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Clinical Trials/NCT02237560
NCT02237560
Completed
Not Applicable

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

Union College, New York12 sites in 1 country111 target enrollmentSeptember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mild Cognitive Impairment
Sponsor
Union College, New York
Enrollment
111
Locations
12
Primary Endpoint
Change from baseline in executive function at 6-months
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2014
End Date
July 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Union College, New York
Responsible Party
Principal Investigator
Principal Investigator

Cay Anderson-Hanley, PhD

Associate Professor

Union College, New York

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Change from baseline in executive function at 6-months

Time Frame: 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 Outcomes

  • Change from baseline in executive function at 3-months(Baseline and 3-months)
  • Change in weight(Baseline, 3-months, 6-months, 1-year)
  • Change from baseline in executive function at 1-year follow-up(Baseline and 1-year)
  • Change in mood(Baseline, 3-months, 6-months, 1-year follow-up)

Study Sites (12)

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