Developing Personalized Medicine Strategies to Increase Physical Activity in Parkinson's Disease (PD) Through Digital Health Technology

NCT05529121 | Completed

• 1 other identifier: 1616612
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

Under a grant from the Department of Defense's PD program, Dr. Morley's is investigating new approaches that 1) use "gamification"- applying rules of games like point scoring, achieving silver, gold or platinum levels and competition-- to increase physical activity in PD; 2) identify whether certain PD patient respond differently to gamification interventions than others.; 3) use readily and commercially available (including Fitbits) digital health technologies to perform all study activities remotely and enable a "touchless" study where patients don't have to come in person for any studies visits. The study is underway and actively recruiting.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; Exercise; Economics, Behavioral

Outcome Measures

Primary Outcomes (3)

• Determine the feasibility and acceptability of a "touchless" intervention to increase physical activity in patients with PD using digital health technology and behavioral economics strategies

  Protocols using gamification to increase physical activity in patients with PD employing remote intervention and assessment will be feasible and acceptable to participants. Specifically we hypothesize that subjects will: H1a) wear their activity monitor ≥ 80% of the time; H1b) successfully create a remote monitoring account and sync their device; H1c) wear and capture motor symptoms with the PKG and H1d) report high program acceptability (Intrinsic Motivation Inventory score ≥ 5)

  2026

• Determine whether non-motor features predict responsiveness to a behavioral economic-based gamification intervention to increase physical activity in patients with PD

  Non-motor and features, in particular risk aversion as measured by the DOSPERT scale, will be associated with change in daily step count during the gamification intervention

  2026

• Determine whether changes in physical activity in response to a gamification intervention impact PD motor symptoms measured using a remotely-monitored wearable device

  Increased activity during the gamification intervention will be associated with improvement of motor scores remotely measured using the Parkinson's Kineticgraph (PKG)

  2026

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Veteran participants within the VISN4 region (a network of 9 VA medical centers and 45 outpatient clinics, covering Pennsylvania, Delaware and parts of Ohio, West Virginia, New York and New Jersey).

You may qualify if:

• Have a clinical diagnosis of PD.
• Are on a stable regimen of anti-parkinsonian medication that have not changed since the prior visit.
• Have not fallen more than once within the past year.
• To the greatest extent possible, seek to include and study Veterans with deployment, environmental, or occupational exposures as risk factors for Parkinson's disease. These will include neurotoxins (Agent Orange, Camp Lejune groundwater, Southwest Asia burn pits) and Traumatic Brain Injury, as these exposures are commonly encountered in our Veteran population and are of significant interest as risk factors for PD.

You may not qualify if:

• Diagnosis of an atypical parkinsonian syndrome or concomitant administration of a drug that could cause parkinsonian syndromes.
• Cardiovascular or other medical comorbidities that preclude participation in an intervention to increase physical activity
• Lack of access to a smartphone or other device (tablet or networked computer) that can be used to interface with the Fitbit app and Way to Health platform
• PD Hoehn/Yahr stage \>2.5 indicating significant balance or functional impairment that would preclude participation in an intervention to increase physical activity
• Clinical diagnosis of dementia
• Active impulse control disorder

Sponsors & Collaborators

• Corporal Michael J. Crescenz VA Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

Corporal Michael J. Crescenz VA Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Motor Activity; Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

• James Morley

  Corporal Michael J. Crescenz VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-director, Parkinson's Disease Research, Education and Clinical Center, Crescenz VAMC

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: December 3, 2021
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)