N/A N=9 Randomized Single-blind Other

Effect of Exercise in Parkinsonism

Parkinson's Disease · Drug-induced Parkinsonism

Bottom Line

View on ClinicalTrials.gov: NCT02598973 ↗

Enrolled (actual)

Serious AEs

11.1%

Results posted

Oct 2024

Primary outcome: Primary: Change in Dopamine Transporter Imaging — 4.6; -15.9 % change in arbitrary intensity units

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Exercise (Behavioral)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: VA Office of Research and Development
Primary completion: Jan 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Dopamine Transporter Imaging	4.6; -15.9	—
SECONDARY Change in Overall Motor Function	-2.3; 10.5	—

Summary

Parkinson's disease (PD) is a common neurodegenerative disorder affecting approximately 80,000 Veterans, representing a priority area for VA research. Current medicines for PD only improve symptoms, treatments that slow disease progression are needed, and earlier diagnosis of PD may be the key to their development. PD symptoms can be mimicked by medicines (most commonly antipsychotic drugs that block dopamine), and some of these patients actually have underlying "prodromal" PD that was "unmasked" years before it would have caused symptoms. This problem is increasing as these medicines are now used for common conditions including post-traumatic stress disorder and depression. The investigators will identify prodromal PD in patients with drug-induced symptoms using brain scans. These patients will be enrolled in a randomized clinical trial of aerobic exercise which slows progression in animal models of PD and has other health benefits. The investigators will measure the effect of exercise on symptoms, disease progression (using brain scans) and markers of PD risk (using blood tests). These studies will improve early PD diagnosis and potentially identify a way to slow progression of PD.

Eligibility Criteria

Inclusion Criteria

Veteran
Subjects with parkinsonian signs:
rest tremor
rigidity
bradykinesia
Parkinsonian signs occurring after the institution of therapy with a medication having a known association with DIP, examples include:
haloperidol
chlorpromazine
fluphenazine
perphenazine
risperidone
thioridazine
thiothixene
lithium
valproic acid
ziprasidone
olanzapine
aripiprazole
Potential subjects with DIP will be pre-screened using a brief (12 item) scratch and sniff smell test with hyposmic subjects invited to learn more about the study.
clinical diagnosis of H/Y <=2 PD

Exclusion Criteria

Subjects with a known diagnosis of atypical parkinsonian syndrome, i.e.:
dementia with Lewy bodies
progressive supranuclear palsy
corticobasal degeneration
multiple system atrophy)
or other neurodegenerative condition
Subjects with a history of:
sinus trauma or surgery
encephalitis
current nasal congestion or other known reason for olfactory impairment
Subjects with a contraindication to DaTI (sensitivity or allergy to iodine, treatment with a drug with a significant effect on DaTscan that cannot be temporarily weaned)
Subjects with known unstable cardiac, pulmonary, orthopedic or other conditions that would preclude safe participation in exercise training
Subjects currently engaging in exercise more than 45 minutes per day, 3 days per week

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02598973). 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.