Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-31 @ 11:26 AM
Study NCT ID:
NCT07286994
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gamification and Physical Activity in PD
Sponsor:
VA Office of Research and Development
Organization:
Study Overview
Official Title:
Randomized-controlled Trial of Remotely-deployed Gamification Interventions to Increase Physical Activity in Veterans With Parkinsons Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 we 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.
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 we 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: