iPACES v3 MCI NIA Protocol Copied for iPACES v4 PD NINDS

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

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

Treatments tested in this trial

  • iPACES (interactive Physical and Cognitive Exercise System)
  • PACE (Physical and Cognitive Exercise)

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

iPACES LLC

Lead sponsor

Pacific Brain Health Center

Collaborator

1st Playable Productions

Collaborator

Adirondack Neuropsychological Associates

Collaborator

Albany Medical College

Collaborator

Center for Balance, Mobility & Wellness at Gordon College

Collaborator