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iPACES™: The Interactive Physical and Cognitive Exercise System

Sponsor
Union College, New York (Other)
Overall Status
Unknown status
CT.gov ID
NCT03069391
Collaborator
1st Playable Productions (Other), Albany Medical College (Other), Skidmore College (Other), University of Illinois at Urbana-Champaign (Other), National Institute on Aging (NIA) (NIH)
31
Enrollment
1
Location
2
Arms
63.9
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is intended to clarify the benefits to brain health and thinking processes that result from different forms of exercise. In particular, this study will investigate the possible benefits of physical exercise (such as pedaling an under-table stationary elliptical) or mental exercise (such as playing a videogame on a portable tablet), or combining these activities together (as in the iPACES™ exergame).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: physical exercise alone (PES) first
  • Device: cognitive exercise alone (iCE) first
  • Device: interactive Physical and Cognitive Exercise (iPACES™)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Crossover RCT: participants are randomly assigned to start with one form of intervention and then crossover to another form of the intervention.Crossover RCT: participants are randomly assigned to start with one form of intervention and then crossover to another form of the intervention.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Interactive Physical and Cognitive Exercise System (iPACES™): A Neuro-exergame for Preventing Alzheimer's and Ameliorating Cognitive Impairment
Actual Study Start Date :
Mar 4, 2017
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: physical, cognitive, then interactive

physical exercise alone (PES) first, then iPACES

Behavioral: physical exercise alone (PES) first
following 2-week placebo for all participants, participants in this arm will then start their active intervention with a randomly assigned 2-week physical exercise-only intervention, then 2-week cognitive exercise-only intervention, then 2-week and 3 month intervals of iPACES™ (interactive physical and cognitive exercise)
Other Names:
  • PES

    • Device: interactive Physical and Cognitive Exercise (iPACES™)
    following 2-week placebo for all participants, participants in this arm will then start their active intervention with a randomly assigned 2-week cognitive exercise-only intervention, then 2-week physical exercise-only intervention, then 2-week and 3 month intervals of iPACES™ (interactive physical and cognitive exercise)
    Other Names:
  • iPACES™

    		•
    Active Comparator: cognitive, physical, then interactive

    cognitive exercise alone (iCE) first, then iPACES

    Device: cognitive exercise alone (iCE) first
    following 2-week placebo for all participants, participants in this arm will then start their active intervention with a randomly assigned 2-week cognitive exercise-only intervention, then 2-week physical exercise-only intervention, then 2-week and 3 month intervals of iPACES™ (interactive physical and cognitive exercise)
    Other Names:
  • iCE

    • Device: interactive Physical and Cognitive Exercise (iPACES™)
    following 2-week placebo for all participants, participants in this arm will then start their active intervention with a randomly assigned 2-week cognitive exercise-only intervention, then 2-week physical exercise-only intervention, then 2-week and 3 month intervals of iPACES™ (interactive physical and cognitive exercise)
    Other Names:
  • iPACES™

    		•

    Outcome Measures

    Primary Outcome Measures

    1. executive function composite score [change over time from baseline to 3 months]

      comprised of scores from Stroop, Trails, and Flanker

    Secondary Outcome Measures

    1. brain-derived neurotrophic factor (BDNF) [change over time from baseline to 3 months]

      change in amount in saliva sample over time (pg/ml) per ELISA

    2. Sit-Stand Test [change over time in score from baseline to 3 months]

      scored performance on time and technique to move from sitting on floor to standing

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • co-residing older adults (e.g., spouses, partners, roommates, relatives)

    • both at least 50 years of age

    • normative/typical cognitive function or those with Mild Cognitive Impairment (MCI) or mild Neurocognitive Disorder (mNCD) or early Alzheimer's disease

    • adequate vision and dexterity for on-screen assessments

    • able to pedal an under-table elliptical

    • permission of primary care provider and cardiologist (if applicable)

    Exclusion Criteria:

    • history of seizure

    • Parkinson's disease

    • significant dementia/memory loss

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Healthy Aging & Neuropsychology Lab @ Union College Schenectady New York United States 12308

    Sponsors and Collaborators

    • Union College, New York
    • 1st Playable Productions
    • Albany Medical College
    • Skidmore College
    • University of Illinois at Urbana-Champaign
    • National Institute on Aging (NIA)

    Investigators

    • Principal Investigator: Cay Anderson-Hanley, PhD, Union College

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cay Anderson-Hanley, PhD, Associate Professor, Union College, New York
    ClinicalTrials.gov Identifier:
    NCT03069391
    Other Study ID Numbers:
    • 16028
    • 1R41AG053120-01
    First Posted:
    Mar 3, 2017
    Last Update Posted:
    Mar 31, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Cay Anderson-Hanley, PhD, Associate Professor, Union College, New York
    exercise
    exergame
    Additional relevant MeSH terms:
    Alzheimer Disease
    Cognitive Dysfunction
    Neurocognitive Disorders

    Study Results

    No Results Posted as of Mar 31, 2020