The Interactive Physical and Cognitive Exercise System (v3) for Mild Cognitive Impairment (MCI)

Alzheimer Disease Clinical Trial

— iPACES  

Official title:

The Interactive Physical and Cognitive Exercise System (iPACES v3) to Benefit Brain Health in Mild Cognitive Impairment (MCI): A Randomized Clinical Trial of Neuro-exergaming Pedal-to-play (iPACES) vs Pedal-while-play (PACE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05009524
• Other study ID #: NIA1R44AG071063
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: November 2021
• Source: iPACES LLC
• Contact: IreLee 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). Participants will include persons with MCI and their co-residing partner who both exercise at home 3-5 times per week for at least 6 months and are followed through one year. All participation is "remote" (completed at home), with all equipment (pedaler, tablet, etc.) supplied directly to the home, and with all study measures completed via videoconference and mail.

Description:

A specific aim is to evaluate 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: Recruiting
• Enrollment: 120
• Est. completion date: August 31, 2022
• Est. primary completion date: May 31, 2022
• 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. co-residing study partner (spouse, adult child, roommate in same home) willing to participate in the study as an exercising participant as well

3. self or partner 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)

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, Parkinson's, etc.)

6. tremor (idiopathic) 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

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• MCI
• Mild Cognitive Impairment

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 via video-conference/mail in-home all locations in the continental USA	Clifton Park	New York

Sponsors (5)

Lead Sponsor	Collaborator
iPACES LLC	1st Playable Productions, Adirondack Neuropsychological Associates, Albany Medical 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 im — 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 (iPACES(TM) v2.0): Pilot Clinical Trial of an In-Home iPad-Based Neuro- — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	executive function	cognitive function composite score from neuropsychological tests (e.g., Stroop)	change from baseline to 6 months
Primary	everyday function	subjective cognitive function in everyday living (e.g., Ecological Validity Scale)	change from baseline to 6 months
Secondary	biomarker	biomarker (dried blood spot samples; DBSS) linking exercise to cognitive function (e.g., Brain Derived Neurotrophic Factor)	change from baseline to 6 months