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Completed

NCT Number: NCT02237560

The Aerobic & Cognitive Exercise Study

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.

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Key information

Conditions

Mild Cognitive Impairment Behavior Cognition Disorders Cognitive Dysfunction Healthy Mental Disorders Motor Activity Neurocognitive Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Albany Medical Center, Albany, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cybercycle-Game

Behavioral

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

Cybercyle-Tour

Behavioral

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

Game Only

Behavioral

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

Other names: Dragon Chase

Primary outcomes

  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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Union College, New York

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: ACES

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Sep 11, 2014
Registry last updated
May 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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