Moderate Versus High Volume Light-Moderate Intensity Exercise for People With Moderate Parkinson's Disease (HI-LITE)
Parkinson Disease, Movement Disorders, Neurodegeneration
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring dance, walk, Neurodegenerative, aging, exercise, high volume, frequency, intensity, duration, biomarkers, Parkinson's disease
Eligibility Criteria
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 Disorders Neurologist, using standardized UK Brain Bank criteria 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 60 beats/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 cardiac defibrillator, or uncontrolled angina Other significant co-morbid disease that would impair ability to participate in the exercise-based intervention, e.g. renal failure on hemodialysis, excessive alcohol use (>14 drinks per wk)
Sites / Locations
- Atlanta VA Medical and Rehab Center, Decatur, GA
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
HV-PDAE: High Volume Partnered Dance Aerobic Exercise
MV-PDAE: Moderate Volume Partnered Dance Aerobic Exercise
MV-WALK: Moderate Volume Walking
HV-PDAE classes will meet 5 times a week for 90 minute sessions for 3 weeks at onset of trial and then every 4 weeks for a year. All participants will receive 112.5h of training. PDAE was adapted for older adults with balance impairments; modifications were made to the frame and steps of Argentine tango. People with PD partner an individual without PD, e.g., staff, caregiver, friend, or university student. The instructor, staff lead and assistants monitor participants for safety. Class sizes will consist of 6 or fewer pairs of participants with PD and partners. Participants with PD will dance with new partners (individuals without PD) every 15-20 minutes. Participants will learn new steps in each class. The class format includes practicing steps, warm-up, partnering and rhythmic exercises, learning new steps, combining old and new steps, cool down. PDAE classes follow a syllabus with new steps, rhythms and embellishments included in each class.
MV-PDAE: MV classes will meet biweekly for 52 weeks for 65-minute sessions. All participants will receive 112.5h of training. . PDAE was adapted for older adults with balance impairments; modifications were made to the frame and steps of Argentine tango. People with PD partner an individual without PD, e.g., staff, caregiver, friend, or university student. The instructor, staff lead and assistants monitor participants for safety. Class sizes will consist of 6 or fewer pairs of participants with PD and partners. Participants with PD will dance with new partners (individuals without PD) every 15-20 minutes. Participants will learn new steps in each class. The class format includes practicing steps, warm-up, partnering and rhythmic exercises, learning new steps, combining old and new steps, cool down. PDAE classes follow a syllabus with new steps, rhythms and embellishments included in each class.
MV-WALK (65-minute sessions): WALK will control for the walking that participants in PDAE do and will also take place in groups to control social effects of intervention. Walking for exercise expends 3 METS, like PDAE. (Knaggs et al., 2011) 65 minute sessions will consist of 15 minutes of warmup exercises, 45 minutes of walking with breaks ad libitum, and a 5-minute cool down. Setting will be a designated, safe, non-cluttered area for walking- indoors or outdoors. This protocol is in line with recommendations for gait training to improve gait parameters, i.e., 2-3 days per week, for 30-60 minutes and with evidence that light-moderate intensity walking programs can lead to gains in gait parameters.