Move to Improve Physical Activity in Parkinson's Disease

NCT ID: NCT04051151

Last Updated: 2024-01-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-26

Study Completion Date

2023-12-01

Brief Summary

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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

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Conditions

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Parkinson Disease Apathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gameification Arm

Participants and partners that have randomized to the gamification group will receive instructions and help in setting up a game.

Group Type EXPERIMENTAL

Gameficiation

Intervention Type BEHAVIORAL

Participants and partners that have randomized to the gamification group will receive instructions and help in setting up a game platform via Way to Health. This game will include wearing a Fit Bit device, setting a daily step goal, and point deductions for failure to meet this step goal throughout the following 4 weeks. Participants will move up or down specified levels each week depending on how many days they met their step goal.

Education Arm

Participants and partners that randomized to the control group will receive standard of care educational resources on the importance of physical activity in Parkinson's patients.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Gameficiation

Participants and partners that have randomized to the gamification group will receive instructions and help in setting up a game platform via Way to Health. This game will include wearing a Fit Bit device, setting a daily step goal, and point deductions for failure to meet this step goal throughout the following 4 weeks. Participants will move up or down specified levels each week depending on how many days they met their step goal.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Nabila Dahodwala, MD

Associate Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nabila Dahodwala, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania's Parkinson's Disease and Movement Disorder Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16207933 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1627973 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18801696 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20175757 (View on PubMed)

Other Identifiers

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MoTIvatEPD

Identifier Type: -

Identifier Source: org_study_id

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