Aerobic Exercise in Parkinson's Disease

Completed · Not applicable

Conditions studied: Parkinson's Disease

In brief

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 impairment of movement and mental function. As a result, patients lose critical abilities such as driving and can become isolated. Although drugs and surgery help movement problems, their benefits are temporary and may cause side effects. Drugs provide limited and temporary benefit for cognition and do not prevent dementia. Animal and preliminary human studies on aerobic exercise show promising results in helping a broad spectrum of symptoms. However, due to limited and inconsistent research results, the long term effects of aerobic exercise on brain health and clinical features in PD is unknown. The investigators will conduct a clinical trial to test the long term effects of aerobic exercise on the brain tissue, movement, mental functions, and driving in PD. If effective, aerobic exercise can be implemented immediately as a low cost, easily accessible treatment in PD.

Key facts

Study ID: NCT03808675
Run by: VA Office of Research and Development
People needed: 57
Starts: 2019-07-01
Expected to finish: 2024-09-30
Last updated by the study team: 2026-03-12

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
Iowa City VA Health Care System, Iowa City, IA — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.