impaired) to 30 (perfect), where scores 26 and higher indicate normal cognition, and scores less than 26 indicate mild cognitive impairment or dementia.
| score on a scale | Arm 1 | Arm 2 |
|---|---|---|
| Baseline | 25.88 ± 2.66 | 26.67 ± 3.14 |
| 12 months | 25.88 ± 2.68 | 25.58 ± 3.15 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Arm 1 | 0/27 (0%) | 2/27 (7.4%) | 0/27 (0%) |
| Arm 2 | 0/25 (0%) | 1/25 (4%) | 1/25 (4%) |
| Event | Arm 1 | Arm 2 |
|---|---|---|
| SurgeryGeneral disorders | 0/27 | 1/25 |
| Urinary tract infectionInfections and infestations | 1/27 | 0/25 |
| HyponatremiaMetabolism and nutrition disorders | 1/27 | 0/25 |
| Event | Arm 1 | Arm 2 |
|---|---|---|
| Foot injuryMusculoskeletal and connective tissue disorders | 0/27 | 1/25 |
Fifty two individuals enrolled; randomized 27 (Arm 1) to 25 (Arm 2)
| Age, Continuous(years) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Mean | 65.56 ± 8.98 | 65.94 ± 9.82 | 65.74 ± 9.30 |
| Sex: Female, Male(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Female | 10 | 10 | 20 |
| Male | 17 | 15 | 32 |
| Ethnicity (NIH/OMB)(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Hispanic or Latino | 4 | 1 | 5 |
| Not Hispanic or Latino | 23 | 24 | 47 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 1 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 18 | 21 | 39 |
| More than one race | 2 | 1 | 3 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Region of Enrollment(participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| United States | 27 | 25 | 52 |
| Prior experience in karate(Participants) | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Count of participants | 3 | 3 | 6 |
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