iPACES v3 MCI NIA Protocol Copied for iPACES v4 PD NINDS

Not Applicable

Not yet recruiting

• Conditions: Mild Cognitive Impairment; Parkinson's Disease; PD; MCI
• Interventions: Device: PACE (Physical and Cognitive Exercise); Device: iPACES (interactive Physical and Cognitive Exercise System)

• Registration Number: NCT05810454
• Lead Sponsor: iPACES LLC

Brief Summary

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.).

Detailed 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).

Study Timeline

• Study First Submitted: 2023-03-27
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-11
• Last Update Submitted: 2023-04-11
• Study First Posted: 2023-04-12
• Last Update Posted: 2023-04-12
• Study Start: 2023-08
• Primary Completion: 2025-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PACE (physical and cognitive exercise)	PACE (Physical and Cognitive Exercise)	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.
iPACES (interactive Physical and Cognitive Exercise System)	iPACES (interactive Physical and Cognitive Exercise System)	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.

Primary Outcome Measures

Name	Time	Method
executive function	change from baseline to 3 months	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
everyday function	change from baseline to 3 months	subjective cognitive function in everyday living (e.g., Ecological Validity Scale); higher scores would indicate better outcomes

Secondary Outcome Measures

Name	Time	Method
biomarker	change from baseline to 3 months	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)
visuospatial function	change from baseline to 3 months	cognitive function composite score from neuropsychological tests (e.g., Rey-Osterrieth Complex Figure/ReyO); higher scores would indicate better performance
PD-ADLs	change from baseline to 3 months	Parkinson's Disease Activities of Daily Living (from the Unified Parkinson's Disease Rating Scale; UPDRS); lower scores would indicate better outcomes

Trial Locations

Locations (1)

remote trial conducted in-home or nearby, across the USA; via iPACES app/video-conference/mail; 🇺🇸 Clifton Park, New York, United States