iPACES v3 MCI NIA Protocol Copied for iPACES v4 PD NINDS (iPACES-PD)

April 11, 2023 updated by: iPACES LLC

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)

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.).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

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

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

Study Contact Backup

Study Locations

  • United States
    • New York
      • Clifton Park, New York, United States, 12065
        • remote trial conducted in-home or nearby, across the USA; via iPACES app/video-conference/mail
        • Contact:
        • Principal Investigator:
          • Cay Anderson-Hanley, PhD
        • Principal Investigator:
          • Bob Gillen, PhD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. 50 years of age or older
  2. 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); 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:

  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, etc.)
  6. significant uncontrolled tremor 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 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
change from baseline to 3 months
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
change from baseline to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
change from baseline to 3 months
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
change from baseline to 3 months
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
change from baseline to 3 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
Center for Balance, Mobility & Wellness at Gordon College

Investigators

  • Principal Investigator: Cay Anderson-Hanley, PhD, iPACES LLC
  • Principal Investigator: Bob Gillen, 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 (Anticipated)

August 1, 2023

Primary Completion (Anticipated)

August 1, 2025

Study Completion (Anticipated)

August 1, 2026

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

April 11, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021 iPACES v3 MCI NIA copy PD

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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