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

Not Applicable

• Conditions: Mild Cognitive Impairment; MCI; Dementia; Alzheimer Disease
• Interventions: Device: iPACES (interactive Physical and Cognitive Exercise System); Device: PACE (Physical and Cognitive Exercise)

• Registration Number: NCT05009524
• Lead Sponsor: iPACES LLC

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2021-07-23
• Study First Submitted QC: 2021-08-11
• Study First Posted: 2021-08-17
• Study Start: 2021-08-23
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-22
• Primary Completion: 2022-05-31
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. 50 years of age or older
2. co-residing study partner (spouse, adult child, roommate in same home) willing to participate in the study as an exercising participant as well
3. 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)
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)
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

1. already exercising at recommended levels (45 min of moderate intensity aerobic exercise 5-7x/wk)
2. significant history of cardiovascular problems
3. significant history of stroke
4. significant history of memory problems (e.g., dementia/Alzheimer's)
5. significant history of other neurological condition (e.g., seizures, Parkinson's, etc.)
6. tremor (idiopathic) such that would interfere with touch-screen use required throughout the study (surveys, game-play, etc.)
7. not prone to cybersickness (e.g., "car sickness" or problems with "screen time")
8. cannot provide informed consent (i.e., when phone screened with the Impaired Decision Making Capacity screen)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iPACES (interactive Physical and Cognitive Exercise System)	iPACES (interactive Physical and Cognitive Exercise System)	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.
PACE (physical and cognitive exercise)	PACE (Physical and Cognitive Exercise)	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.

Primary Outcome Measures

Name	Time	Method
executive function	change from baseline to 6 months	cognitive function composite score from neuropsychological tests (e.g., Stroop)
everyday function	change from baseline to 6 months	subjective cognitive function in everyday living (e.g., Ecological Validity Scale)

Secondary Outcome Measures

Name	Time	Method
biomarker	change from baseline to 6 months	biomarker (dried blood spot samples; DBSS) linking exercise to cognitive function (e.g., Brain Derived Neurotrophic Factor)

Trial Locations

Locations (1)

remote trial conducted via video-conference/mail in-home all locations in the continental USA; 🇺🇸 Clifton Park, New York, United States