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NCT Number: NCT05810454

iPACES v3 MCI NIA Protocol Copied for iPACES v4 PD NINDS

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.).

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Clifton Park, New York, 12065, United States

Location contact

Bob Gillen, PhD

PRINCIPAL_INVESTIGATOR

Cay Anderson-Hanley, PhD

PRINCIPAL_INVESTIGATOR

DrVal Clinical Research Coordinator

CONTACT

[email protected]

737-747-2237

About this study

A specific aim is to evaluate the effects of iPACES for persons with Parkinson's Disease, while also examining 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 50 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

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, 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)

Treatment and study plan

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.

Other names: neuro-exergame

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.

Primary outcomes

  1. executive function

    Time frame: change from baseline to 3 months

    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

  2. everyday function

    Time frame: change from baseline to 3 months

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

Secondary outcomes

  1. biomarker

    Time frame: change from baseline to 3 months

    biomarker (dried blood spot samples; DBSS) linking exercise to cognitive function (e.g., planned analyses include: BDNF/Brain Derived Neurotrophic Factor and IGF-1/Insulin-like Growth Factor)

  2. visuospatial function

    Time frame: change from baseline to 3 months

    cognitive function composite score from neuropsychological tests (e.g., Rey-Osterrieth Complex Figure/ReyO); higher scores would indicate better performance

  3. PD-ADLs

    Time frame: change from baseline to 3 months

    Parkinson's Disease Activities of Daily Living (from the Unified Parkinson's Disease Rating Scale; UPDRS); lower scores would indicate better outcomes

Study contacts

Contact information is provided by the study sponsor or research team.

DrVal Clinical Research Coordinator

CONTACT

[email protected]

737-747-2237

self-enrollment option www.myipaces.org

CONTACT

Sponsors and collaborators

Lead sponsor

iPACES LLC

Industry

Collaborators

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

Registry information

Official study title

Neuro-exergaming for the Prevention and Remediation of Decline Due to Parkinson's Disease: Clinical Trial of the Interactive Physical and Cognitive Exercise System (iPACES-PD)

Acronym: iPACES-PD

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Apr 12, 2023
Registry last updated
Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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