The Interactive Physical and Cognitive Exercise System (iPACES™)

March 29, 2020 updated by: Cay Anderson-Hanley, PhD, Union College, New York

The Interactive Physical and Cognitive Exercise System (iPACES™): A Neuro-exergame for Preventing Alzheimer's and Ameliorating Cognitive Impairment

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Schenectady, New York, United States, 12308
        • Healthy Aging & Neuropsychology Lab @ Union College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: 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™
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
executive function composite score
Time Frame: change over time from baseline to 3 months
comprised of scores from Stroop, Trails, and Flanker
change over time from baseline to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
change over time from baseline to 3 months
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
change over time in score from baseline to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Union College, New York

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2017

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

June 30, 2022

Study Registration Dates

First Submitted

February 7, 2017

First Submitted That Met QC Criteria

February 27, 2017

First Posted (Actual)

March 3, 2017

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 29, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16028
  • 1R41AG053120-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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