An interventional study of iPACES (interactive Physical and Cognitive Exercise System) and PACE (Physical and Cognitive Exercise) in Parkinson's Disease, PD and Mild Cognitive Impairment, sponsored by iPACES LLC. Status unknown at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-12.
Sponsored by iPACES LLC · Not applicable, Interventional, and Treatment
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).
4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.
This study's planned enrollment of 120 is above the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.
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4. 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:
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.
Device: iPACES (interactive Physical and Cognitive Exercise System)
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.
Device: PACE (Physical and Cognitive Exercise)
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.
Also known as: neuro-exergame
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.
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
Plan to share: Yes — de-identified data will be made available in downloadable form
Supporting information: Study protocol, Clinical study report
Time frame: 1-3 years depending upon pace of enrollment
Access criteria: IPD sharing access may be requested at support@myipaces.org
This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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