Overview

This trial is active, not recruiting.

Conditions mild cognitive impairment, healthy
Treatments cybercycle-game, cybercyle-tour, game only
Sponsor Union College, New York
Collaborator National Institute on Aging (NIA)
Start date September 2014
End date June 2016
Trial size 111 participants
Trial identifier NCT02237560, HS13083, R15AG042109-01A1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Combined aerobic & cognitive exercise for 6 months, 3-5x/week.
cybercycle-game Expresso
Exercising on a virtual-reality enhanced stationary recumbent bicycle while playing interactive 3D video-game for 6 months, 3-5x/week.
(Active Comparator)
Aerobic exercise only for 6 months, 3-5x/week.
cybercyle-tour Expresso
Exercising on virtual-reality enhanced stationary recumbent bicycle and pedaling through interactive 3D scenic bike tours for 6 months, 3-5x/week.
(Active Comparator)
Cognitive exercise only 6 months, 3-5x/week.
game only Dragon Chase
While seated on a stationary recumbent seat play interactive 3D video-game for 6 months, 3-5x/week (no pedaling).

Primary Outcomes

Measure
Change from baseline in executive function at 6-months
time frame: Baseline and 6-months

Secondary Outcomes

Measure
Change in weight
time frame: Baseline, 3-months, 6-months, 1-year
Change in mood
time frame: 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 at 1-year follow-up
time frame: Baseline and 1-year

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

Official title The Cognitive Benefits of Interactive Mental and Physical Exercise for Older Adults at Risk for or With Mild Cognitive Impairment (MCI)
Principal investigator Cay Anderson-Hanley, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Union College, New York.