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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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
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.
- Conditions
- Parkinson Disease
- 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 group | Role | What they receive |
|---|---|---|
| Gamification | Experimental | Subjects will participate in an automated gamification intervention with loss or gain of points based on reaching a step goal target Receives: 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 Receives: Behavioral: Feedback control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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)
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)
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.
- First posted16 Dec 2025
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- James F Morley, MD PhD, Principal investigator, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized-controlled Trial of Remotely-deployed Gamification Interventions to Increase Physical Activity in Veterans With Parkinsons Disease
- ClinicalTrials.gov ID
- NCT07286994
- Acronym / sponsor ID
- NURM-003-25S
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Exercise, Economics, Behavioral
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomized 1:1 to either a gamification intervention or control arm
| Arm | Type | Receives |
|---|---|---|
| Gamification | Experimental | Behavioral: GamificationSubjects will participate in an automated gamification intervention with loss or gain of points based on reaching a step goal target |
| Feedback control | Active comparator | Behavioral: Feedback controlSubjects 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 |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GamificationSubjects will participate in an automated gamification intervention with loss or gain of points based on reaching a step goal target | Behavioural | Gamification |
| Feedback controlSubjects 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 | Behavioural | Feedback control |
Primary outcome
Change in step counts
Time frame: end of intervention period (week 26)
Primary outcome: change in daily step counts from baseline to intervention. H1a: subjects randomized to gamification will increase step counts significantly more than controls.
Bradykinesia
Time frame: end of intervention period (week 26)
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.
Non-motor symptoms questionnaire (NMSQ)
Time frame: end of intervention period (week 26)
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.
1 secondary outcome
Change in Moderate/Vigorous Physical Activity (MVPA)
Time frame: end of intervention period (week 26)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James F Morley, MD PhD principal investigator
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
1 site in 1 country: see every site and its status.
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.