The Interactive Physical and Cognitive Exercise System

NCT ID: NCT03069391

Last Updated: 2020-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-04

Study Completion Date

2022-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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Alzheimer Disease, Early Onset MCI Aging Mild Cognitive Impairment Neurocognitive Disorder Cognitive Impairment Cognitive Change

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Crossover RCT: participants are randomly assigned to start with one form of intervention and then crossover to another form of the intervention.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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physical, cognitive, then interactive

physical exercise alone (PES) first, then iPACES

Group Type ACTIVE_COMPARATOR

physical exercise alone (PES) first

Intervention Type BEHAVIORAL

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)

interactive Physical and Cognitive Exercise (iPACES™)

Intervention Type DEVICE

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)

cognitive, physical, then interactive

cognitive exercise alone (iCE) first, then iPACES

Group Type ACTIVE_COMPARATOR

cognitive exercise alone (iCE) first

Intervention Type DEVICE

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)

interactive Physical and Cognitive Exercise (iPACES™)

Intervention Type DEVICE

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)

Interventions

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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)

Intervention Type BEHAVIORAL

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)

Intervention Type 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)

Intervention Type DEVICE

Other Intervention Names

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PES iCE iPACES™

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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1st Playable Productions

OTHER

Sponsor Role collaborator

Albany Medical College

OTHER

Sponsor Role collaborator

Skidmore College

OTHER

Sponsor Role collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Union College, New York

OTHER

Sponsor Role lead

Responsible Party

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Cay Anderson-Hanley, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cay Anderson-Hanley, PhD

Role: PRINCIPAL_INVESTIGATOR

Union College

Locations

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Healthy Aging & Neuropsychology Lab @ Union College

Schenectady, New York, United States

Site Status

Countries

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United States

References

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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-Exergame for Mild Cognitive Impairment (MCI). J Clin Med. 2018 Aug 30;7(9):249. doi: 10.3390/jcm7090249.

Reference Type RESULT
PMID: 30200183 (View on PubMed)

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 impairment and caregivers. Clin Interv Aging. 2018 Sep 4;13:1565-1577. doi: 10.2147/CIA.S160756. eCollection 2018.

Reference Type RESULT
PMID: 30233154 (View on PubMed)

Other Identifiers

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1R41AG053120-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16028

Identifier Type: -

Identifier Source: org_study_id

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