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

iPACES

Status: Not yet enrolling

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

Treatments: Device: iPACES (interactive Physical and Cognitive Exercise System); Device: PACE (Physical and Cognitive Exercise)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05810454

2021 iPACES v3 MCI NIA copy PD

Details and patient eligibility

About

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.).

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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)

3. 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

iPACES (interactive Physical and Cognitive Exercise System)

Experimental group

Description:

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.

Treatment:

Device: iPACES (interactive Physical and Cognitive Exercise System)

PACE (physical and cognitive exercise)

Active Comparator group

Description:

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.

Treatment:

Device: PACE (Physical and Cognitive Exercise)