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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

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.

Condition or disease Intervention/treatment Phase
Healthy Adults Behavioral: Body-Brain Trainer Behavioral: Body Trainer Behavioral: Brain Trainer Behavioral: Expectancy Matched Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Characterizing the Synergistic Effects of Physical and Cognitive Training on Attention and Working Memory
Study Start Date : January 2017
Actual Primary Completion Date : March 2020
Actual Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: BBT
Body-Brain Trainer
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.

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.
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

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).
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.

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
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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

  2. VO2max [ Time Frame: Before and following the intervention (1 week after intervention use has ended) ]
    Assessing a change in VO2max following the intervention

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032796


Locations
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United States, California
UCSF Neuroscape
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Joaquin A. Anguera, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03032796    
Other Study ID Numbers: 1R21MH110743-01
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No