Phase
Condition
Dyskinesias
Dystonias
Tic Disorders
Treatment
MV-PDAE: Moderate Volume Partnered Dance Aerobic Exercise
MV-WALK: Moderate Volume Walking
HV-PDAE: High Volume Partnered Dance Aerobic Exercise
Clinical Study ID
Ages > 40 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participants recruited for this study will be age 40 and older with diagnosis of "definite" PD based upon established criteria (Hughes, Daniel et al. 1992) and determined by a board-certified neurologist with specialty training in movement disorders. Individuals must have presented with asymmetric symptoms that included at least 3 of the cardinal signs of PD (rigidity, bradykinesia, tremor, postural instability), and must show clear symptomatic benefit (e.g., alleviated rigidity, bradykinesia, and tremor) from antiparkinsonian medications, e.g., levodopa (Kempster, Williams et al. 2007). They should be in H&Y stages 2, 2.5 and 3, and receive a Montreal Cognitive Assessment (MoCA) score >17 (Litvan, Goldman et al. 2012). Age 40 is the upper limit for young onset PD. We will not recruit individuals with a history of significant alcohol or drug use, nor habitual users of antipsychotics. We will observe patients while OFF their antiparkinsonian medications to avoid dyskinesia, and medication fluctuations that may impact neurophysiology and motor examination. We have successfully observed patients while OFF in several previous trials. The following inclusion criteria apply:
MoCA score >17
Able to walk with or without an assistive device at least 10 feet
Best corrected/aided acuity better than 20/70 in the better eye
Willingness to be randomized to a treatment group
H&Y stages 2, 2.5 and 3
Show clear symptomatic benefit (e.g., alleviated rigidity, bradykinesia, and tremor)from antiparkinsonian medications
Fluent in English to be able to comprehend and participate; older than 40 years;Diagnosis of definite Parkinson's disease by board certified Movement DisordersNeurologist, using standardized UK Brain Bank criteria
Exclusion
Exclusion Criteria:
Participants recruited for this study will be age 40 and older with diagnosis of "definite" PD based upon established criteria (Hughes, Daniel et al. 1992) and determined by a board-certified neurologist with specialty training in movement disorders. Individuals must have presented with asymmetric symptoms that included at least 3 of the cardinal signs of PD (rigidity, bradykinesia, tremor, postural instability), and must show clear symptomatic benefit (e.g., alleviated rigidity, bradykinesia, and tremor) from antiparkinsonian medications, e.g., levodopa (Kempster, Williams et al. 2007). They should be in H&Y stages 2, 2.5 and 3, and receive a Montreal Cognitive Assessment (MoCA) score >17 (Litvan, Goldman et al. 2012). Age 40 is the upper limit for young onset PD. We will not recruit individuals with a history of significant alcohol or drug use, nor habitual users of antipsychotics. The following exclusion criteria apply:
Untreated Major Depression and major psychiatric illness
History of stroke, or traumatic brain injury
Pure-tone threshold average sensitivity at 0.5, 1.0,and 2.0 kHz exceeds 40 dB
Alcohol abuse and/or use of antipsychotics
Planning to leave the area for >1 month during the study time period.
Taking moderate to high doses of beta-blockers with a resting heart rate below 60beats/min given that exercise intensity is measured through target heart rate.
Severe cardiac disease, including NYHA Class III or IV congestive heart failure,clinically significant aortic stenosis, history of cardiac arrest, use of a cardiacdefibrillator, or uncontrolled angina
Other significant co-morbid disease that would impair ability to participate in theexercise-based intervention, e.g. renal failure on hemodialysis, excessive alcoholuse (>14 drinks per wk)
Study Design
Study Description
Connect with a study center
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia 30033-4004
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.