Status:
COMPLETED
Aerobic Exercise in Parkinson's Disease
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
University of Iowa
Conditions:
Parkinson's Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE2
PHASE3
Brief Summary
Parkinson's disease (PD) is an incurable brain illness that afflicts more than one million Americans, including many aging Veterans. PD places an unbearable burden on the individual due to progressive...
Detailed Description
Parkinson's disease (PD) culminates in dementia, immobility, and death at a huge societal cost. Even early in the course, motor and cognitive dysfunction impairs instrumental activities of daily livin...
Eligibility Criteria
Inclusion
- Men or women aged 40 and older with the diagnosis of idiopathic PD per UK Brain Bank criteria
- Hoehn-Yahr Stage I-III, on stable dopaminergic treatment regimen for equal or greater than 4 weeks prior to baseline.
- Aerobic Fitness: VO2max below "very good" fitness levels for their age and gender at baseline cyle ergometry.
- To include subjects who have room to improve their aerobic fitness, the investigators will enroll only those subjects whose VO2max is below "very good" fitness level (about 90% of the population) using age and gender based VO2max norms based review of 62 studies where VO2max was measured directly in healthy adult subjects in the USA, Canada and 7 European countries (Reference: Shvartz, E and Reibold, RC. Aerobic fitness norms for males and females aged 6 to 75 years: a review.
- Aviat Space Environ Med. 1990; 61:3-11).
- Cognitive function: No dementia per Movement Disorder Society Level I criteria (Reference: Dubois, B, Burn, D, Goetz, C, et al. Diagnostic procedures for Parkinson's disease dementia: recommendations from the movement disorder society task force. Mov Disord. 2007; 22:2314-2324).
- Current active drivers with a valid driver's license
- Veteran or non-veteran
Exclusion
- Subjects unwilling or unable to give informed consent
- Secondary parkinsonism (e.g., drug induced)
- Parkinson-plus syndromes
- History of brain surgery for PD such as deep brain stimulation
- Corrected visual acuity less than 20/50 (due to effect on driving)
- Contraindications to exercise per ACSM criteria for Exercise Testing and Training (Reference: American College of Sports Medicine. Cardiorespiratory Exercise Prescription. In: Ehrman JK, ed. ACSM's Guidelines for Exercise Testing and Prescription.6th ed. Baltimore: Lippincott Williams \& Wilkins, 2010:448-462).
- No confounding acute or unstable medical, psychiatric, orthopedic condition. Subjects who have hypertension, diabetes mellitus, depression, or other common age related illness will be included if their disease under control with stable treatment regimen for at least 30 days.
- Clinically significant TBI or PTSD
- Presence of other known medical or psychiatric comorbidity that in the investigator's opinion would compromise participation in the study
- Presence of dementia per Movement Disorder Society Level I criteria
- Subjects with clinically significant depression as determined by a Beck Depression Inventory (BDI) score greater than 15 at the screening visit
- History of exposure to typical or atypical antipsychotics or other dopamine blocking agents within 6 months prior to the baseline visit
- Use of investigational drugs within 30 days before screening
- Subjects have to be on a stable regimen of central nervous system acting medications (benzodiazepines, antidepressants, hypnotics) for 30 days prior to the baseline visit
- Contraindication to having a brain MRI
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2024
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT03808675
Start Date
July 1 2019
End Date
September 30 2024
Last Update
October 9 2024
Active Locations (2)
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1
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
2
Iowa City VA Health Care System, Iowa City, IA
Iowa City, Iowa, United States, 52246-2292