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Parkinson DiseaseNCT07286994

Gamification and Physical Activity in PD

A study testing Gamification in people with Parkinson Disease, run by VA Office of Research and Development at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 89 years
Conditions the study is for
Parkinson Disease
What is being tested?
Gamification
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited States
Study dates
1 Oct 2026to 30 Sep 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Veterans
  • Have a clinical diagnosis of Parkinson's Disease (PD) based on diagnosis codes and chart review
  • Are on a stable regimen of anti-parkinsonian medication

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

James F Morley, MD PhD contact

(215) 823-5800 ext. 3285

James.Morley@va.gov

Scott R Greysen, MD contact

(215) 823-5800

scott.greysen@va.gov

United States1 site
  • Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA

    Philadelphia, Pennsylvania, 19104-4551

    James F Morley, MD PhD, (215) 823-5800 ext. 3285, James.Morley@va.gov

    James F Morley, MD PhD

Other trials in United States

About this study

Official title: Randomized-controlled Trial of Remotely-deployed Gamification Interventions to Increase Physical Activity in Veterans With Parkinsons Disease

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.

Read the detailed description

Background/Significance: Exercise and physical activity (PA) improve PD symptoms and have been hypothesized to modify disease onset and progression. Further, exercise has been shown to improve debilitating non-motor symptoms (NMS, including depression, sleep, cognition) that are unresponsive or even worsened by dopaminergic treatments used to improve motor symptoms. Most of this evidence comes from resource-intensive, short-term observed trials of exercise, while the investigators' work and that of others has demonstrated low free-living activity levels in PD that worsen with disease duration. In fact, less than 25% of Veterans meet recommended activity goals. Interventions to increase PA that are scalable and can be deployed in the community represent a major opportunity and unmet need in PD. Behavioral economics-based interventions employing wearable devices (i.e. gamification) are well defined and have successfully increased PA in a variety of populations but have not been studied in individuals with chronic neurologic diseases like PD. Such interventions can also be individualized, remotely deployed and scaled widely to increase access. The investigators' preliminary data from an open-label feasibility trial demonstrate that Veterans with PD are: 1) willing and able to adopt technologies required for the intervention; and 2) respond to the intervention, increasing step counts by ~20%.

Innovation: This will be the first randomized clinical trial to incorporate behavioral economic principles using gamification to increase physical activity among Veterans with PD. It will also be innovative by directly examining the impact of these interventions on clinical outcomes rather than just step counts. Further the investigators will investigate the relationship between increasing steps alone compared to exercise intensity and clinical outcomes. To improve scalability and decrease burden on Veterans, the entire study will be conducted completed remotely including enrollment and interventions.

Specific Aims: Aim 1: To determine whether remotely deployed gamification interventions in Veterans with PD improve physical activity PA levels measured by average daily step counts using Fitbits. Aim 2: To determine whether changes in PA resulting from gamification affect motor symptoms in Veterans with PD (tremor, bradykinesia, immobility) measured by wearable sensors (Parkinson's KinetiGraph,PKG). Aim 3: To determine whether changes in PA resulting from gamification interventions affect NMS measured using validated questionnaires completed through a web-based digital health platform. Aim 4: To conduct a qualitative process evaluation and implementation analysis to inform implementation efforts within VA.

Methodology: Veterans with PD (n=110) will be enrolled into a randomized, controlled trial comprised of a 12-week intervention and a 12-week follow-up. Wearable devices will be used to passively monitor physical activity levels (steps and moderate/vigorous, MVPA). Clinical outcomes will be captured by the PKG (motor parkinsonism) and validated questionnaires completed through a digital health platform (non-motor symptoms) Interventions will be deployed using Way to Health, a technology platform that the investigators have demonstrated is feasible to use within the VA Health System. Outcomes will include physical activity in steps (primary), MVPA and motor and non-motor clinical outcomes.

Impact: Personalized strategies using digital health technology to increase physical activity would be highly scalable with broad reach, improving the symptoms and lives of countless people living with PD.

Being tested
Gamification, Feedback control
Keywords
Parkinson Disease, Exercise, Economics, Behavioral
Medical subject headings
Parkinson Disease, Motor Activity, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GamificationBehavioural

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

  • Feedback controlBehavioural

    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

Study groups in NCT07286994
Study groupRoleWhat they receive
GamificationExperimentalSubjects will participate in an automated gamification intervention with loss or gain of points based on reaching a step goal target
Receives: Behavioral: Gamification
Feedback controlActive comparatorSubjects 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
Receives: Behavioral: Feedback control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: end of intervention period (week 26)

  2. 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 Parkinson's KinetiGraph (PKG) by Empatica device. Bradykinesia scores are numeric, with higher numbers indicating more severe symptoms.

    Measured: end of intervention period (week 26)

  3. 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 Parkinson's Disease (PD). Questions are subdivided into various non-motor domains (cardiovascular, sleep, mood, hallucinations, memory, gastrointestinal (GI), urinary, sexual function, and miscellaneous). Higher scores indicate more severe symptoms.

    Measured: end of intervention period (week 26)

Secondary outcomes (1)
  1. Change in Moderate/Vigorous Physical Activity (MVPA)

    Comparison of changes in MVPA comparing gamification to control subjects. MVPA is measured using the wrist-worn Fitbit device. The Fitbit app calculates an average number of minutes/day in MVPA.

    Measured: end of intervention period (week 26)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2025
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion30 Sep 2029 (estimated)
  4. Study completion30 Sep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects will be randomized 1:1 to either a gamification intervention or control arm
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07286994
Sponsor's protocol ID
NURM-003-25S
Status last verified
Sep 2026
First submitted
3 Dec 2025
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Gamification in people with Parkinson Disease, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact James F Morley, MD PhD ((215) 823-5800 ext. 3285, James.Morley@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in step counts (time frame: end of intervention period (week 26)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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