Aerobic Exercise in Parkinson's Disease (NCT03808675) | Clinical Trial Compass
CompletedNot Applicable
Aerobic Exercise in Parkinson's Disease
United States57 participantsStarted 2019-07-01
Plain-language 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 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.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in MDS-UPDRS Part III Motor (OFF) Score
Timeframe: Final Visit at 1 year - Baseline
2
Change in Flanker Task
Timeframe: Final visit at 1 year - Baseline
3
Change in Road Safety Error Count
Timeframe: Final Visit at 1 year - Baseline
4
Change in the Parkinson's Disease Questionnaire-39 (PDQ-39) Score
Timeframe: Final Visit at 1 year - Baseline
5
Change in Cingulum Cingulate Radial Diffusivity (rD)
Timeframe: Final Visit at 1 year - Baseline
6
Change in Superior Longitudinal Fasciculus Radial Diffusivity (rD)