NCT02237560

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2014

Typical duration for not_applicable

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

May 3, 2018

Status Verified

April 1, 2018

Enrollment Period

2.8 years

First QC Date

September 4, 2014

Last Update Submit

April 30, 2018

Conditions

Keywords

MCIExergamingCognitionExerciseOlder Adults

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in weight

    Baseline, 3-months, 6-months, 1-year

  • Change in mood

    Baseline, 3-months, 6-months, 1-year follow-up

  • Change from baseline in executive function at 3-months

    Baseline and 3-months

  • Change from baseline in executive function at 1-year follow-up

    Baseline and 1-year

Other Outcomes (4)

  • Change from baseline in BDNF at 6-months

    Baseline and 6-months

  • Change from baseline in MRI at 6-months

    Baseline and 6-months

  • Cognitive characteristics of sample pre- and post- intervention

    Baseline and 6-months

  • +1 more other outcomes

Study Arms (3)

Cybercycle-Game

EXPERIMENTAL

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

Behavioral: Cybercycle-Game

Cybercyle-Tour

ACTIVE COMPARATOR

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

Behavioral: Cybercyle-Tour

Game Only

ACTIVE COMPARATOR

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

Behavioral: Game Only

Interventions

Cybercycle-GameBEHAVIORAL

Exercising on a virtual-reality enhanced stationary recumbent bicycle while playing interactive 3D video-game for 6 months, 3-5x/week.

Also known as: Expresso, Dragon Chase
Cybercycle-Game
Cybercyle-TourBEHAVIORAL

Exercising on virtual-reality enhanced stationary recumbent bicycle and pedaling through interactive 3D scenic bike tours for 6 months, 3-5x/week.

Also known as: Expresso
Cybercyle-Tour
Game OnlyBEHAVIORAL

While seated on a stationary recumbent seat play interactive 3D video-game for 6 months, 3-5x/week (no pedaling).

Also known as: Dragon Chase
Game Only

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Albany Medical Center

Albany, New York, 12208, United States

Location

Sidney Albert Albany Jewish Community Center

Albany, New York, 12208, United States

Location

Stratton VA Medical Center

Albany, New York, 12208, United States

Location

Hawthorne Ridge

East Greenbush, New York, 12061, United States

Location

Guilderland YMCA

Guilderland, New York, 12084, United States

Location

Glen Eddy

Niskayuna, New York, 12309, United States

Location

Coburg Village

Rexford, New York, 12148, United States

Location

Prestwick Chase

Saratoga Springs, New York, 12866, United States

Location

Kingsway Parkland GardenApartments

Schenectady, New York, 12304, United States

Location

Schaffer Heights

Schenectady, New York, 12308, United States

Location

Sunnyview Rehabilitation Center

Schenectady, New York, 12308, United States

Location

Beverwyck

Slingerlands, New York, 12159, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cognitive DysfunctionMotor Activity

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBehavior

Study Officials

  • Cay Anderson-Hanley, PhD

    Union College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 4, 2014

First Posted

September 11, 2014

Study Start

September 1, 2014

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

May 3, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations