iPACES v3 MCI NIA Protocol Copied for iPACES v4 PD NINDS

ConditionsParkinson's Disease PD Mild Cognitive Impairment MCI

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age50+

SponsoriPACES LLC

About this trial

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.).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: iPACES (interactive Physical and Cognitive Exercise System)Experimental treatment 1 intervention

Group B: PACE (physical and cognitive exercise)Active comparator 1 intervention

Trial outcomes

Primary outcomes

executive function

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

Time frame