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

Status unconfirmed · Not applicable

Conditions studied: MCI, Mild Cognitive Impairment, Alzheimer Disease, Dementia

In brief

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.

Key facts

Study ID

NCT05009524

Run by

iPACES LLC

People needed

120

Starts

2021-08-23

Expected to finish

2022-08-31

Last updated by the study team

2021-11-22

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• remote trial conducted via video-conference/mail in-home all locations in the continental USA — Clifton Park, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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