The Aerobic & Cognitive Exercise Study

Union College, New York111 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

111

Conditions

Mild Cognitive Impairment Healthy

Interventions

Cybercycle-GameBEHAVIORAL

Exercising on a virtual-reality enhanced stationary recumbent bicycle while playing interactive 3D video-game for 6 months, 3-5x/week.

Cybercyle-TourBEHAVIORAL

Exercising on virtual-reality enhanced stationary recumbent bicycle and pedaling through interactive 3D scenic bike tours for 6 months, 3-5x/week.

Game OnlyBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (12)

Albany Medical Center

Albany, New York, United States

Sidney Albert Albany Jewish Community Center

Albany, New York, United States

Stratton VA Medical Center

Albany, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 6-months

Secondary Outcomes

Change in weight

Weight and other physiological factors will be assessed at baseline, 3-months, 6-months, and 1-year follow-up

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Baseline and 1-year

Data from ClinicalTrials.gov

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