iPACES v3 MCI NIA Protocol Copied for iPACES v4 PD NINDS

Conditions

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

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Accepted

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.
• 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.

Study Details

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.).

Key Dates

Start date

Aug 31, 2023

Status verified

Apr 2023

Primary completion

Aug 31, 2025

Completion

Aug 31, 2026

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• 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.

Primary Outcome Measure

executive function [ Time Frame: change from baseline to 3 months ]

Central Contacts

• DrVal Clinical Research Coordinator
  737-747-2237
  [email protected]
• self-enrollment option www.myipaces.org

Locations (1)

Find similar trials in Clifton Park, NY

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