Last reviewed · How we verify

NCT03882879

Kick Out Parkinson's Disease 2

Completed NA Results posted Last updated 12 April 2024
What this trial tests

NA trial testing Karate Classes in Parkinson Disease in 52 participants. Completed in 27 March 2020.

Timeline
3 March 2019
Primary endpoint
27 March 2020
27 March 2020

Quick facts

Lead sponsorRush University Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingdouble
Primary purposeprevention
Enrollment52
Start date3 March 2019
Primary completion27 March 2020
Estimated completion27 March 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Rush University Medical Center

Who can join

Adults 30 to 90, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Mobility as Measured by the Timed Up & Go (TUG) Primary · 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.

Baseline
GroupValue95% CI
Arm 19.66± 1.62
Arm 29.19± 1.56
12-month
GroupValue95% CI
Arm 110.9± 1.67
Arm 210.03± 2.2
Change in Overall Well-being as Measured by the Patient Global Impression of Change Scale (PGIC) Secondary · 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.

GroupValue95% CI
Arm 15.47± 1.18
Arm 25.75± 1.14
Changes in Depression as Measured by the Hospital Anxiety and Depression Scale Secondary · 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.

Baseline
GroupValue95% CI
Arm 14.53± 3.18
Arm 24.08± 3.23
12 months
GroupValue95% CI
Arm 13.59± 2.62
Arm 22.92± 2.94
Change in Quality of Life as Measured by the Parkinson's Disease Questionnaire- Short Form (PDQ-8) Secondary · 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.

Baseline
GroupValue95% CI
Arm 125.22± 16.73
Arm 229.25± 20.34
12-month
GroupValue95% CI
Arm 120.67± 13.66
Arm 221± 17.58
Change in Cognitive Domains as Measured by Montreal Cognitive Assessment Secondary · 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.

Baseline
GroupValue95% CI
Arm 125.88± 2.66
Arm 226.67± 3.14
12 months
GroupValue95% CI
Arm 125.88± 2.68
Arm 225.58± 3.15

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm 1
Serious: 2/27 (7%)
Deaths: 0/27
Arm 2
Serious: 1/25 (4%)
Deaths: 0/25

Serious adverse events (3 terms)

ReactionSystemArm 1Arm 2
Urinary tract infectionInfections and infestations
HyponatremiaMetabolism and nutrition disorders
SurgeryGeneral disorders
Other adverse events (1 terms — click to expand)

ReactionSystemArm 1Arm 2
Foot injuryMusculoskeletal and connective tissue disorders

Most-reported serious reactions: Urinary tract infection, Hyponatremia, Surgery.

Data from ClinicalTrials.gov NCT03882879 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis.
    Ernst M, Folkerts AK, Gollan R, Lieker E, et al · · 2023 · cited 110× · PMID 36602886 · DOI 10.1002/14651858.cd013856.pub2
  2. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis.
    Ernst M, Folkerts AK, Gollan R, Lieker E, et al · · 2024 · cited 37× · PMID 38588457 · DOI 10.1002/14651858.cd013856.pub3
  3. Synaptic Plasticity in Neurodegenerative Diseases: Impact of Exercise as Promising Therapeutic Tool.
    Farina G, Fenili G, Paronetto MP, Crescioli C. · · 2026 · PMID 41597271 · DOI 10.3390/cells15020197

Verify or expand the search:

Other trials of Karate Classes

Trials testing the same drug.

Other recruiting trials for Parkinson Disease

Currently open trials in the same condition.

Other Rush University Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03882879.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing