iPACES v3 MCI NIA Protocol Copied for iPACES v4 PD NINDS

Study Overview
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Brief Summary
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The primary purpose of this study is to attempt to replicate and extend promising pilot findings regarding the cognitive benefits of in-home neuro-exergaming with iPACES (interactive Physical and Cognitive Exercise System v3) for persons with mild cognitive impairment (MCI), to evaluate effects for persons with Parkinson's Disease (PD). Participants will include persons with PD, and potentially, also their co-residing partner, who will exercise at home or accessible location, 3-5 times per week for at least 6 months, with follow-up one month after the main intervention. All participation is remote (completed at home, or location of choice), utilizing either one's own equipment (bring-your-own-devices BYODs: pedaler, phone/tablet, smart-watch) or some equipment which may be supplied by the grant-funded study and shipped directly to the home; all study measures are completed remotely (e.g., via phone app, website, biometric device, videoconference, email, snail mail, etc.).

Detailed Description
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A specific aim is to evaluate the effects of iPACES for persons with Parkinson's Disease, while also examining the potentially unique contribution of combining mental and physical exercise in an interactive way: pedal-to-play (iPACES), as compared with non-interactive, but simultaneous: pedal-while-play (PACE).

Official Title
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Neuro-exergaming for the Prevention and Remediation of Decline Due to Parkinson's Disease: Clinical Trial of the Interactive Physical and Cognitive Exercise System (iPACES-PD)

Conditions
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Parkinson's Disease, PD, Mild Cognitive Impairment, MCI

Intervention / Treatment
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* Device: iPACES (interactive Physical and Cognitive Exercise System)
* Device: PACE (Physical and Cognitive Exercise)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 50 years of age or older meets criteria for MCI (per site staff/MD/neuropsychologist and confirmed by study-administered Montreal Cognitive Assessment; MoCA; score = between 16-26, non-inclusive; Milani, 2018) 4. available for participation for one year (tablet surveys, videoconference evaluations) 5. willing and able to exercise 3-5 times per week for at least 6 months 6. can pedal an under-table elliptical 7. can read off of a small tablet screen 8. proficient in English (speaking and reading for completion of interview, surveys, game); Spanish language option anticipated soon 9. can participate in testing and read and operate tablet touch screen (adequate hearing, vision, speech) 10. written approval from primary care physician and cardiologist (if applicable) to participate in exercise for this study 11. can provide informed consent Exclusion Criteria: already exercising at recommended levels (45 min of moderate intensity aerobic exercise 5-7x/wk) significant history of cardiovascular problems significant history of stroke significant history of memory problems (e.g., dementia/Alzheimer's) significant history of other neurological condition (e.g., seizures, etc.) significant uncontrolled tremor such that would interfere with touch-screen use required throughout the study (surveys, game-play, etc.) not prone to cybersickness (e.g., car sickness or problems with screen time) cannot provide informed consent (i.e., when phone screened with the Impaired Decision Making Capacity screen)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: participants are randomly assigned to either iPACES (pedal-to-play) or PACE (pedal-while-play) exergaming interventions to be completed 3-5x/wk for 3 months, then PACE crosses over to iPACES for 3 months, and all followed a final month
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iPACES (interactive Physical and Cognitive Exercise System)<br>iPACES (interactive Physical and Cognitive Exercise System) involves a pedal-to-play neuro-exergame in which physical and mental exercise are combined in an interactive way. In this condition a person will pedal to control forward motion in a tablet-based game, such as when pedaling along a virtual path and steering to different assigned errand locations. | Device: iPACES (interactive Physical and Cognitive Exercise System)<br>* iPACES involves a pedal-to-play neuro-exergame in which physical and mental exercise are combined in an interactive way. In this condition a person will pedal to control forward motion in a tablet-based game, such as when pedaling along a virtual path and steering to different assigned errand locations.<br>* Other names: neuro-exergame;|
| Active Comparator: PACE (physical and cognitive exercise)<br>PACE (Physical and Cognitive Exercise) involves a pedal-while-play experience in which physical and mental exercise are combined in a simultaneous, but not fully interactive way. In this condition a person will pedal while also separately steering in a tablet-based game, such as when pedaling while automatically progressing along a virtual path to different assigned errand locations. | Device: PACE (Physical and Cognitive Exercise)<br>* PACE involves a pedal-while-play experience in which physical and mental exercise are combined in a simultaneous, but not fully interactive way. In this condition a person will pedal while also separately steering in a tablet-based game, such as when pedaling while automatically progressing along a virtual path to different assigned errand locations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| executive function | cognitive function composite score from neuropsychological tests (e.g., Stroop); higher scores on the standardized composite would be centered around zero, and higher scores would indicate better performance | change from baseline to 3 months | 
| everyday function | subjective cognitive function in everyday living (e.g., Ecological Validity Scale); higher scores would indicate better outcomes | change from baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biomarker | biomarker (dried blood spot samples; DBSS) linking exercise to cognitive function (e.g., planned analyses include: BDNF/Brain Derived Neurotrophic Factor and IGF-1/Insulin-like Growth Factor) | change from baseline to 3 months | 
| visuospatial function | cognitive function composite score from neuropsychological tests (e.g., Rey-Osterrieth Complex Figure/ReyO); higher scores would indicate better performance | change from baseline to 3 months | 
| PD-ADLs | Parkinson's Disease Activities of Daily Living (from the Unified Parkinson's Disease Rating Scale; UPDRS); lower scores would indicate better outcomes | change from baseline to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson, exercise, exergame, physical activity, neuro-exergaming, neuropsychological, cognitive, dual-task, interactive, executive function