iPACES v3 MCI NIA Protocol Copied for iPACES v4 PD NINDS

NCT05810454 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2021 iPACES v3 MCI NIA copy PD
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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), to evaluate effects for persons with Parkinson's Disease (PD). Participants will include persons with PD, and potentially, also their co-residing partner, who will exercise at home or accessible location, 3-5 times per week for at least 6 months, with follow-up one month after the main intervention. All participation is "remote" (completed at home, or location of choice), utilizing either one's own equipment ("bring-your-own-devices" BYODs: pedaler, phone/tablet, smart-watch) or some equipment which may be supplied by the grant-funded study and shipped directly to the home; all study measures are completed remotely (e.g., via phone app, website, biometric device, videoconference, email, snail mail, etc.).

Conditions

Parkinson's Disease; PD; Mild Cognitive Impairment; MCI

Keywords

Parkinson; exercise; exergame; physical activity; neuro-exergaming; neuropsychological; cognitive; dual-task; interactive; executive function

Outcome Measures

Primary Outcomes (2)

• executive function

  cognitive function composite score from neuropsychological tests (e.g., Stroop); higher scores on the standardized composite would be centered around zero, and higher scores would indicate better performance

  change from baseline to 3 months

• everyday function

  subjective cognitive function in everyday living (e.g., Ecological Validity Scale); higher scores would indicate better outcomes

  change from baseline to 3 months

Secondary Outcomes (3)

• biomarker

  change from baseline to 3 months

• visuospatial function

  change from baseline to 3 months

• PD-ADLs

  change from baseline to 3 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

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• 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) 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); Spanish language option anticipated soon 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

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, etc.)
• significant uncontrolled tremor 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)

Sponsors & Collaborators

• iPACES LLC: lead
• Pacific Brain Health Center: collaborator
• 1st Playable Productions: collaborator
• Adirondack Neuropsychological Associates: collaborator
• Albany Medical College: collaborator
• Center for Balance, Mobility & Wellness at Gordon College: collaborator

Study Sites (1)

remote trial conducted in-home or nearby, across the USA; via iPACES app/video-conference/mail

Clifton Park, New York, 12065, United States

Location

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: 30200183 RESULT

• 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: 30233154 RESULT

• 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: 29780318 RESULT

• 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: 22261206 RESULT

• 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: 27337738 RESULT

MeSH Terms

Conditions

Parkinson Disease; Cognitive Dysfunction; Motor Activity

Interventions

Physical Examination

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Bob Gillen, PhD

  iPACES LLC

  PRINCIPAL INVESTIGATOR

• Cay Anderson-Hanley, PhD

  iPACES LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

DrVal Clinical Research Coordinator

CONTACT

737-747-2237; support@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
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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 3 months, then PACE crosses over to iPACES for 3 months, and all followed a final month

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 12, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• 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)