iPACES v3 MCI NIA Protocol Copied for iPACES v4 PD NINDS

Parkinson's Disease Clinical Trial

— iPACES-PD  

Official title:

Neuro-exergaming for the Prevention and Remediation of Decline Due to Parkinson's Disease: Clinical Trial of the Interactive Physical and Cognitive Exercise System (iPACES-PD)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05810454
• Other study ID #: 2021 iPACES v3 MCI NIA copy PD
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Est. completion date: August 2026

Study information

• Verified date: April 2023
• Source: iPACES LLC
• Contact: DrVal Clinical Research Coordinator
• Phone: 737-747-2237
• Email: support[@]myipaces.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: August 2026
• Est. primary completion date: August 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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)

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:

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• MCI
• Mild Cognitive Impairment
• Parkinson Disease
• Parkinson's Disease
• PD

Intervention

Device:
• iPACES (interactive Physical and Cognitive Exercise System)
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)
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.

Locations

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

Sponsors (6)

Lead Sponsor	Collaborator
iPACES LLC	1st Playable Productions, Adirondack Neuropsychological Associates, Albany Medical College, Center for Balance, Mobility & Wellness at Gordon College, Pacific Brain Health Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

Anderson-Hanley C, Arciero PJ, Brickman AM, Nimon JP, Okuma N, Westen SC, Merz ME, Pence BD, Woods JA, Kramer AF, Zimmerman EA. Exergaming and older adult cognition: a cluster randomized clinical trial. Am J Prev Med. 2012 Feb;42(2):109-19. doi: 10.1016/j — View Citation

Anderson-Hanley C, Barcelos NM, Zimmerman EA, Gillen RW, Dunnam M, Cohen BD, Yerokhin V, Miller KE, Hayes DJ, Arciero PJ, Maloney M, Kramer AF. The Aerobic and Cognitive Exercise Study (ACES) for Community-Dwelling Older Adults With or At-Risk for Mild Co — View Citation

Anderson-Hanley C, Maloney M, Barcelos N, Striegnitz K, Kramer A. Neuropsychological Benefits of Neuro-Exergaming for Older Adults: A Pilot Study of an Interactive Physical and Cognitive Exercise System (iPACES). J Aging Phys Act. 2017 Jan;25(1):73-83. do — View Citation

Anderson-Hanley C, Stark J, Wall KM, VanBrakle M, Michel M, Maloney M, Barcelos N, Striegnitz K, Cohen BD, Kramer AF. The interactive Physical and Cognitive Exercise System (iPACES): effects of a 3-month in-home pilot clinical trial for mild cognitive imp — View Citation

Wall K, Stark J, Schillaci A, Saulnier ET, McLaren E, Striegnitz K, Cohen BD, Arciero PJ, Kramer AF, Anderson-Hanley C. The Enhanced Interactive Physical and Cognitive Exercise System (iPACESTM v2.0): Pilot Clinical Trial of an In-Home iPad-Based Neuro-Ex — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	change from baseline to 3 months
Primary	everyday function	subjective cognitive function in everyday living (e.g., Ecological Validity Scale); higher scores would indicate better outcomes	change from baseline to 3 months
Secondary	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)	change from baseline to 3 months
Secondary	visuospatial function	cognitive function composite score from neuropsychological tests (e.g., Rey-Osterrieth Complex Figure/ReyO); higher scores would indicate better performance	change from baseline to 3 months
Secondary	PD-ADLs	Parkinson's Disease Activities of Daily Living (from the Unified Parkinson's Disease Rating Scale; UPDRS); lower scores would indicate better outcomes	change from baseline to 3 months