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The Aerobic & Cognitive Exercise Study (ACES)

Primary Purpose

Mild Cognitive Impairment, Healthy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cybercycle-Game
Cybercyle-Tour
Game Only
Sponsored by
Union College, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Cognitive Impairment focused on measuring MCI, Exergaming, Cognition, Exercise, Older Adults

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Albany Medical Center
  • Sidney Albert Albany Jewish Community Center
  • Stratton VA Medical Center
  • Hawthorne Ridge
  • Guilderland YMCA
  • Glen Eddy
  • Coburg Village
  • Prestwick Chase
  • Kingsway Parkland GardenApartments
  • Schaffer Heights
  • Sunnyview Rehabilitation Center
  • Beverwyck

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Cybercycle-Game

Cybercyle-Tour

Game Only

Arm Description

Combined aerobic & cognitive exercise for 6 months, 3-5x/week.

Aerobic exercise only for 6 months, 3-5x/week.

Cognitive exercise only 6 months, 3-5x/week.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in weight
Weight and other physiological factors will be assessed at baseline, 3-months, 6-months, and 1-year follow-up
Change in mood
Behavioral outcomes (e.g., mood) will be assessed using the Brunel Mood Scale and exercise induced feeling inventory.
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.
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.

Full Information

First Posted
September 4, 2014
Last Updated
April 30, 2018
Sponsor
Union College, New York
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT02237560
Brief Title
The Aerobic & Cognitive Exercise Study
Acronym
ACES
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Union College, New York
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Healthy
Keywords
MCI, Exergaming, Cognition, Exercise, Older Adults

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cybercycle-Game
Arm Type
Experimental
Arm Description
Combined aerobic & cognitive exercise for 6 months, 3-5x/week.
Arm Title
Cybercyle-Tour
Arm Type
Active Comparator
Arm Description
Aerobic exercise only for 6 months, 3-5x/week.
Arm Title
Game Only
Arm Type
Active Comparator
Arm Description
Cognitive exercise only 6 months, 3-5x/week.
Intervention Type
Behavioral
Intervention Name(s)
Cybercycle-Game
Other Intervention Name(s)
Expresso, Dragon Chase
Intervention Description
Exercising on a virtual-reality enhanced stationary recumbent bicycle while playing interactive 3D video-game for 6 months, 3-5x/week.
Intervention Type
Behavioral
Intervention Name(s)
Cybercyle-Tour
Other Intervention Name(s)
Expresso
Intervention Description
Exercising on virtual-reality enhanced stationary recumbent bicycle and pedaling through interactive 3D scenic bike tours for 6 months, 3-5x/week.
Intervention Type
Behavioral
Intervention Name(s)
Game Only
Other Intervention Name(s)
Dragon Chase
Intervention Description
While seated on a stationary recumbent seat play interactive 3D video-game for 6 months, 3-5x/week (no pedaling).
Primary Outcome Measure Information:
Title
Change from baseline in executive function at 6-months
Description
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 Outcome Measure Information:
Title
Change in weight
Description
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
Title
Change in mood
Description
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
Title
Change from baseline in executive function at 3-months
Description
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
Title
Change from baseline in executive function at 1-year follow-up
Description
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
Other Pre-specified Outcome Measures:
Title
Change from baseline in BDNF at 6-months
Description
BDNF levels (collected from saliva samples) at 6-months will be compared with baseline levels.
Time Frame
Baseline and 6-months
Title
Change from baseline in MRI at 6-months
Description
MRI scans collected at baseline and 6-months will be analyzed for volumetric changes.
Time Frame
Baseline and 6-months
Title
Cognitive characteristics of sample pre- and post- intervention
Description
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.
Time Frame
Baseline and 6-months
Title
Assessment of exercise behavior during intervention
Description
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).
Time Frame
After each exercise session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cay Anderson-Hanley, PhD
Organizational Affiliation
Union College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Sidney Albert Albany Jewish Community Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Stratton VA Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Hawthorne Ridge
City
East Greenbush
State/Province
New York
ZIP/Postal Code
12061
Country
United States
Facility Name
Guilderland YMCA
City
Guilderland
State/Province
New York
ZIP/Postal Code
12084
Country
United States
Facility Name
Glen Eddy
City
Niskayuna
State/Province
New York
ZIP/Postal Code
12309
Country
United States
Facility Name
Coburg Village
City
Rexford
State/Province
New York
ZIP/Postal Code
12148
Country
United States
Facility Name
Prestwick Chase
City
Saratoga Springs
State/Province
New York
ZIP/Postal Code
12866
Country
United States
Facility Name
Kingsway Parkland GardenApartments
City
Schenectady
State/Province
New York
ZIP/Postal Code
12304
Country
United States
Facility Name
Schaffer Heights
City
Schenectady
State/Province
New York
ZIP/Postal Code
12308
Country
United States
Facility Name
Sunnyview Rehabilitation Center
City
Schenectady
State/Province
New York
ZIP/Postal Code
12308
Country
United States
Facility Name
Beverwyck
City
Slingerlands
State/Province
New York
ZIP/Postal Code
12159
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29780318
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.
Results Reference
derived

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The Aerobic & Cognitive Exercise Study

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