N/A
N=57
Aerobic Exercise in Parkinson's Disease
Parkinson's Disease
Bottom Line
View on ClinicalTrials.gov: NCT03808675 ↗Enrolled (actual)
57
Serious AEs
10.5%
Results posted
Mar 2026
Primary outcome: Primary: Change in MDS-UPDRS Part III Motor (OFF) Score — 0.44; -2.96 score on scale — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aerobic walking (Behavioral); Usual care with PD specific health education (Behavioral)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in MDS-UPDRS Part III Motor (OFF) Score |
0.44; -2.96 | >0.05 |
| PRIMARY Change in Flanker Task |
-1.0; 3.6 | >0.05 |
| PRIMARY Change in Road Safety Error Count |
-2.5; -3.9 | >0.05 |
| PRIMARY Change in the Parkinson's Disease Questionnaire-39 (PDQ-39) Score |
1.04; -0.11 | >0.05 |
| PRIMARY Change in Cingulum Cingulate Radial Diffusivity (rD) |
-2.23; -1.16 | >0.05 |
| PRIMARY Change in Superior Longitudinal Fasciculus Radial Diffusivity (rD) |
0.12; 0.09 | >0.05 |
| PRIMARY Change in Putamen Radial Diffusivity |
-0.03; -1.01 | >0.05 |
| SECONDARY Change in MDS-UPDRS Non-motor Experiences of Daily Living Subscale (Part I) Score |
0.15; 0.41 | >0.05 |
| SECONDARY Change in MDS-UPDRS Motor Experiences of Daily Living Score (Part II) |
1.15; -0.04 | >0.05 |
| SECONDARY Change in ON Period MDS-UPDRS Motor Examination Subscale Score (Part 3) |
-1.88; -1.41 | >0.05 |
| SECONDARY Change in MDS-UPDRS Dyskinesia and Motor Fluctuations (Part 4) |
0.58; 0.67 | >0.05 |
| SECONDARY Change in Total MDS-UPDRS Score |
-1.77; -1.04 | >0.05 |
| SECONDARY Change in 2-Minute Walk Test |
16.0; 19.0 | >0.05 |
| SECONDARY Change in 9-Hole Peg Board Test (OFF) |
-0.47; 1.24 | >0.05 |
| SECONDARY Change in 9-Hole Peg Board Test of NIH Toolbox Motor Battery (ON) |
-0.51; 0.88 | >0.05 |
| SECONDARY Change in Montreal Cognitive Assessment (MOCA) |
-0.42; 0.19 | >0.05 |
| SECONDARY Change in COGSTAT Score |
7.1; 11.4 | >0.05 |
| SECONDARY Change in Controlled Oral Word Association Task (COWA) |
0.96; 3.33 | >0.05 |
| SECONDARY Change in Block Design Test (BLOCKS) |
0.62; 0.00 | >0.05 |
| SECONDARY Change in Judgment of Line Orientation Test (JLO) |
0.44; 0.74 | >0.05 |
| SECONDARY Change in Delayed Recall of Rey Auditory Verbal Learning Test (AVLT-Recall) |
0.00; 0.08 | >0.05 |
| SECONDARY Change in Complex Figure Test -Copy (CFT-Copy) |
1.31; 1.09 | >0.05 |
| SECONDARY Change in Complex Figure Test-Recall (CFT-Recall) |
0.87; 0.06 | >0.05 |
| SECONDARY Change in Benton Visual Retention Test (BVRT) |
-0.77; -0.04 | >0.05 |
| SECONDARY Change in Trail Making Test- A (TMT-A) |
-5.3; -2.5 | >0.05 |
| SECONDARY Change in Trail Making Test - B (TMT-B) |
-2.4; 0.7 | >0.05 |
| SECONDARY Trail Making Test B-A (TMT B-A) |
2.9; 3.2 | >0.05 |
| SECONDARY Change of Geriatric Depression Scale (GDS) Score |
0.00; 0.04 | >0.05 |
| SECONDARY Change in Beck Anxiety Inventory (BAI) Score |
-0.15; 0.93 | >0.05 |
| SECONDARY Change in Fatigue Severity Scale (FSS) |
-0.12; 1.37 | >0.05 |
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT03808675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.