The Interactive Physical and Cognitive Exercise System (v3) for Mild Cognitive Impairment (MCI)

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). Participants will include persons with MCI and their co-residing partner who both exercise at home 3-5 times per week for at least 6 months and are followed through one year. All participation is remote (completed at home), with all equipment (pedaler, tablet, etc.) supplied directly to the home, and with all study measures completed via videoconference and mail.

Detailed Description
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A specific aim is to evaluate 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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The Interactive Physical and Cognitive Exercise System (iPACES v3) to Benefit Brain Health in Mild Cognitive Impairment (MCI): A Randomized Clinical Trial of Neuro-exergaming Pedal-to-play (iPACES) vs Pedal-while-play (PACE)

Conditions
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MCI, Mild Cognitive Impairment, Alzheimer Disease, Dementia

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 co-residing study partner (spouse, adult child, roommate in same home) willing to participate in the study as an exercising participant as well self or partner 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) available for participation for one year (tablet surveys, videoconference evaluations) willing and able to exercise 3-5 times per week for at least 6 months can pedal an under-table elliptical can read off of a small tablet screen proficient in English (speaking and reading for completion of interview, surveys, game) can participate in testing and read and operate tablet touch screen (adequate hearing, vision, speech) written approval from primary care physician and cardiologist (if applicable) to participate in exercise for this study 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, Parkinson's, etc.) tremor (idiopathic) 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 6 months, then PACE crosses over to iPACES and all followed out to 1-year mark
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) | change from baseline to 6 months | 
| everyday function | subjective cognitive function in everyday living (e.g., Ecological Validity Scale) | change from baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| biomarker | biomarker (dried blood spot samples; DBSS) linking exercise to cognitive function (e.g., Brain Derived Neurotrophic Factor) | change from baseline to 6 months | 

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