Healthy, Mild Cognitive Impairment
Conditions
Keywords
MCI, Exergaming, Cognition, Exercise, Older Adults
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.
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.
Interventions
BEHAVIORALCybercycle-Game
Exercising on a virtual-reality enhanced stationary recumbent bicycle while playing interactive 3D video-game for 6 months, 3-5x/week.
BEHAVIORALCybercyle-Tour
Exercising on virtual-reality enhanced stationary recumbent bicycle and pedaling through interactive 3D scenic bike tours for 6 months, 3-5x/week.
BEHAVIORALGame Only
While seated on a stationary recumbent seat play interactive 3D video-game for 6 months, 3-5x/week (no pedaling).
Sponsors
National Institute on Aging (NIA)
Union College, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in executive function at 6-months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in weight | 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 |
| Change in mood | 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. |
| Change from baseline in executive function at 3-months | 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. |
| Change from baseline in executive function at 1-year follow-up | 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in MRI at 6-months | Baseline and 6-months | MRI scans collected at baseline and 6-months will be analyzed for volumetric changes. |
| Cognitive characteristics of sample pre- and post- intervention | 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. |
| Assessment of exercise behavior during intervention | 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). |
| Change from baseline in BDNF at 6-months | Baseline and 6-months | BDNF levels (collected from saliva samples) at 6-months will be compared with baseline levels. |
Countries
United States
Outcome results
None listed