Effect of Exercise in Parkinsonism

NCT02598973 | Completed Results

• 1 other identifier: N2012-W
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson's Disease; Drug-induced Parkinsonism

Keywords

Parkinson Disease; exercise

Outcome Measures

Primary Outcomes (1)

• Change in Dopamine Transporter Imaging

  change in semi-quantitative Ioflupane-I123 uptake comparing exercise to no intervention.

  1 year

Secondary Outcomes (1)

• Change in Overall Motor Function

  8 weeks

Study Arms (2)

Exercise

ACTIVE COMPARATOR

aerobic walking

Behavioral: Exercise

No exercise

NO INTERVENTION

normal activity

Interventions

Exercise BEHAVIORAL

Aerobic walking

Exercise

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• University of Pennsylvania: collaborator

Study Sites (1)

Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: James Morley
• Organization: Crescenz VA Medical Center

james.morley@va.gov

215-823-5934

Study Officials

• James F Morley, MD

  Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: November 6, 2015
• Study Start: February 1, 2016
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)