iPACES-PD: iPACES v3 MCI NIA Protocol Copied for iPACES v4 PD NINDS

Sponsor

iPACES LLC (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05810454

Collaborator

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

120

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

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), 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.).

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease PD Mild Cognitive Impairment MCI	Device: iPACES (interactive Physical and Cognitive Exercise System) Device: PACE (Physical and Cognitive Exercise)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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)

Anticipated Study Start Date :

Aug 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2025

Anticipated Study Completion Date :

Aug 1, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

executive function [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
everyday function [change from baseline to 3 months]
subjective cognitive function in everyday living (e.g., Ecological Validity Scale); higher scores would indicate better outcomes

Secondary Outcome Measures

biomarker [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)
visuospatial function [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
PD-ADLs [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)
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)