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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03032796

Acronym

BBT

Enrollment

Registered

2017-01-26

Start date

2017-01-31

Completion date

2020-03-31

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adults

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.

Interventions

BEHAVIORALBody-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.

BEHAVIORALBody 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

BEHAVIORALBrain 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.

BEHAVIORALExpectancy 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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

55 Years to 80 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
mCPT (Derived From Test of Variables of Attention (T.O.V.A.))	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

Secondary

Measure	Time frame	Description
Delayed Recognition Working Memory Task: Response Time Variability Prior to and 9-weeks After Baseline	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 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.

Other

Measure	Time frame	Description
Blood Pressure Measures	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)	Assessing a change in systolic & diastolic pressure following the intervention
Limit of Stability	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)	Assessing a change in balance following the intervention
EEG Functional Measure (Event-related Spectral Perturbation)	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)	Assessing a change in event-related spectral perturbation following the intervention
EEG Functional Measure (Long-range Coherence as Measured Via Phase Locking Values): Decibels Prior to and at 9 Weeks Post Baseline	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)	Assessing a change in coherence following the intervention. This measure assesses the synchronization of neural activity between frontal and posterior regions of the brain, looking to quantify how coherent these signals are. For example, if the activity at the front of the head shows greater synchrony with activity at the back of the head, than this measure of interest would show a greater amount of coherence. Coherence of this type is reported in the form of phase locking value, which tells us how consistently the timing of those rhythms stay aligned across many repetitions of the same event. PLV close to 1 (or 100%) → very consistent timing, almost perfectly locked together, whereas PLV close to 0 → timing is random, no consistent relationship. PLVs are typically reported in decibels to facilitate seeing subtle changes, compare across conditions, and stay consistent with other brainwave measures.

Countries

United States

Participant flow

Pre-assignment details

We were only able to enroll in 2 of the 4 arms for this study due to resource limitations for this study.

Participants by arm

Arm	Count
Body-Brain Trainer Body-Brain Trainer 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.	24
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 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.	25
Total	49

Baseline characteristics

Characteristic	Body-Brain Trainer	Expectancy Matched Control Group	Total
Age, Continuous	68.8 years STANDARD_DEVIATION 5.9	68.2 years STANDARD_DEVIATION 6.7	68.5 years STANDARD_DEVIATION 6.3
EEG	0.77 decibles STANDARD_DEVIATION 1.85	1.67 decibles STANDARD_DEVIATION 2.27	1.33 decibles STANDARD_DEVIATION 2.02
mCPT	72.5 milliseconds STANDARD_DEVIATION 39.7	52.2 milliseconds STANDARD_DEVIATION 31.2	62.2 milliseconds STANDARD_DEVIATION 35.5
Race and Ethnicity Not Collected	—	—	0 Participants
Region of Enrollment United States	24 participants	25 participants	49 participants
Sex: Female, Male Female	13 Participants	13 Participants	26 Participants
Sex: Female, Male Male	11 Participants	12 Participants	23 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	0 / 24	0 / 0	0 / 0	0 / 25
other Total, other adverse events	0 / 24	0 / 0	0 / 0	0 / 25
serious Total, serious adverse events	0 / 24	0 / 0	0 / 0	0 / 25