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

Primary Purpose

MCI, Mild Cognitive Impairment, Alzheimer Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

iPACES (interactive Physical and Cognitive Exercise System)

PACE (Physical and Cognitive Exercise)

About this trial

This is an interventional treatment trial for MCI focused on measuring ADRD, exercise, exergame, physical activity, neuro-exergaming, neuropsychological, cognitive, dual-task, interactive

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iPACES (interactive Physical and Cognitive Exercise System)

PACE (physical and cognitive exercise)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

executive function

cognitive function composite score from neuropsychological tests (e.g., Stroop)

everyday function

subjective cognitive function in everyday living (e.g., Ecological Validity Scale)

Secondary Outcome Measures

biomarker

biomarker (dried blood spot samples; DBSS) linking exercise to cognitive function (e.g., Brain Derived Neurotrophic Factor)

Full Information

NCT ID

NCT05009524

First Posted

July 23, 2021

Last Updated

November 18, 2021

Sponsor

iPACES LLC

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05009524

Brief Title

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

Acronym

iPACES

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)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

August 23, 2021 (Actual)

Primary Completion Date

May 31, 2022 (Anticipated)

Study Completion Date

August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

iPACES LLC

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

MCI, Mild Cognitive Impairment, Alzheimer Disease, Dementia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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 mark

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

iPACES (interactive Physical and Cognitive Exercise System)

Arm Type

Experimental

Arm Description

Arm Title

PACE (physical and cognitive exercise)

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

iPACES (interactive Physical and Cognitive Exercise System)

Other Intervention Name(s)

neuro-exergame

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

PACE (Physical and Cognitive Exercise)

Intervention Description

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 Information:

Title

executive function

Description

cognitive function composite score from neuropsychological tests (e.g., Stroop)

Time Frame

change from baseline to 6 months

Title

everyday function

Description

subjective cognitive function in everyday living (e.g., Ecological Validity Scale)

Time Frame

change from baseline to 6 months

Secondary Outcome Measure Information:

Title

biomarker

Description

biomarker (dried blood spot samples; DBSS) linking exercise to cognitive function (e.g., Brain Derived Neurotrophic Factor)

Time Frame

change from baseline to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

IreLee Clinical Research Coordinator

Phone

737-747-2237

support@myipaces.org

First Name & Middle Initial & Last Name or Official Title & Degree

self-enrollment option www.myipaces.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cay Anderson-Hanley, PhD

Organizational Affiliation

iPACES LLC

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Clifton Park

State/Province

New York

ZIP/Postal Code

12065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

IreLee Clinical Research Coordinator

Phone

737-747-2237

support@myipaces.org

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

Citations:

PubMed Identifier

30200183

Citation

Wall K, Stark J, Schillaci A, Saulnier ET, McLaren E, Striegnitz K, Cohen BD, Arciero PJ, Kramer AF, Anderson-Hanley C. The Enhanced Interactive Physical and Cognitive Exercise System (iPACESTM v2.0): Pilot Clinical Trial of an In-Home iPad-Based Neuro-Exergame for Mild Cognitive Impairment (MCI). J Clin Med. 2018 Aug 30;7(9):249. doi: 10.3390/jcm7090249.

Results Reference

result

PubMed Identifier

30233154

Citation

Anderson-Hanley C, Stark J, Wall KM, VanBrakle M, Michel M, Maloney M, Barcelos N, Striegnitz K, Cohen BD, Kramer AF. The interactive Physical and Cognitive Exercise System (iPACES): effects of a 3-month in-home pilot clinical trial for mild cognitive impairment and caregivers. Clin Interv Aging. 2018 Sep 4;13:1565-1577. doi: 10.2147/CIA.S160756. eCollection 2018.

Results Reference

result

PubMed Identifier

29780318

Citation

Anderson-Hanley C, Barcelos NM, Zimmerman EA, Gillen RW, Dunnam M, Cohen BD, Yerokhin V, Miller KE, Hayes DJ, Arciero PJ, Maloney M, Kramer AF. The Aerobic and Cognitive Exercise Study (ACES) for Community-Dwelling Older Adults With or At-Risk for Mild Cognitive Impairment (MCI): Neuropsychological, Neurobiological and Neuroimaging Outcomes of a Randomized Clinical Trial. Front Aging Neurosci. 2018 May 4;10:76. doi: 10.3389/fnagi.2018.00076. eCollection 2018.

Results Reference

result

PubMed Identifier

22261206

Citation

Anderson-Hanley C, Arciero PJ, Brickman AM, Nimon JP, Okuma N, Westen SC, Merz ME, Pence BD, Woods JA, Kramer AF, Zimmerman EA. Exergaming and older adult cognition: a cluster randomized clinical trial. Am J Prev Med. 2012 Feb;42(2):109-19. doi: 10.1016/j.amepre.2011.10.016.

Results Reference

result

PubMed Identifier

27337738

Citation

Anderson-Hanley C, Maloney M, Barcelos N, Striegnitz K, Kramer A. Neuropsychological Benefits of Neuro-Exergaming for Older Adults: A Pilot Study of an Interactive Physical and Cognitive Exercise System (iPACES). J Aging Phys Act. 2017 Jan;25(1):73-83. doi: 10.1123/japa.2015-0261. Epub 2016 Aug 24.

Results Reference

result

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

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