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Kick Out Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03555695
Recruitment Status : Completed
First Posted : June 13, 2018
Last Update Posted : October 27, 2020
Sponsor:
Information provided by (Responsible Party):
Rush University Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Behavioral: Karate Classes Behavioral: Pre-Intervention Focus Group Behavioral: Post-Intervention Focus Group Not Applicable

Detailed Description:

For 10 weeks, 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.

Before beginning the karate classes, each subject will attend a pre-intervention focus group during which subjects will complete an assessment focused on overall mobility, gait, balance, mood, and quality of life. Subjects will be prompted to share their thoughts on exercise, balance, and mindfulness practices in general and in PD specifically.

Following the 10 weeks of twice-weekly karate classes, subjects will attend a post-intervention assessment and focus group during which the pre-intervention assessments will be repeated and the subject's impressions about the karate classes and their effectiveness will be measured.

Finally, the study team will contact subjects 6 months post-intervention to assess continued engagement in karate or related activities and again, the subject's quality of life and global impression of change.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: This is a non-randomized, open-label, non-blinded, 10-week pilot study of a novel intervention, namely, non-contact karate, for early to middle stage PD.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Karate Intervention to Change Kinematic Outcomes in Parkinson's Disease
Actual Study Start Date : June 18, 2018
Actual Primary Completion Date : September 6, 2018
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Karate Class Participants
Eligible subjects will engage in twice-weekly karate classes for 10 weeks, specifically designed for individuals with early to middle stage PD. Subjects will also complete an in-person pre-intervention focus group and post-intervention focus group, as well as a 6 month post-intervention follow up phone call.
Behavioral: Karate Classes
Eligible subjects will engage in twice-weekly karate classes for 10 weeks, 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.

Behavioral: Pre-Intervention Focus Group
At the pre-intervention focus group, the study logistics will be reviewed, informed consent process will occur, the subject will complete a brief, individual pre-intervention assessment focused on overall mobility, gait, balance, mood, neurological status, and quality of life, and the subjects will be prompted to share aloud their thoughts on exercise, balance, and mindfulness practices in general and in PD specifically, and any expectations or preconceptions that they have regarding karate classes for PD.

Behavioral: Post-Intervention Focus Group
At the post-intervention focus group, the pre-intervention assessments 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.




Primary Outcome Measures :
  1. Change in mobility as measured by the Timed Up & Go (TUG) [ Time Frame: 10 weeks ]
    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 Outcome Measures :
  1. Change in overall well-being as measured by the Patient Global Impression of Change Scale (PGIC) [ Time Frame: 10 weeks ]
    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.


Other Outcome Measures:
  1. Change in balance abilities as measured by the Functional Reach Test (FRT) [ Time Frame: 10 weeks ]
    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.

  2. Change in balance abilities as measured by the Tinetti Mobility Test (TMT) [ Time Frame: 10 weeks ]
    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

  3. Change in anxiety as measured by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 10 weeks ]
    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.

  4. Change in cognitive abilities as measured by the Symbol Digit Modalities Test (SDMT) [ Time Frame: 10 weeks ]
    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.

  5. Change in short-term memory abilities as measured by the Digit Span Test (DST) [ Time Frame: 10 weeks ]
    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.

  6. Sustainability of an exercise program in patients with PD [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555695


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Investigators
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Principal Investigator: Jori Fleisher, MD Rush University Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03555695    
Other Study ID Numbers: 18012313
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rush University Medical Center:
karate
exercise
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases