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Kick Out Parkinson's Disease 2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03882879
Recruitment Status : Completed
First Posted : March 20, 2019
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 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Behavioral: Karate Classes Behavioral: Pre-Intervention Study Visit Behavioral: Bimonthly Online Survey Behavioral: 6-month Study Visit Behavioral: 12-month Study Visit Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: This is a randomized, single-blinded, study of a novel intervention, namely, non-contact karate, for early to middle stage PD.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Karate Intervention to Change Kinematic Outcomes in Parkinson's Disease. KICK OUT 2: A Phase Two, Randomized Trial of a Karate Intervention
Actual Study Start Date : March 3, 2019
Actual Primary Completion Date : March 27, 2020
Actual Study Completion Date : March 27, 2020


Arm Intervention/treatment
Experimental: Arm 1
Participants in Arm 1 will begin participation in 6 months of karate classes immediately after the pre-intervention study visits.
Behavioral: Karate 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

Behavioral: Pre-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.

Behavioral: Bimonthly 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.

Behavioral: 6-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.

Behavioral: 12-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.

Experimental: Arm 2
Participants in Arm 2 will continue their usual exercise routine for six months followed by karate classes for six months
Behavioral: Karate 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

Behavioral: Pre-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.

Behavioral: Bimonthly 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.

Behavioral: 6-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.

Behavioral: 12-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.




Primary Outcome Measures :
  1. Change in mobility as measured by the Timed Up & Go (TUG) [ Time Frame: 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 Outcome Measures :
  1. Change in overall well-being as measured by the Patient Global Impression of Change Scale (PGIC) [ Time Frame: 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. 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. Changes in depression and in anxiety as measured by the Hospital Anxiety and Depression Scale (HADS) [ Time Frame: 12 months ]
    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-intervention, 6-month, and 12-month study visits will be compared.

  2. Change in quality of life as measured by the Parkinson's Disease Questionnaire- Short Form (PDQ-8) [ Time Frame: 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.

  3. Change in cognitive abilities as measured by the Symbol Digit Modalities Test (SDMT) [ Time Frame: 12 months ]
    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 preintervention, 6-month, and 12-month study visits will be compared.

  4. Change in short-term memory abilities as measured by the Digit Span Test (DST) [ Time Frame: 12 months ]
    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 preintervention, 6-month, and 12-month study visits will be compared.

  5. Change in cognitive domains as measured by Montreal Cognitive Assessment (MoCa) [ Time Frame: 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.

  6. Change in camaraderie measured by Physical Activity Group Environment Questionnaire (PAGEQ) [ Time Frame: 12 months ]
    A measure of group cohesion used in sports psychology. This conceptual model of cohesion is a modified version of the GEQ (Group Environment Questionnaire). PAGEQ is divided into two levels of perceptions: an individual's perspective of a group as a whole (collective) and an individual's attraction to a group (personal). These two levels are further defined by social and task aspects. All these components are categorized into four constructs: Group Integration-Social (GI-S), Group Integration-Task (GI-T), Individual Attractions to the Group-Social (ATG-S), and Individual Attractions to the Group-Task (ATG-T).

  7. Change in Instrumented- Timed Up and Go (i-TUG) [ Time Frame: 12 months ]
    A study team member will follow same procedure as the Timed Up & Go (TUG) described above. For the first trial, subjects will be instructed to walk 3 meters. During the second trial, the distance between the arm chair and a taped line will be increased to 7 meters.

  8. Change in Instrumented- WALK (i-WALK) [ Time Frame: 12 months ]
    A test to examine fatigue over time and that will also allow more accurate calculation of gait variability indices by increasing the number of steps. The subject will walk 25 meters, turn and walk back, and repeat this until 2 minutes has elapsed.

  9. Change in Instrumented- SWAY (i-SWAY) [ Time Frame: 12 months ]
    A test to assess balance and postural sway. Subjects will be asked to stand still with their hands across their chests and their feet positioned a set distance apart (scaled to their height) with a wearable sensor that records movements applied to the lumbar trunk. This sensor will record parameters including mean total sway area, path length, jerk, and sway distance in the mediolateral and anteroposterior directions.



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 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.

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): NCT03882879


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
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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03882879    
Other Study ID Numbers: 18012313-02
First Posted: March 20, 2019    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
martial arts
Parkinson's Disease
non-pharmacologic
randomized trial
camaraderie
depression
anxiety
quality of life
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