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

NCT05009524 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-11-22

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Pacific Brain Health Center

    collaborator UNKNOWN
  • 1st Playable Productions

    collaborator OTHER
  • Adirondack Neuropsychological Associates

    collaborator UNKNOWN
  • Albany Medical College

    collaborator OTHER
  • iPACES LLC

    lead INDUSTRY

Principal Investigators

  • Cay Anderson-Hanley, PhD · iPACES LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-23
Primary Completion
2022-05-31
Completion
2022-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05009524 on ClinicalTrials.gov