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The Interactive Physical and Cognitive Exercise System (iPACES™)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03069391
Recruitment Status : Unknown
Verified March 2020 by Cay Anderson-Hanley, PhD, Union College, New York.
Recruitment status was:  Active, not recruiting
First Posted : March 3, 2017
Last Update Posted : March 31, 2020
Sponsor:
Collaborators:
1st Playable Productions
Albany Medical College
Skidmore College
University of Illinois at Urbana-Champaign
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Cay Anderson-Hanley, PhD, Union College, New York

Study Description
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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
Alzheimer Disease, Early Onset MCI Aging Mild Cognitive Impairment Neurocognitive Disorder Cognitive Impairment Cognitive Change Behavioral: physical exercise alone (PES) first Device: cognitive exercise alone (iCE) first Device: interactive Physical and Cognitive Exercise (iPACES™) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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.
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 : March 4, 2017
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: 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 Name: 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 Name: iPACES™


Outcome Measures
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Primary Outcome Measures :
  1. executive function composite score [ Time Frame: 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) [ Time Frame: change over time from baseline to 3 months ]
    change in amount in saliva sample over time (pg/ml) per ELISA

  2. Sit-Stand Test [ Time Frame: 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
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03069391


Locations
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United States, New York
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
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Principal Investigator: Cay Anderson-Hanley, PhD Union College
More Information
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Publications of Results:

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Responsible Party: Cay Anderson-Hanley, PhD, Associate Professor, Union College, New York
ClinicalTrials.gov Identifier: NCT03069391    
Other Study ID Numbers: 16028
1R41AG053120-01 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Cay Anderson-Hanley, PhD, Union College, New York:
exercise
exergame
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Neurocognitive Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Mental Disorders
Cognition Disorders