Parkinson Disease Clinical Trial
Official title:
Karate Intervention to Change Kinematic Outcomes in Parkinson's Disease
NCT number | NCT03555695 |
Other study ID # | 18012313 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 18, 2018 |
Est. completion date | March 31, 2019 |
Verified date | October 2023 |
Source | Rush University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The benefits of exercise for general health and wellbeing 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. Noncontact 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. However, drawing on this experience and the combined aerobic, balance, and mindfulness practices that comprise karate, we hypothesize that participation in structured karate programs may offer similar or greater benefits. Specifically, 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; and 2) improves objective and patient-reported outcomes.
Status | Completed |
Enrollment | 19 |
Est. completion date | March 31, 2019 |
Est. primary completion date | September 6, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 90 Years |
Eligibility | Inclusion Criteria: - Subjects will be those diagnosed with Parkinson's Disease by a treating neurologist; 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 neurologist sign a form confirming the diagnosis of Parkinson's Disease and indicating the subject's HY stage (with definitions of each stage provided on the form for providers who may not be familiar with HY staging) at the most recent visit, to be sent back to the study 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 10-week study, however if emergent issues arise requiring medication changes, the subject will not be disqualified. 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 10 weeks. - 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 neurologist. |
Country | Name | City | State |
---|---|---|---|
United States | Rush University Medical Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Rush University Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Balance Abilities as Measured by the Functional Reach Test (FRT) | The Functional Reach Test (FRT) is a brief, valid, reliable, and practical assessment of balance. This test involves a yardstick being mounted on a wall at shoulder height. The subject is asked to stand next to the yardstick, extend the arm closest to the wall at 90 degrees of shoulder flexion, and the distance is recorded. The subject is then asked to reach as far as he or she can forward without taking a step, and the distance is recorded again. The difference between start and end position is the reach distance. Greater reach distances indicate better balance. Scores at the pre- and post-intervention focus groups will be compared. | 10 weeks | |
Other | Change in Balance Abilities as Measured by the Tinetti Mobility Test (TMT) | The Tinetti Mobility Test (TMT) consists of 2 subscales: balance tests (9 items, scored from 0-16) and gait tests (7 items, scored from 0-12), where higher scores reflect better performance. Scores at the pre- and post-intervention focus groups will be compared | 10 weeks | |
Other | Change in Anxiety as Measured by the Hospital Anxiety and Depression Scale (HADS) | The Hospital Anxiety and Depression Scale (HADS) is a brief, 14-item highly validated scale for measuring anxiety (7 items) and depression (7 items), where scores of >8 for either anxiety or depression indicate probable symptoms. Scores at the pre- and post-intervention focus groups will be compared. | 10 weeks | |
Other | Change in Cognitive Abilities as Measured by the Symbol Digit Modalities Test (SDMT) | In the Symbol Digit Modalities Test (SDMT), the subject uses a reference key to pair specific numbers with given abstract geometric figures in 90 seconds. Scores are the correct number of pairs made in 90 seconds, with greater scores indicating greater cognitive abilities. Scores at the pre-and post-intervention focus groups will be compared. | 10 weeks | |
Other | Change in Short-term Memory Abilities as Measured by the Digit Span Test (DST) | The Digit Span Test (DST) tests the number of digits a subject can recall in the correct order after hearing them. The experimenter says numbers slowly at one second intervals. Subjects are asked to repeat the numbers in the order they were given. A subject's digit span is the number of items they are able to report back in order correctly. Scores at the pre-and post-intervention focus groups will be compared. | 10 weeks | |
Other | Number of Participants Continuing to Attend Karate Classes | During the six month follow-up phone call, subjects will be asked whether they have continued to participate in any structured karate or martial arts classes. If yes, frequency and location of these classes will be asked. If no, reasons for lack of participation will be asked. Larger numbers of "yes" responses would indicate program sustainability. | 6 months | |
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. | 10 weeks | |
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. Percentages of subjects endorsing each of the 7 response options will be compared. This scale will be completed at the post-intervention focus group. | 10 weeks | |
Secondary | Quality of Life - Parkinson's Disease Questionnaire Short Form (PDQ-8) | Validated 8-item PD-specific health-related quality of life measure; lower scores (score range 0-100) indicate better quality of life | 10 weeks | |
Secondary | Attendance at Twice Weekly Classes | Attendance at twice weekly classes, measured by karate instructors | Ten weeks | |
Secondary | "Would You Recommend Karate Classes to Another Individual With Parkinson's Disease?" | Number of individuals answering "Yes" | Ten weeks |
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