The Interactive Physical and Cognitive Exercise System

Study Overview
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Brief Summary
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This study is intended to clarify the benefits to brain health and thinking processes that result from different forms of exercise. In particular, this study will investigate the possible benefits of physical exercise (such as pedaling an under-table stationary elliptical) or mental exercise (such as playing a videogame on a portable tablet), or combining these activities together (as in the iPACES™ exergame).

Official Title
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The Interactive Physical and Cognitive Exercise System (iPACES™): A Neuro-exergame for Preventing Alzheimer's and Ameliorating Cognitive Impairment

Conditions
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Alzheimer Disease, Early Onset, MCI, Aging, Mild Cognitive Impairment, Neurocognitive Disorder, Cognitive Impairment, Cognitive Change

Intervention / Treatment
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* Behavioral: physical exercise alone (PES) first
* Device: cognitive exercise alone (iCE) first
* Device: interactive Physical and Cognitive Exercise (iPACES™)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: co-residing older adults (e.g., spouses, partners, roommates, relatives) both at least 50 years of age normative/typical cognitive function or those with Mild Cognitive Impairment (MCI) or mild Neurocognitive Disorder (mNCD) or early Alzheimer's disease adequate vision and dexterity for on-screen assessments able to pedal an under-table elliptical permission of primary care provider and cardiologist (if applicable) Exclusion Criteria: history of seizure Parkinson's disease significant dementia/memory loss

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: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Crossover RCT: participants are randomly assigned to start with one form of intervention and then crossover to another form of the intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: physical, cognitive, then interactive<br>physical exercise alone (PES) first, then iPACES | Behavioral: physical exercise alone (PES) first<br>* following 2-week placebo for all participants, participants in this arm will then start their active intervention with a randomly assigned 2-week physical exercise-only intervention, then 2-week cognitive exercise-only intervention, then 2-week and 3 month intervals of iPACES™ (interactive physical and cognitive exercise)<br>* Other names: PES;Device: interactive Physical and Cognitive Exercise (iPACES™)<br>* following 2-week placebo for all participants, participants in this arm will then start their active intervention with a randomly assigned 2-week cognitive exercise-only intervention, then 2-week physical exercise-only intervention, then 2-week and 3 month intervals of iPACES™ (interactive physical and cognitive exercise)<br>* Other names: iPACES™;|
| Active Comparator: cognitive, physical, then interactive<br>cognitive exercise alone (iCE) first, then iPACES | Device: cognitive exercise alone (iCE) first<br>* following 2-week placebo for all participants, participants in this arm will then start their active intervention with a randomly assigned 2-week cognitive exercise-only intervention, then 2-week physical exercise-only intervention, then 2-week and 3 month intervals of iPACES™ (interactive physical and cognitive exercise)<br>* Other names: iCE;Device: interactive Physical and Cognitive Exercise (iPACES™)<br>* following 2-week placebo for all participants, participants in this arm will then start their active intervention with a randomly assigned 2-week cognitive exercise-only intervention, then 2-week physical exercise-only intervention, then 2-week and 3 month intervals of iPACES™ (interactive physical and cognitive exercise)<br>* Other names: iPACES™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| executive function composite score | comprised of scores from Stroop, Trails, and Flanker | change over time from baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brain-derived neurotrophic factor (BDNF) | change in amount in saliva sample over time (pg/ml) per ELISA | change over time from baseline to 3 months | 
| Sit-Stand Test | scored performance on time and technique to move from sitting on floor to standing | change over time in score from baseline to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, exergame