Comparing different exercise volumes for veterans with moderate Parkinson's disease
Moderate Versus High Volume Light-Moderate Intensity Exercise for People With Moderate Parkinson's Disease
This study is testing whether veterans with moderate Parkinson's disease benefit more from high-volume dance exercise or moderate-volume walking to improve their physical activity and walking speed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 123 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Decatur, Georgia) |
| Trial ID | NCT06088355 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of high volume versus moderate volume light-moderate intensity exercise on veterans with moderate Parkinson's disease. Participants will engage in either high volume partnered dance aerobic exercise or moderate volume walking, with the aim of determining which approach is more effective in improving physical activity, gait measures, and biomarkers of neurodegeneration. The study will assess participants' walking speed, physical activity levels, and vascular stiffness before and after the exercise interventions. This research is significant as it explores the optimal delivery of exercise for individuals with moderate Parkinson's disease, a population that has not been extensively studied in this context.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans aged 40 and older diagnosed with moderate Parkinson's disease who exhibit clear symptomatic benefits from antiparkinsonian medications.
Not a fit: Patients with severe Parkinson's disease symptoms or those with a history of significant substance abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved exercise recommendations that enhance physical function and quality of life for patients with moderate Parkinson's disease.
How similar studies have performed: While studies have explored high intensity exercise in Parkinson's disease, this investigation into exercise volume is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Decatur, Georgia
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States (Recruiting)
Study contacts
- Principal investigator: Madeleine E. Hackney, PhD — Atlanta VA Medical and Rehab Center, Decatur, GA
- Study coordinator: Madeleine E Hackney, PhD
- Email: mehackn@emory.edu
- Phone: (404) 321-6111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.