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The Aerobic & Cognitive Exercise Study (ACES)

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: NCT02237560
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : May 3, 2018
Sponsor:
Collaborator:
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:
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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Healthy Behavioral: Cybercycle-Game Behavioral: Cybercyle-Tour Behavioral: Game Only Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Cognitive Benefits of Interactive Mental and Physical Exercise for Older Adults at Risk for or With Mild Cognitive Impairment (MCI)
Study Start Date : September 2014
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: Dragon Chase


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.

  4. 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).


Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • 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
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): NCT02237560


Locations
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United States, New York
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
Albany, New York, United States, 12208
Hawthorne Ridge
East Greenbush, New York, United States, 12061
Guilderland YMCA
Guilderland, New York, United States, 12084
Glen Eddy
Niskayuna, New York, United States, 12309
Coburg Village
Rexford, New York, United States, 12148
Prestwick Chase
Saratoga Springs, New York, United States, 12866
Kingsway Parkland GardenApartments
Schenectady, New York, United States, 12304
Schaffer Heights
Schenectady, New York, United States, 12308
Sunnyview Rehabilitation Center
Schenectady, New York, United States, 12308
Beverwyck
Slingerlands, New York, United States, 12159
Sponsors and Collaborators
Union College, New York
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Cay Anderson-Hanley, PhD, Associate Professor, Union College, New York
ClinicalTrials.gov Identifier: NCT02237560    
Other Study ID Numbers: HS13083
R15AG042109-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: May 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Cay Anderson-Hanley, PhD, Union College, New York:
MCI
Exergaming
Cognition
Exercise
Older Adults
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Camphor
Salicylates
Methyl salicylate
Menthol
Anti-Infective Agents, Local
Anti-Infective Agents
Antipruritics
Dermatologic Agents
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action