Clinical trial NCT04051151: Move to Improve Physical Activity in Parkinson's Disease
Official title: Move to Improve Physical Activity in Parkinson's Disease: MoTIvatE PD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Apathy
Keywords: Physical Activity
Social Incentives
Behavioral Economics
Goal-Directed Behavior
Motivation
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Effectiveness of gameification intervention to improve physical activity levels
timeFrame: Four weeks
measure: Ability of behavioral phenotyping to predict step goal achievement
timeFrame: Four weeks
measure: Ability of behavioral phenotyping to predict change in activity
timeFrame: Four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania's Parkinson's Disease and Movement Disorder Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Nabila Dahodwala, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levy R, Dubois B. Apathy and the functional anatomy of the prefrontal cortex-basal ganglia circuits. Cereb Cortex. 2006 Jul;16(7):916-28. doi: 10.1093/cercor/bhj043. Epub 2005 Oct 5.
citation: Starkstein SE, Mayberg HS, Preziosi TJ, Andrezejewski P, Leiguarda R, Robinson RG. Reliability, validity, and clinical correlates of apathy in Parkinson's disease. J Neuropsychiatry Clin Neurosci. 1992 Spring;4(2):134-9. doi: 10.1176/jnp.4.2.134.
citation: Pedersen KF, Larsen JP, Alves G, Aarsland D. Prevalence and clinical correlates of apathy in Parkinson's disease: a community-based study. Parkinsonism Relat Disord. 2009 May;15(4):295-9. doi: 10.1016/j.parkreldis.2008.07.006. Epub 2008 Sep 17.
citation: Leiknes I, Tysnes OB, Aarsland D, Larsen JP. Caregiver distress associated with neuropsychiatric problems in patients with early Parkinson's disease: the Norwegian ParkWest study. Acta Neurol Scand. 2010 Dec;122(6):418-24. doi: 10.1111/j.1600-0404.2010.01332.x.