Clinical trial NCT02237560: The Aerobic & Cognitive Exercise Study
Official title: The Cognitive Benefits of Interactive Mental and Physical Exercise for Older Adults at Risk for or With Mild Cognitive Impairment (MCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Healthy
Keywords: MCI
Exergaming
Cognition
Exercise
Older Adults
Lead sponsor: Union College, New York
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2014-09-11
Enrollment: 111
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in executive function at 6-months
timeFrame: Baseline and 6-months
Secondary outcomes:
measure: Change in weight
timeFrame: Baseline, 3-months, 6-months, 1-year
measure: Change in mood
timeFrame: Baseline, 3-months, 6-months, 1-year follow-up
measure: Change from baseline in executive function at 3-months
timeFrame: Baseline and 3-months
measure: Change from baseline in executive function at 1-year follow-up
timeFrame: Baseline and 1-year
Other outcomes:
measure: Change from baseline in BDNF at 6-months
timeFrame: Baseline and 6-months
measure: Change from baseline in MRI at 6-months
timeFrame: Baseline and 6-months
measure: Cognitive characteristics of sample pre- and post- intervention
timeFrame: Baseline and 6-months
measure: Assessment of exercise behavior during intervention
timeFrame: After each exercise session
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
city: Albany
country: United States
facility: Sidney Albert Albany Jewish Community Center
state: New York
city: Albany
country: United States
facility: Stratton VA Medical Center
state: New York
city: East Greenbush
country: United States
facility: Hawthorne Ridge
state: New York
city: Guilderland
country: United States
facility: Guilderland YMCA
state: New York
city: Niskayuna
country: United States
facility: Glen Eddy
state: New York
city: Rexford
country: United States
facility: Coburg Village
state: New York
city: Saratoga Springs
country: United States
facility: Prestwick Chase
state: New York
city: Schenectady
country: United States
facility: Kingsway Parkland GardenApartments
state: New York
city: Schenectady
country: United States
facility: Schaffer Heights
state: New York
city: Schenectady
country: United States
facility: Sunnyview Rehabilitation Center
state: New York
city: Slingerlands
country: United States
facility: Beverwyck
state: New York
Study officials:
affiliation: Union College
name: Cay Anderson-Hanley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson-Hanley C, Barcelos NM, Zimmerman EA, Gillen RW, Dunnam M, Cohen BD, Yerokhin V, Miller KE, Hayes DJ, Arciero PJ, Maloney M, Kramer AF. The Aerobic and Cognitive Exercise Study (ACES) for Community-Dwelling Older Adults With or At-Risk for Mild Cognitive Impairment (MCI): Neuropsychological, Neurobiological and Neuroimaging Outcomes of a Randomized Clinical Trial. Front Aging Neurosci. 2018 May 4;10:76. doi: 10.3389/fnagi.2018.00076. eCollection 2018.