The Aerobic & Cognitive Exercise Study (ACES)

April 30, 2018 updated by: Cay Anderson-Hanley, PhD, Union College, New York

The Cognitive Benefits of Interactive Mental and Physical Exercise for Older Adults at Risk for or With Mild Cognitive Impairment (MCI)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

111

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
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • Albany, New York, United States, 12208
        • Sidney Albert Albany Jewish Community Center
      • Albany, New York, United States, 12208
        • Stratton VA Medical Center
      • East Greenbush, New York, United States, 12061
        • Hawthorne Ridge
      • Guilderland, New York, United States, 12084
        • Guilderland YMCA
      • Niskayuna, New York, United States, 12309
        • Glen Eddy
      • Rexford, New York, United States, 12148
        • Coburg Village
      • Saratoga Springs, New York, United States, 12866
        • Prestwick Chase
      • Schenectady, New York, United States, 12304
        • Kingsway Parkland GardenApartments
      • Schenectady, New York, United States, 12308
        • Schaffer Heights
      • Schenectady, New York, United States, 12308
        • Sunnyview Rehabilitation Center
      • Slingerlands, New York, United States, 12159
        • Beverwyck

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

Yes

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cybercycle-Game
Combined aerobic & cognitive exercise for 6 months, 3-5x/week.
Behavioral: Cybercycle-Game
Exercising on a virtual-reality enhanced stationary recumbent bicycle while playing interactive 3D video-game for 6 months, 3-5x/week.
Other Names:
  • Expresso
  • Dragon Chase
Active Comparator: Cybercyle-Tour
Aerobic exercise only for 6 months, 3-5x/week.
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.
Other Names:
  • Expresso
Active Comparator: Game Only
Cognitive exercise only 6 months, 3-5x/week.
Behavioral: Game Only
While seated on a stationary recumbent seat play interactive 3D video-game for 6 months, 3-5x/week (no pedaling).
Other Names:
  • Dragon Chase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in executive function at 6-months
Time Frame: Baseline and 6-months
Change in executive function from baseline at 6-months will be assessed by using a composite executive function score obtained from scores on Digit Span Backwards, Stroop, and Color Trails.
Baseline and 6-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in weight
Time Frame: Baseline, 3-months, 6-months, 1-year
Weight and other physiological factors will be assessed at baseline, 3-months, 6-months, and 1-year follow-up
Baseline, 3-months, 6-months, 1-year
Change in mood
Time Frame: Baseline, 3-months, 6-months, 1-year follow-up
Behavioral outcomes (e.g., mood) will be assessed using the Brunel Mood Scale and exercise induced feeling inventory.
Baseline, 3-months, 6-months, 1-year follow-up
Change from baseline in executive function at 3-months
Time Frame: Baseline and 3-months
Change from baseline in executive function will be assessed using composite executive function score obtained from scores on Digit Span Backwards, Stroop, and Color Trails.
Baseline and 3-months
Change from baseline in executive function at 1-year follow-up
Time Frame: Baseline and 1-year
Change from baseline in executive function will be assessed using composite executive function score obtained from scores on Digit Span Backwards, Stroop, and Color Trails.
Baseline and 1-year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in BDNF at 6-months
Time Frame: Baseline and 6-months
BDNF levels (collected from saliva samples) at 6-months will be compared with baseline levels.
Baseline and 6-months
Change from baseline in MRI at 6-months
Time Frame: Baseline and 6-months
MRI scans collected at baseline and 6-months will be analyzed for volumetric changes.
Baseline and 6-months
Cognitive characteristics of sample pre- and post- intervention
Time Frame: Baseline and 6-months
The MoCA, ADAS-Cog word recall, complex figures, and controlled oral word association test will be used to characterize the sample based on cognitive function at pre- and post-intervention.
Baseline and 6-months
Assessment of exercise behavior during intervention
Time Frame: After each exercise session
Participants are asked to exercise 3-5x/week. After each exercise session subjects will record their exercise data (e.g., time, distance, power, heart rate, calories, points).
After each exercise session

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)

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

September 1, 2014

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

September 4, 2014

First Submitted That Met QC Criteria

September 9, 2014

First Posted (Estimate)

September 11, 2014

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS13083
  • R15AG042109-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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