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.).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
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 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.
remote trial conducted in-home or nearby, across the USA; via iPACES app/video-conference/mail
Clifton Park, New York, United States
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: change from baseline to 3 months
everyday function
subjective cognitive function in everyday living (e.g., Ecological Validity Scale); higher scores would indicate better outcomes
Time frame: change from baseline to 3 months
biomarker
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)
Time frame: change from baseline to 3 months
visuospatial function
cognitive function composite score from neuropsychological tests (e.g., Rey-Osterrieth Complex Figure/ReyO); higher scores would indicate better performance
Time frame: change from baseline to 3 months
PD-ADLs
Parkinson's Disease Activities of Daily Living (from the Unified Parkinson's Disease Rating Scale; UPDRS); lower scores would indicate better outcomes
Time frame: change from baseline to 3 months
self-enrollment option www.myipaces.org
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.