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Mild Cognitive ImpairmentACESNCT02237560

The Aerobic & Cognitive Exercise Study

A study testing Cybercycle-Game, Cybercyle-Tour and Game Only in people with Mild Cognitive Impairment and Healthy, run by Union College, New York at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Mild Cognitive Impairment, Healthy
What is being tested?
Cybercycle-Game, Cybercyle-Tour and Game Only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
12 sitesUnited States
Study dates
Sep 2014to Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Albany Medical Center

    Albany, New York, 12208

  • Sidney Albert Albany Jewish Community Center

    Albany, New York, 12208

  • Stratton VA Medical Center

    Albany, New York, 12208

  • Hawthorne Ridge

    East Greenbush, New York, 12061

  • Guilderland YMCA

    Guilderland, New York, 12084

  • Glen Eddy

    Niskayuna, New York, 12309

  • Coburg Village

    Rexford, New York, 12148

  • Prestwick Chase

    Saratoga Springs, New York, 12866

  • Kingsway Parkland GardenApartments

    Schenectady, New York, 12304

  • Schaffer Heights

    Schenectady, New York, 12308

  • Sunnyview Rehabilitation Center

    Schenectady, New York, 12308

  • Beverwyck

    Slingerlands, New York, 12159

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Cybercycle-Game, Cybercyle-Tour, Game Only
Keywords
MCI, Exergaming, Cognition, Exercise, Older Adults
Medical subject headings
Cognitive Dysfunction, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cybercycle-GameBehavioural

    Also called Expresso, Dragon Chase

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

  • Cybercyle-TourBehavioural

    Also called Expresso

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

  • Game OnlyBehavioural

    Also called Dragon Chase

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

Study groups in NCT02237560
Study groupRoleWhat they receive
Cybercycle-GameExperimentalCombined aerobic \& cognitive exercise for 6 months, 3-5x/week.
Receives: Behavioral: Cybercycle-Game
Cybercyle-TourActive comparatorAerobic exercise only for 6 months, 3-5x/week.
Receives: Behavioral: Cybercyle-Tour
Game OnlyActive comparatorCognitive exercise only 6 months, 3-5x/week.
Receives: Behavioral: Game Only

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and 6-months

Secondary outcomes (4)

  1. Change in weight

    Weight and other physiological factors will be assessed at baseline, 3-months, 6-months, and 1-year follow-up

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

  2. Change in mood

    Behavioral outcomes (e.g., mood) will be assessed using the Brunel Mood Scale and exercise induced feeling inventory.

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

  3. 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.

    Measured: Baseline and 3-months

  4. 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.

    Measured: Baseline and 1-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionJul 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02237560
Sponsor's protocol ID
HS13083
Other IDs
R15AG042109-01A1
Acronym
ACES
Status last verified
Apr 2018
First submitted
4 Sep 2014
Last updated
3 May 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 29780318

Questions about this trial

What is this clinical trial studying?

A study testing Cybercycle-Game, Cybercyle-Tour and Game Only in people with Mild Cognitive Impairment and Healthy, run by Union College, New York at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in executive function at 6-months (time frame: Baseline and 6-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02237560, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2018.

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The Aerobic & Cognitive Exercise Study (NCT02237560) | AzTrials