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

iPACES

Status: Unknown

Conditions: MCI; Alzheimer Disease; Mild Cognitive Impairment; Dementia

Treatments: Device: iPACES (interactive Physical and Cognitive Exercise System); Device: PACE (Physical and Cognitive Exercise)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05009524

NIA1R44AG071063

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

iPACES (interactive Physical and Cognitive Exercise System)

Experimental group

Description:

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.

Treatment:

Device: iPACES (interactive Physical and Cognitive Exercise System)

PACE (physical and cognitive exercise)

Active Comparator group

Description:

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.

Treatment:

Device: PACE (Physical and Cognitive Exercise)