Gamification and Physical Activity in PD

NCT07286994 | Not Yet Recruiting

• 1 other identifier: NURM-003-25S
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Despite overwhelming evidence that exercise can improve motor and non-motor symptoms of Parkinson's Disease (PD), less than 25% of Veterans with PD meet recommended activity goals. Interventions to increase PA that are scalable and can be deployed in the community represent a major opportunity. The investigators' preliminary work has demonstrated that gamification, a method commonly used for health promotion, can lead to increases in physical activity in PD. In this study, the investigators will test the effectiveness of gamification in a randomized trial to increase activity. Importantly, the investigators will also examine the effect of step count and exercise intensity on clinical outcomes and explore factors important to widespread implementation of the program VA.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Exercise; Economics, Behavioral

Outcome Measures

Primary Outcomes (3)

• Change in step counts

  Primary outcome: change in daily step counts from baseline to intervention. H1a: subjects randomized to gamification will increase step counts significantly more than controls.

  end of intervention period (week 26)

• Bradykinesia

  Primary outcome: association between changes in step count and changes in bradykinesia. Bradykinesia scores are measured during the last week of the study period using the wrist-worn PKG by Empatica device. Bradykinesia scores are numeric, with higher numbers indicating more severe symptoms.

  end of intervention period (week 26)

• Non-motor symptoms questionnaire (NMSQ)

  Association between changes in step count and changes in NMSQ during the intervention. The NMSQ is a well-validated 30-item questionnaire assessing the severity of non-motor symptoms in PD. Questions are subdivided into various non-motor domains (cardiovascular, sleep, mood, hallucinations, memory, GI, urinary, sexual function, and miscellaneous). Higher scores indicate more severe symptoms.

  end of intervention period (week 26)

Secondary Outcomes (1)

• Change in Moderate/Vigorous Physical Activity (MVPA)

  end of intervention period (week 26)

Study Arms (2)

Gamification

EXPERIMENTAL

Subjects will participate in an automated gamification intervention with loss or gain of points based on reaching a step goal target

Behavioral: Gamification

Feedback control

ACTIVE COMPARATOR

Subjects in the control group will only receive a daily text message reminding them of their daily step goal and whether they met the goal or not

Behavioral: Feedback control

Interventions

Gamification BEHAVIORAL

Subjects will participate in an automated gamification intervention with loss or gain of points based on reaching a step goal target

Gamification

Feedback control BEHAVIORAL

Subjects in the control group will only receive a daily text message reminding them of their daily step goal and whether they met the goal or not

Feedback control

Eligibility Criteria

• Age: 50 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veterans
• Have a clinical diagnosis of PD based on diagnosis codes and chart review
• Are on a stable regimen of anti-parkinsonian medication

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
• Fallen more than twice within the past year (assessed via phone screening)
• Clinical diagnosis of dementia

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Philadelphia, Pennsylvania, 19104-4551, 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 F Morley, MD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James F Morley, MD

CONTACT

(215) 823-5800; James.Morley@va.gov

Scott R Greysen, MD

CONTACT

(215) 823-5800; scott.greysen@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized 1:1 to either a gamification intervention or control arm

Study Record Dates

• First Submitted: December 3, 2025
• First Posted: December 16, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2030
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)