NCT05009524

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

August 23, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

9 months

First QC Date

July 23, 2021

Last Update Submit

November 18, 2021

Conditions

MCIMild Cognitive ImpairmentAlzheimer DiseaseDementia

Keywords

ADRDexerciseexergamephysical activityneuro-exergamingneuropsychologicalcognitivedual-taskinteractive

Outcome Measures

Primary Outcomes (2)

  • executive function

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

    change from baseline to 6 months

  • everyday function

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

    change from baseline to 6 months

Secondary Outcomes (1)

  • biomarker

    change from baseline to 6 months

Study Arms (2)

iPACES (interactive Physical and Cognitive Exercise System)

EXPERIMENTAL

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)

PACE (physical and cognitive exercise)

ACTIVE COMPARATOR

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)

Interventions

iPACES (interactive Physical and Cognitive Exercise System)DEVICE

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.

Also known as: neuro-exergame
iPACES (interactive Physical and Cognitive Exercise System)
PACE (Physical and Cognitive Exercise)DEVICE

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.

PACE (physical and cognitive exercise)

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Clifton Park, New York, 12065, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 30200183RESULT

  • 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.

    PMID: 30233154RESULT

  • 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.

    PMID: 29780318RESULT

  • 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.

    PMID: 22261206RESULT

  • 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.

    PMID: 27337738RESULT

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer DiseaseDementiaMotor Activity

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesBehavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Cay Anderson-Hanley, PhD

    iPACES LLC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

IreLee Clinical Research Coordinator

CONTACT

737-747-2237support@myipaces.org

self-enrollment option www.myipaces.org

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2021

First Posted

August 17, 2021

Study Start

August 23, 2021

Primary Completion

May 31, 2022

Study Completion

August 31, 2022

Last Updated

November 22, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will share

de-identified data will be made available in downloadable form

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
1-3 years depending upon pace of enrollment
Access Criteria
IPD sharing access may be requested at support@myipaces.org

Locations

US(1)