The Aerobic & Cognitive Exercise Study

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment; Healthy
• Interventions: Behavioral: Cybercycle-Game; Behavioral: Game Only; Behavioral: Cybercyle-Tour

• Registration Number: NCT02237560
• Lead Sponsor: Union College, New York

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-09
• Study First Posted: 2014-09-11
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cybercycle-Game	Cybercycle-Game	Combined aerobic \& cognitive exercise for 6 months, 3-5x/week.
Game Only	Game Only	Cognitive exercise only 6 months, 3-5x/week.
Cybercyle-Tour	Cybercyle-Tour	Aerobic exercise only for 6 months, 3-5x/week.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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.
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.

Trial Locations

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

Hawthorne Ridge; 🇺🇸 East Greenbush, New York, United States

Guilderland YMCA; 🇺🇸 Guilderland, New York, United States

Prestwick Chase; 🇺🇸 Saratoga Springs, New York, United States

Glen Eddy; 🇺🇸 Niskayuna, New York, United States

Sunnyview Rehabilitation Center; 🇺🇸 Schenectady, New York, United States

Coburg Village; 🇺🇸 Rexford, New York, United States

Schaffer Heights; 🇺🇸 Schenectady, New York, United States

Kingsway Parkland GardenApartments; 🇺🇸 Schenectady, New York, United States

Beverwyck; 🇺🇸 Slingerlands, New York, United States