Healthy AdultsBBTNCT03032796
Characterizing the Synergistic Effects of Physical and Cognitive Training on Attention and Working Memory
A study testing Body-Brain Trainer, Body Trainer and Brain Trainer in people with Healthy Adults, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Body-Brain Trainer, Body Trainer and Brain Trainer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- cardiac problems
- bypass surgery
- pacemaker or heart valve replacement
- stroke
- respiratory conditions
- head trauma with loss of consciousness for less than a few minutes
Show all 22Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy Adults
- Being tested
- Body-Brain Trainer, Body Trainer, Brain Trainer, Expectancy Matched Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body-Brain TrainerBehavioural
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.
Body TrainerBehavioural
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
Brain TrainerBehavioural
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.
Expectancy Matched ControlBehavioural
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 group | Role | What they receive |
|---|---|---|
| BBT | Experimental | Body-Brain Trainer Receives: Behavioral: Body-Brain Trainer |
| Body Trainer | Active comparator | 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. Receives: Behavioral: Body Trainer |
| Brain Trainer | Active comparator | 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). Receives: Behavioral: Brain Trainer |
| Expectancy Matched Control Group | Placebo comparator | 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 Receives: Behavioral: Expectancy Matched Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
mCPT (Derived From Test of Variables of Attention (T.O.V.A.))
A change from baseline regarding measurement of sustained attention and impulsivity abilities
Measured: At baseline and following the intervention (these data were collected no more than 1 week after intervention period ended, thus approximately 9 weeks after baseline data were collected)
Secondary outcomes (1)
Delayed Recognition Working Memory Task: Response Time Variability Prior to and 9-weeks After Baseline
A change from baseline regarding measurement of working memory abilities in the presence of interference. This task involved memorizing a face for set amount of time, followed by a delay period (during which participants were exposed to different types of distracting images), followed by the presentation of an image that participants are cued to respond whether or not this image matches the initial one presented. Here we examined a version of response time variance derived from exGaussain Statistics called tau, that is a measure of response time variance that considers the tails on a Gaussian distribution with respect to response time variability. This analysis allows one to see how variant one's performance could be on trials that fall outside of their mean performance distribution.
Measured: At baseline and following the intervention (these data were collected no more than 1 week after intervention period ended, thus approximately 9 weeks after baseline data were collected)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joaquin A. Anguera, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032796
- Sponsor's protocol ID
- 1R21MH110743-01
- Acronym
- BBT
- Status last verified
- Sep 2025
- First submitted
- 12 Jan 2017
- Last updated
- 15 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing the Synergistic Effects of Physical and Cognitive Training on Attention and Working Memory
- ClinicalTrials.gov ID
- NCT03032796
- Acronym / sponsor ID
- BBT / 1R21MH110743-01
- Conditions
- Healthy Adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Posted 15 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BBT | Experimental | Behavioral: Body-Brain TrainerBody-Brain Trainer |
| Body Trainer | Active comparator | Behavioral: Body TrainerParticipants 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. |
| Brain Trainer | Active comparator | Behavioral: Brain TrainerThe "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). |
| Expectancy Matched Control Group | Placebo comparator | Behavioral: Expectancy Matched ControlThe 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 |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (22 listed)
- cardiac problems
- bypass surgery
- pacemaker or heart valve replacement
- stroke
- respiratory conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Body-Brain TrainerA 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. | Behavioural | BBT |
| Body TrainerA 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 | Behavioural | Body Trainer |
| Brain TrainerThe "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. | Behavioural | Brain Trainer |
| Expectancy Matched ControlThe 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. | Behavioural | Expectancy Matched Control Group |
Primary outcome
mCPT (Derived From Test of Variables of Attention (T.O.V.A.))
Time frame: At baseline and following the intervention (these data were collected no more than 1 week after intervention period ended, thus approximately 9 weeks after baseline data were collected)
A change from baseline regarding measurement of sustained attention and impulsivity abilities
1 secondary outcome
Delayed Recognition Working Memory Task: Response Time Variability Prior to and 9-weeks After Baseline
Time frame: At baseline and following the intervention (these data were collected no more than 1 week after intervention period ended, thus approximately 9 weeks after baseline data were collected)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joaquin A. Anguera, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body-Brain Trainer, Body Trainer and Brain Trainer in people with Healthy Adults, run by University of California, San Francisco at 1 site 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 5 inclusion and 22 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 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 15 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
mCPT (Derived From Test of Variables of Attention (T.O.V.A.)) (time frame: At baseline and following the intervention (these data were collected no more than 1 week after intervention period ended, thus approximately 9 weeks after baseline data were collected)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2025.