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

November 18, 2021 updated by: iPACES LLC

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: self-enrollment option www.myipaces.org

Study Locations

  • United States
    • New York
      • Clifton Park, New York, United States, 12065
        • Recruiting
        • remote trial conducted via video-conference/mail in-home all locations in the continental USA
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
executive function
Time Frame: change from baseline to 6 months
cognitive function composite score from neuropsychological tests (e.g., Stroop)
change from baseline to 6 months
everyday function
Time Frame: change from baseline to 6 months
subjective cognitive function in everyday living (e.g., Ecological Validity Scale)
change from baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biomarker
Time Frame: change from baseline to 6 months
biomarker (dried blood spot samples; DBSS) linking exercise to cognitive function (e.g., Brain Derived Neurotrophic Factor)
change from baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iPACES LLC

Collaborators

Albany Medical College
1st Playable Productions
Pacific Brain Health Center
Adirondack Neuropsychological Associates

Investigators

  • Principal Investigator: Cay Anderson-Hanley, PhD, iPACES LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2021

Primary Completion (Anticipated)

May 31, 2022

Study Completion (Anticipated)

August 31, 2022

Study Registration Dates

First Submitted

July 23, 2021

First Submitted That Met QC Criteria

August 11, 2021

First Posted (Actual)

August 17, 2021

Study Record Updates

Last Update Posted (Actual)

November 22, 2021

Last Update Submitted That Met QC Criteria

November 18, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIA1R44AG071063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

de-identified data will be made available in downloadable form

IPD Sharing Time Frame

1-3 years depending upon pace of enrollment

IPD Sharing Access Criteria

IPD sharing access may be requested at support@myipaces.org

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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