Recruiting

Interactive Exercise System

Sponsor:

iPACES LLC

Code:

NCT05009524

Conditions

MCI

Mild Cognitive Impairment

Alzheimer Disease

Dementia

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

iPACES (interactive Physical and Cognitive Exercise System)

PACE (Physical and Cognitive Exercise)

Study Details

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.

Conditions

MCI

Mild Cognitive Impairment

Alzheimer Disease

Dementia

Study ID

NCT05009524

Start date

Aug 23, 2021

Status verified date

Nov, 2021

Completion date

Aug 31, 2022

Anticipated

Primary completion date

May 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

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

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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.

Primary outcome measure

  • executive function [ Time Frame: change from baseline to 6 months ]
  • everyday function [ Time Frame: change from baseline to 6 months ]

Central Contacts and Locations

Central contacts

IreLee Clinical Research Coordinator

737-747-2237support@myipaces.org

Locations

remote trial conducted via video-conference/mail in-home all locations in the continental USA

Recruiting

Clifton Park, New York, United States, 12065

Contacts

IreLee Clinical Research Coordinator

737-747-2237support@myipaces.org

More Information

Sponsor

iPACES LLC

Last update posted

Nov 22, 2021

Last verified

Nov, 2021

Keywords

  • ADRD
  • exercise
  • exergame
  • physical activity
  • neuro-exergaming
  • neuropsychological
  • cognitive
  • dual-task
  • interactive

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by iPACES LLC on 2021-11-22.