Move to Improve Physical Activity in Parkinson's Disease

Not Applicable

Completed

• Conditions: Parkinson Disease; Apathy
• Interventions: Behavioral: Gameficiation

• Registration Number: NCT04051151
• Lead Sponsor: University of Pennsylvania

Brief Summary

Apathy is a multi-dimensional behavior characterized by impairments to motivation, planning and initiation; collectively called, goal-directed behavior. It is highly prevalent in patients suffering from neurological disorders such as Alzheimer's disease and Parkinson's disease (PD) as well as psychiatric disorders such as depression and schizophrenia. In PD, specifically, apathy is one of the more troublesome symptoms. Apathetic PD patients have greater disability, lower adherence to treatment plans and caregivers report greater stress and burden.

Interventions grounded in behavioral economic theories, namely, financial and social incentives often promote positive behavioral change such as weight loss and smoking cessation. However, the effectiveness of these interventions varies across and within conditions and incentive type. It also tends to dissipate when incentives are no longer provided. To date, these approaches have not been used to promote behavior change in PD or other neurological conditions where apathetic behaviors are a pressing problem. The overall goal of this study is to test if behavioral economic approaches will reduce apathy, and subsequently, improve goal-directed behavior in Parkinson's disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-26
• Study First Submitted QC: 2019-08-06
• Study First Posted: 2019-08-09
• Study Start: 2019-08-26
• Primary Completion: 2020-01-01
• Study Completion: 2023-12-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Eligible participants will have a diagnosis of Parkinson's disease, and may have either normal cognition or mild cognitive impairment (MCI). Most eligible participants will have to have smartphones with wifi, application, Bluetooth, and text messaging capabilities. The study team does have five smart phone that can be provided to participants who do not have smartphones so as to not exclude these individuals.
• Eligible participants will have to be mobile as the primary outcome measure for the study is step goals measured on the Fitbit. Participants will be eligible if they can ambulate successfully with a cane.
• Participants will also need a study partner to be eligible to participant. This partner can be anyone of the eligible participant's choosing, who also consents to participation in the study.

Exclusion Criteria

• Individuals will be excluded if they screen positive for dementia at the screening visit or do not have the decisional capacity to give consent. Dementia will be defined as a Montreal Cognitive Assessment (MoCA) score of <22. Decisional capacity will be tested based on their understanding of study risks and benefits.
• Individuals will also be excluded if they require a wheelchair or walker, or are unable to ambulate safely.
• Individuals will be excluded if they are currently participating in another physical activity study, have been told by a physician not to exercise, or are currently pregnant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gameification Arm	Gameficiation	Participants and partners that have randomized to the gamification group will receive instructions and help in setting up a game.

Primary Outcome Measures

Name	Time	Method
Ability of behavioral phenotyping to predict step goal achievement	Four weeks	Among participants in the intervention group, the researchers will compare the number of days that step goals were achieved between individuals with greater motivation deficits and those with initiation and planning deficits using a one-way independent ANOVA.
Effectiveness of gameification intervention to improve physical activity levels	Four weeks	To test the feasibility and preliminary effectiveness of a gamification intervention that enhances supportive social incentives that includes collaboration, accountability and peer support to improve physical activity levels compared to a control group that receives the standard of care. The researchers will compare the change in mean daily steps between the gameification and control (education) groups using an independent t-test.
Ability of behavioral phenotyping to predict change in activity	Four weeks	Among participants in the intervention group, the researchers will compare the change in mean daily steps between individuals with greater motivation deficits and those with initiation and planning deficits using a one-way independent ANOVA.

Trial Locations

Locations (1)

University of Pennsylvania's Parkinson's Disease and Movement Disorder Center; 🇺🇸 Philadelphia, Pennsylvania, United States