The Aerobic & Cognitive Exercise Study

Healthy Clinical Trial

— ACES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02237560
• Other study ID #: HS13083
• Secondary ID: R15AG042109-01A1
• Status: Completed
• Phase: N/A
• Start date: September 2014
• Est. completion date: July 2017

Study information

• Verified date: April 2018
• Source: Union College, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Healthy
• Mild Cognitive Impairment

Intervention

Behavioral:
• Cybercycle-Game
Exercising on a virtual-reality enhanced stationary recumbent bicycle while playing interactive 3D video-game for 6 months, 3-5x/week.
• Cybercyle-Tour
Exercising on virtual-reality enhanced stationary recumbent bicycle and pedaling through interactive 3D scenic bike tours for 6 months, 3-5x/week.
• Game Only
While seated on a stationary recumbent seat play interactive 3D video-game for 6 months, 3-5x/week (no pedaling).

Locations

Country	Name	City	State
United States	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	Glen Eddy	Niskayuna	New York
United States	Coburg Village	Rexford	New York
United States	Prestwick Chase	Saratoga Springs	New York
United States	Kingsway Parkland GardenApartments	Schenectady	New York
United States	Schaffer Heights	Schenectady	New York
United States	Sunnyview Rehabilitation Center	Schenectady	New York
United States	Beverwyck	Slingerlands	New York

Sponsors (2)

Lead Sponsor	Collaborator
Union College, New York	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in BDNF at 6-months	BDNF levels (collected from saliva samples) at 6-months will be compared with baseline levels.	Baseline and 6-months
Other	Change from baseline in MRI at 6-months	MRI scans collected at baseline and 6-months will be analyzed for volumetric changes.	Baseline and 6-months
Other	Cognitive characteristics of sample pre- and post- intervention	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.	Baseline and 6-months
Other	Assessment of exercise behavior during intervention	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).	After each exercise session
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

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