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Characterizing the Synergistic Effects of Physical and Cognitive Training on Attention and Working Memory (BBT)

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ClinicalTrials.gov Identifier: NCT03032796
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE January 12, 2017
First Posted Date  ICMJE January 26, 2017
Last Update Posted Date July 1, 2020
Study Start Date  ICMJE January 2017
Actual Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
Test of Variables of Attention (T.O.V.A.) [ Time Frame: At baseline and following the intervention (1 week after intervention use has ended) ]
A change from baseline regarding measurement of sustained attention and impulsivity abilities
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
Delayed Recognition Working Memory Task [ Time Frame: At baseline and following the intervention (1 week after intervention use has ended) ]
A change from baseline regarding measurement of working memory abilities in the presence of interference
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 23, 2017)
  • Blood Pressure measures [ Time Frame: Before and following the intervention (1 week after intervention use has ended) ]
    Assessing a change in systolic & diastolic pressure following the intervention
  • VO2max [ Time Frame: Before and following the intervention (1 week after intervention use has ended) ]
    Assessing a change in VO2max following the intervention
  • MRI Structural measurement [ Time Frame: Before and following the intervention (1 week after intervention use has ended) ]
    Assessing a change in structural profiles following the intervention
  • MRI functional activity [ Time Frame: Before and following the intervention (1 week after intervention use has ended) ]
    Assessing a change in functional activation profiles following the intervention
  • EEG functional measures (event-related potentials) [ Time Frame: Before and following the intervention (1 week after intervention use has ended) ]
    Assessing a change in event-related potentials following the intervention
  • EEG functional measure (event-related spectral perturbation) [ Time Frame: Before and following the intervention (1 week after intervention use has ended) ]
    Assessing a change in event-related spectral perturbation following the intervention
  • EEG functional measure (long-range coherence) [ Time Frame: Before and following the intervention (1 week after intervention use has ended) ]
    Assessing a change in coherence following the intervention
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Characterizing the Synergistic Effects of Physical and Cognitive Training on Attention and Working Memory
Official Title  ICMJE Characterizing the Synergistic Effects of Physical and Cognitive Training on Attention and Working Memory
Brief Summary The primary goal of this project is to evidence potential synergistic benefits on cognitive control processes using a video game ("Body-Brain Trainer", or BBT) that integrates cognitive and physical challenges in a complimentary fashion. Healthy adults will be recruited for a longitudinal experiment and randomly assigned to one of four study groups to mechanistically tease apart the possible presence of any synergistic effects on cognitive abilities through the combination of cognitive & physical challenges.
Detailed Description Cognitive control functions (e.g. attention, working memory, goal-management) dictate our ability to learn and accomplish selected behavioral goals, with deficiencies in these processes found in a range of mental illnesses. The primary goal of this project is to evidence potential synergistic benefits on cognitive control processes using a video game ("Body-Brain Trainer", or BBT) that integrates cognitive and physical challenges in a complimentary fashion. Healthy adults will be recruited for a longitudinal experiment and randomly assigned to one of four study groups: 1) BBT, 2) "Brain Training" (BBT played with a gamepad controller), 3) "Body Training" (BBT without any cognitive demands), and 4) an expectancy matched placebo control group. Individuals will engage in eight weeks of training within our Neuroscape Laboratory, with pre- and post-training assessments evaluating physical, cognitive, and neural measures. The completion of this project will result in a more sophisticated understanding of how the integration of cognitive and physical training potentially impacts cognitive control processes, setting the stage for more effective interventions for mental illness and learning-related impairments.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Adults
Intervention  ICMJE
  • Behavioral: Body-Brain Trainer
    A novel video game-based intervention that incorporates i) adaptive algorithms critical for cognitive training, ii) physiological measures such as heart rate into the core game mechanics, and iii) motion capture technology to incorporate whole-body kinematics into game play. This group will train for 36 minutes per day, 3 days a week for 8 weeks.
  • Behavioral: Body Trainer
    A novel video game-based intervention that incorporates physiological measures such as heart rate into the core game mechanics, with motion capture technology to incorporate whole-body kinematics into game play. This group will train for 36 minutes per day, 3 days a week for 8 weeks. The "Body Trainer" group will train using closed-loop adaptive algorithms to challenge physical performance as guided by heart rate, such that the amount of movement needed to respond on each task will dynamically change depending upon the participant being below/above a predetermined derived level of exertion. During "Body Training", participants will only perform a basic reaction task in each level/module to ensure only the most minimal cognitive challenge is present
  • Behavioral: Brain Trainer
    The "Brain Trainer" group will train using the aforementioned closed-loop adaptive algorithms to challenge cognitive performance, except while sitting down and playing with an Xbox control pad (thus removing all physical training aspects). This group will train for 36 minutes per day, 3 days a week for 8 weeks.
  • Behavioral: Expectancy Matched Control
    The placebo-matched control group will engage in a battery of three apps (playing each app 10 minutes per day, 5 days a week for 8 weeks completed in the laboratory that we believe will have no significant impact on the cognitive or physical fitness measures we are assessing: i) an app with 100 different logic games of varying difficulty and length, ii) a language-learning app with 10 language options, and iii) an app that offers a guided Tai Chi program. We have pre-determined that this approach generates matched expectancy compared to our training groups: we asked 100 naïve individuals to predict how they would expect to improve performance on our outcome measures after training on one of these platforms, revealing that placebo training generates equivalent expectations of improvement across each outcome measure as the BBT group.
Study Arms  ICMJE
  • Experimental: BBT
    Body-Brain Trainer
    Intervention: Behavioral: Body-Brain Trainer
  • Active Comparator: Body Trainer
    Participants will only perform a basic reaction task in each level/module to ensure only the most minimal cognitive challenge is present, while completing all of the physical aspects of BBT. Thus this will be a physical training protocol.
    Intervention: Behavioral: Body Trainer
  • Active Comparator: Brain Trainer
    The "Brain Trainer" group will train using the same platform as the BBT group, except while sitting down and playing with an Xbox control pad (thus removing all physical training aspects).
    Intervention: Behavioral: Brain Trainer
  • Placebo Comparator: Expectancy Matched Control Group
    The placebo-matched control group will engage in a battery of three apps in the laboratory that we believe will have no significant impact on cognition
    Intervention: Behavioral: Expectancy Matched Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2020)
49
Original Estimated Enrollment  ICMJE
 (submitted: January 23, 2017)
100
Actual Study Completion Date  ICMJE March 2020
Actual Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Can walk briskly for at least 15 minutes continuously without stopping
  • Can stand up from a chair without using your hands
  • Available to come 3x/week to our UCSF Mission Bay laboratory for 8 weeks
  • Willing and able to undergo MRI, EEG procedures
  • English fluency

Exclusion Criteria:

  • cardiac problems
  • bypass surgery
  • pacemaker or heart valve replacement
  • stroke
  • respiratory conditions
  • head trauma with loss of consciousness for less than a few minutes
  • severe head trauma with loss of consciousness for more than a few minutes
  • high/low blood pressure
  • kidney failure
  • electroconvulsive therapy (ECT)
  • seizures
  • implanted electrodes
  • cancer/chemotherapy/radiation
  • diabetes
  • irritable bowel syndrome
  • back problems
  • claustrophobia
  • Having been diagnosed with a psychiatric or neurological disorder
  • Use of an assistive device (e.g., cane or walker) at any time to assist with ambulation
  • Joint problems causing significant pain upon movement
  • Heart Disease or Cardiovascular Disease
  • Respiratory Disease (Lung Disease)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03032796
Other Study ID Numbers  ICMJE 1R21MH110743-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joaquin A. Anguera, PhD University of California, San Francisco
PRS Account University of California, San Francisco
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP