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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Participants in Arm 1 will begin participation in 6 months of karate classes immediately after the pre-intervention study visits. |
|
| Arm 2 | Experimental | Participants in Arm 2 will continue their usual exercise routine for six months followed by karate classes for six months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Karate Classes | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jori Fleisher, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38588457 | Derived | Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3. | |
| 36602886 |
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Baseline study visit and assessments completed after enrollment and prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Fifty two individuals enrolled; randomized 27 (Arm 1) to 25 (Arm 2)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants evaluated at 12 month study visit. | Posted | Mean | Standard Deviation | seconds | 12 months |
|
1 year
No difference from clinicaltrials.gov description
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | Systematic Assessment | Urinary tract infection; deemed unrelated to study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foot injury | Musculoskeletal and connective tissue disorders | Systematic Assessment | Stress injury to foot |
12-month study visits were initially scheduled in the weeks immediately before and after COVID lockdowns, such that many participants were unable to complete the 12-month visits in-person and the primary outcome (Timed Up and Go) could not be assessed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jori Fleisher | Rush University Medical Center | 13125632900 | jori_fleisher@rush.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 19, 2020 | Dec 19, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009043 | Motor Activity |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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This is a randomized, single-blinded, study of a novel intervention, namely, non-contact karate, for early to middle stage PD.
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|
| Pre-Intervention Study Visit | Behavioral | 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. |
|
| Bimonthly Online Survey | Behavioral | 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. |
|
| 6-month Study Visit | Behavioral | 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. |
|
| 12-month Study Visit | Behavioral | 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. |
|
| 12 months |
| 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. | 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. | 12 months |
| Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Prior experience in karate | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
|
| 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. | 17 participants in arm 1 and 12 in arm 2 completed PGIC scale; means compared at 12 months. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
|
| 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. | Participants completed the measure at baseline, 6, and 12 months. Analysis here includes within- and between-group differences at 12 months. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
|
| 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. | 16 participants in arm 1 and 12 in arm 2 had MoCA data complete at both baseline and 12 months. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
|
| 0 |
| 27 |
| 2 |
| 27 |
| 0 |
| 27 |
| EG001 | 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. | 0 | 25 | 1 | 25 | 1 | 25 |
|
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment | Deemed unrelated to study |
|
| Surgery | General disorders | Systematic Assessment | Family member reported participant had surgery out of state, would not disclose underlying condition. Study team attempted to reach participant four more times without response |
|
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001519 | Behavior |
| D001526 | Behavioral Symptoms |
| D001523 | Mental Disorders |