The Aerobic & Cognitive Exercise Study

Study Overview
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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.

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

Conditions
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Mild Cognitive Impairment, Healthy

Intervention / Treatment
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* Behavioral: Cybercycle-Game
* Behavioral: Cybercyle-Tour
* Behavioral: Game Only


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in executive function at 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MCI, Exergaming, Cognition, Exercise, Older Adults