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

Sponsor

iPACES LLC (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05009524

Collaborator

Pacific Brain Health Center (Other), 1st Playable Productions (Other), Adirondack Neuropsychological Associates (Other), Albany Medical College (Other)

120

Enrollment

Location

Arms

12.3

Anticipated Duration (Months)

9.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
MCI Mild Cognitive Impairment Alzheimer Disease Dementia	Device: iPACES (interactive Physical and Cognitive Exercise System) Device: PACE (Physical and Cognitive Exercise)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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 markparticipants 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)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Aug 23, 2021

Anticipated Primary Completion Date :

May 31, 2022

Anticipated Study Completion Date :

Aug 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: iPACES (interactive Physical and Cognitive Exercise System) 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. Other Names: neuro-exergame
Active Comparator: 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.	Device: PACE (Physical and Cognitive Exercise) 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.

Arm

Intervention/Treatment

Experimental: 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.

Device: iPACES (interactive Physical and Cognitive Exercise System)

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.

Other Names:

neuro-exergame

Active Comparator: 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.

Device: PACE (Physical and Cognitive Exercise)

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)