The Aerobic & Cognitive Exercise Study

NCT ID: NCT02237560

Last Updated: 2018-05-03

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

COMPLETED

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-07-31

Brief Summary

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The purpose of this study is to clarify the benefits to brain health and thinking processes that result from different forms of exercise. This study will examine the effectiveness of cybercycling (virtual reality enhanced stationary cycling) for persons at risk for and with MCI, and compare this with the individual cognitive, behavioral, and physiological effects of physical and mental exercise alone. The Investigators hypothesis that cognitive benefit will be greatest for combined aerobic and cognitive exercise compared to physical and mental exercise alone.

Detailed Description

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This is a multi-site, randomized controlled trial. Participants will be randomized into one of three conditions for six months: cybercycle-tour, cybercycle-game, or videogame alone. Comprehensive evaluations will include: neuropsychological (e.g., executive function and memory), behavioral (e.g., compliance and effort/watts), physiological (e.g., cardiorespiratory fitness), biomarker (e.g., BDNF), and an expanded neuroimaging pilot. After the six-month intervention period, participants choose whether or not to continue exercising, using any of the three conditions.

Conditions

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Mild Cognitive Impairment Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Cybercycle-Game

Combined aerobic \& cognitive exercise for 6 months, 3-5x/week.

Group Type EXPERIMENTAL

Cybercycle-Game

Intervention Type BEHAVIORAL

Exercising on a virtual-reality enhanced stationary recumbent bicycle while playing interactive 3D video-game for 6 months, 3-5x/week.

Cybercyle-Tour

Aerobic exercise only for 6 months, 3-5x/week.

Group Type ACTIVE_COMPARATOR

Cybercyle-Tour

Intervention Type BEHAVIORAL

Exercising on virtual-reality enhanced stationary recumbent bicycle and pedaling through interactive 3D scenic bike tours for 6 months, 3-5x/week.

Game Only

Cognitive exercise only 6 months, 3-5x/week.

Group Type ACTIVE_COMPARATOR

Game Only

Intervention Type BEHAVIORAL

While seated on a stationary recumbent seat play interactive 3D video-game for 6 months, 3-5x/week (no pedaling).

Interventions

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Cybercycle-Game

Exercising on a virtual-reality enhanced stationary recumbent bicycle while playing interactive 3D video-game for 6 months, 3-5x/week.

Intervention Type BEHAVIORAL

Cybercyle-Tour

Exercising on virtual-reality enhanced stationary recumbent bicycle and pedaling through interactive 3D scenic bike tours for 6 months, 3-5x/week.

Intervention Type BEHAVIORAL

Game Only

While seated on a stationary recumbent seat play interactive 3D video-game for 6 months, 3-5x/week (no pedaling).

Intervention Type BEHAVIORAL

Other Intervention Names

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Expresso Dragon Chase Expresso Dragon Chase

Eligibility Criteria

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Inclusion Criteria

* age 50+
* able to pedal recumbent stationary bicycle
* available for regular exercise participation 3-5x/week for at least 6 months
* physician permission to exercise

Exclusion Criteria

* unstable heart condition or other significant cardiovascular history (e.g,. stroke)
* meets criteria for Alzheimer's or other dementia
* significant history of other neurological disease (e.g., seizures, Parkinson's, etc.)
* physician denial to exercise
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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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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Albany Medical Center

Albany, New York, United States

Site Status

Sidney Albert Albany Jewish Community Center

Albany, New York, United States

Site Status

Stratton VA Medical Center

Albany, New York, United States

Site Status

Hawthorne Ridge

East Greenbush, New York, United States

Site Status

Guilderland YMCA

Guilderland, New York, United States

Site Status

Glen Eddy

Niskayuna, New York, United States

Site Status

Coburg Village

Rexford, New York, United States

Site Status

Prestwick Chase

Saratoga Springs, New York, United States

Site Status

Kingsway Parkland GardenApartments

Schenectady, New York, United States

Site Status

Schaffer Heights

Schenectady, New York, United States

Site Status

Sunnyview Rehabilitation Center

Schenectady, New York, United States

Site Status

Beverwyck

Slingerlands, New York, United States

Site Status

Countries

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United States

References

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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 Cognitive Impairment (MCI): Neuropsychological, Neurobiological and Neuroimaging Outcomes of a Randomized Clinical Trial. Front Aging Neurosci. 2018 May 4;10:76. doi: 10.3389/fnagi.2018.00076. eCollection 2018.

Reference Type DERIVED
PMID: 29780318 (View on PubMed)

Other Identifiers

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R15AG042109-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HS13083

Identifier Type: -

Identifier Source: org_study_id

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