Parkinson Disease
Conditions
Keywords
karate, exercise, martial arts, Parkinson's Disease, non-pharmacologic, randomized trial, camaraderie, depression, anxiety, quality of life
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALKarate Classes
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
BEHAVIORALPre-Intervention Study Visit
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.
BEHAVIORALBimonthly Online Survey
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.
BEHAVIORAL6-month Study Visit
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.
BEHAVIORAL12-month Study Visit
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.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
This is a randomized, single-blinded, 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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mobility as Measured by the Timed Up & Go (TUG) | 12 months | 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) | 12 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in Depression as Measured by the Hospital Anxiety and Depression Scale | 12 months | 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. |
| Change in Quality of Life as Measured by the Parkinson's Disease Questionnaire- Short Form (PDQ-8) | 12 months | 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. |
| Change in Cognitive Domains as Measured by Montreal Cognitive Assessment | 12 months | 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. |
Countries
United States
Participant flow
Pre-assignment details
Baseline study visit and assessments completed after enrollment and prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Participants in Arm 1 will begin participation in 6 months of karate classes immediately after the pre-intervention study visits.
Karate Classes: Twice-weekly karate classes for 6 months, specifically designed for individuals with early to middle stage PD.
Pre-Intervention Study Visit: 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.
Bimonthly Online Survey: how frequently they have attended karate classes, engaged in exercise, and fallen; and whether their PD medication regimen has changed. Brief surveys about mood, camaraderie, and overall quality of life.
6-month Study Visit: Questionnaires and assessments of PD symptoms, cognition, mood, camaraderie, and quality of life; series of physical and cognitive assessments. 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.
12-month Study Visit: Assessments from the baseline and 6-month study visit will be readministered, plus subject's global impression of change. | 27 |
| Arm 2 Participants in Arm 2 will continue their usual exercise routine for six months followed by karate classes for six months
Karate Classes: Twice-weekly karate classes for 6 months, specifically designed for individuals with early to middle stage PD.
Pre-Intervention Study Visit: 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.
Bimonthly Online Survey: how frequently they have attended karate classes, engaged in exercise, and fallen; and whether their PD medication regimen has changed. Brief surveys about mood, camaraderie, and overall quality of life.
6-month Study Visit: Questionnaires and assessments of PD symptoms, cognition, mood, camaraderie, and quality of life; series of physical and cognitive assessments. 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.
12-month Study Visit: Assessments from the baseline and 6-month study visit will be readministered, plus subject's global impression of change. | 25 |
| Total | 52 |
Baseline characteristics
| Characteristic | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Age, Continuous | 65.56 years STANDARD_DEVIATION 8.98 | 65.94 years STANDARD_DEVIATION 9.82 | 65.74 years STANDARD_DEVIATION 9.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 24 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Prior experience in karate | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 18 Participants | 21 Participants | 39 Participants |
| Region of Enrollment United States | 27 participants | 25 participants | 52 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 17 Participants | 15 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 25 |
| other Total, other adverse events | 0 / 27 | 1 / 25 |
| serious Total, serious adverse events | 2 / 27 | 1 / 25 |
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: 12 months
Population: Participants evaluated at 12 month study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Change in Mobility as Measured by the Timed Up & Go (TUG) | Baseline | 9.66 seconds | Standard Deviation 1.62 |
| Arm 1 | Change in Mobility as Measured by the Timed Up & Go (TUG) | 12-month | 10.9 seconds | Standard Deviation 1.67 |
| Arm 2 | Change in Mobility as Measured by the Timed Up & Go (TUG) | Baseline | 9.19 seconds | Standard Deviation 1.56 |
| Arm 2 | Change in Mobility as Measured by the Timed Up & Go (TUG) | 12-month | 10.03 seconds | Standard Deviation 2.2 |
p-value: 0.64t-test, 2 sided
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, 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
Population: 17 participants in arm 1 and 12 in arm 2 completed PGIC scale; means compared at 12 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm 1 | Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC) | 5.47 score on a scale | Standard Deviation 1.18 |
| Arm 2 | Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC) | 5.75 score on a scale | Standard Deviation 1.14 |
p-value: 0.53t-test, 2 sided
Other Pre-specified
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
Population: 16 participants in arm 1 and 12 in arm 2 had MoCA data complete at both baseline and 12 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Change in Cognitive Domains as Measured by Montreal Cognitive Assessment | Baseline | 25.88 score on a scale | Standard Deviation 2.66 |
| Arm 1 | Change in Cognitive Domains as Measured by Montreal Cognitive Assessment | 12 months | 25.88 score on a scale | Standard Deviation 2.68 |
| Arm 2 | Change in Cognitive Domains as Measured by Montreal Cognitive Assessment | Baseline | 26.67 score on a scale | Standard Deviation 3.14 |
| Arm 2 | Change in Cognitive Domains as Measured by Montreal Cognitive Assessment | 12 months | 25.58 score on a scale | Standard Deviation 3.15 |
p-value: 0.2t-test, 2 sided
Other Pre-specified
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
Population: Participants completed the measure at baseline, 6, and 12 months. Analysis here includes within- and between-group differences at 12 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Change in Quality of Life as Measured by the Parkinson's Disease Questionnaire- Short Form (PDQ-8) | Baseline | 25.22 score on a scale | Standard Deviation 16.73 |
| Arm 1 | Change in Quality of Life as Measured by the Parkinson's Disease Questionnaire- Short Form (PDQ-8) | 12-month | 20.67 score on a scale | Standard Deviation 13.66 |
| Arm 2 | Change in Quality of Life as Measured by the Parkinson's Disease Questionnaire- Short Form (PDQ-8) | Baseline | 29.25 score on a scale | Standard Deviation 20.34 |
| Arm 2 | Change in Quality of Life as Measured by the Parkinson's Disease Questionnaire- Short Form (PDQ-8) | 12-month | 21 score on a scale | Standard Deviation 17.58 |
p-value: 0.49t-test, 2 sided
Other Pre-specified
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
Population: 17 participants in arm 1 and 12 in arm 2 completed HADS at both baseline and 12 months. Difference within- and between-groups at 12 months.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm 1 | Changes in Depression as Measured by the Hospital Anxiety and Depression Scale | Baseline | 4.53 score on a scale | Standard Deviation 3.18 |
| Arm 1 | Changes in Depression as Measured by the Hospital Anxiety and Depression Scale | 12 months | 3.59 score on a scale | Standard Deviation 2.62 |
| Arm 2 | Changes in Depression as Measured by the Hospital Anxiety and Depression Scale | Baseline | 4.08 score on a scale | Standard Deviation 3.23 |
| Arm 2 | Changes in Depression as Measured by the Hospital Anxiety and Depression Scale | 12 months | 2.92 score on a scale | Standard Deviation 2.94 |
p-value: 0.76t-test, 2 sided