Trial Outcomes & Findings for Kick Out Parkinson's Disease 2 (NCT NCT03882879)
NCT ID: NCT03882879
Last Updated: 2024-04-12
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
52 participants
Primary outcome timeframe
12 months
Results posted on
2024-04-12
Participant Flow
Baseline study visit and assessments completed after enrollment and prior to randomization.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
25
|
|
Overall Study
6-month Visit
|
19
|
20
|
|
Overall Study
COMPLETED
|
18
|
12
|
|
Overall Study
NOT COMPLETED
|
9
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Kick Out Parkinson's Disease 2
Baseline characteristics by cohort
| Measure |
Arm 1
n=27 Participants
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.
|
Arm 2
n=25 Participants
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.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
65.56 years
STANDARD_DEVIATION 8.98 • n=5 Participants
|
65.94 years
STANDARD_DEVIATION 9.82 • n=7 Participants
|
65.74 years
STANDARD_DEVIATION 9.30 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
25 participants
n=7 Participants
|
52 participants
n=5 Participants
|
|
Prior experience in karate
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Participants evaluated at 12 month study visit.
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 |
Arm 1
n=18 Participants
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.
|
Arm 2
n=12 Participants
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.
|
|---|---|---|
|
Change in Mobility as Measured by the Timed Up & Go (TUG)
Baseline
|
9.66 seconds
Standard Deviation 1.62
|
9.19 seconds
Standard Deviation 1.56
|
|
Change in Mobility as Measured by the Timed Up & Go (TUG)
12-month
|
10.9 seconds
Standard Deviation 1.67
|
10.03 seconds
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 17 participants in arm 1 and 12 in arm 2 completed PGIC scale; means compared at 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.
Outcome measures
| Measure |
Arm 1
n=17 Participants
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.
|
Arm 2
n=12 Participants
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.
|
|---|---|---|
|
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
|
5.75 score on a scale
Standard Deviation 1.14
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Arm 1
n=17 Participants
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.
|
Arm 2
n=12 Participants
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.
|
|---|---|---|
|
Changes in Depression as Measured by the Hospital Anxiety and Depression Scale
Baseline
|
4.53 score on a scale
Standard Deviation 3.18
|
4.08 score on a scale
Standard Deviation 3.23
|
|
Changes in Depression as Measured by the Hospital Anxiety and Depression Scale
12 months
|
3.59 score on a scale
Standard Deviation 2.62
|
2.92 score on a scale
Standard Deviation 2.94
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: Participants completed the measure at baseline, 6, and 12 months. Analysis here includes within- and between-group differences at 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.
Outcome measures
| Measure |
Arm 1
n=18 Participants
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.
|
Arm 2
n=12 Participants
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.
|
|---|---|---|
|
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
|
29.25 score on a scale
Standard Deviation 20.34
|
|
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
|
21 score on a scale
Standard Deviation 17.58
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: 16 participants in arm 1 and 12 in arm 2 had MoCA data complete at both baseline and 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.
Outcome measures
| Measure |
Arm 1
n=16 Participants
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.
|
Arm 2
n=12 Participants
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.
|
|---|---|---|
|
Change in Cognitive Domains as Measured by Montreal Cognitive Assessment
Baseline
|
25.88 score on a scale
Standard Deviation 2.66
|
26.67 score on a scale
Standard Deviation 3.14
|
|
Change in Cognitive Domains as Measured by Montreal Cognitive Assessment
12 months
|
25.88 score on a scale
Standard Deviation 2.68
|
25.58 score on a scale
Standard Deviation 3.15
|
Adverse Events
Arm 1
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=27 participants at risk
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.
|
Arm 2
n=25 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Urinary tract infection
|
3.7%
1/27 • Number of events 1 • 1 year
No difference from clinicaltrials.gov description
|
0.00%
0/25 • 1 year
No difference from clinicaltrials.gov description
|
|
Metabolism and nutrition disorders
Hyponatremia
|
3.7%
1/27 • Number of events 1 • 1 year
No difference from clinicaltrials.gov description
|
0.00%
0/25 • 1 year
No difference from clinicaltrials.gov description
|
|
General disorders
Surgery
|
0.00%
0/27 • 1 year
No difference from clinicaltrials.gov description
|
4.0%
1/25 • Number of events 1 • 1 year
No difference from clinicaltrials.gov description
|
Other adverse events
| Measure |
Arm 1
n=27 participants at risk
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.
|
Arm 2
n=25 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Foot injury
|
0.00%
0/27 • 1 year
No difference from clinicaltrials.gov description
|
4.0%
1/25 • Number of events 1 • 1 year
No difference from clinicaltrials.gov description
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place