Kick Out Parkinson's Disease 2

NCT03882879 | Completed Results

• 1 other identifier: 18012313-02
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

karate; exercise; martial arts; Parkinson's Disease; non-pharmacologic; randomized trial; camaraderie; depression; anxiety; quality of life

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC)

  12 months

Other Outcomes (3)

• Changes in Depression as Measured by the Hospital Anxiety and Depression Scale

  12 months

• Change in Quality of Life as Measured by the Parkinson's Disease Questionnaire- Short Form (PDQ-8)

  12 months

• Change in Cognitive Domains as Measured by Montreal Cognitive Assessment

  12 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Participants in Arm 1 will begin participation in 6 months of karate classes immediately after the pre-intervention study visits.

Behavioral: Karate Classes; Behavioral: Pre-Intervention Study Visit; Behavioral: Bimonthly Online Survey; Behavioral: 6-month Study Visit; Behavioral: 12-month Study Visit

Arm 2

EXPERIMENTAL

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

Behavioral: Karate Classes; Behavioral: Pre-Intervention Study Visit; Behavioral: Bimonthly Online Survey; Behavioral: 6-month Study Visit; Behavioral: 12-month Study Visit

Interventions

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

Arm 1; Arm 2

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.

Arm 1; Arm 2

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.

Arm 1; Arm 2

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.

Arm 1; Arm 2

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.

Arm 1; Arm 2

Eligibility Criteria

• Age: 30 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (2)

• 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.

  PMID: 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. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Motor Activity; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior; Behavioral Symptoms; Mental Disorders

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Jori Fleisher
• Organization: Rush University Medical Center

jori_fleisher@rush.edu

13125632900

Study Officials

• Jori Fleisher, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, single-blinded, study of a novel intervention, namely, non-contact karate, for early to middle stage PD.

Study Record Dates

• First Submitted: March 19, 2019
• First Posted: March 20, 2019
• Study Start: March 3, 2019
• Primary Completion: March 27, 2020
• Study Completion: March 27, 2020
• Last Updated: April 12, 2024
• Results First Posted: April 12, 2024

Record last verified: 2023-10

Locations

US (1)