NCT03032796

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

January 12, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 26, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

September 15, 2025

Completed
Last Updated

September 15, 2025

Status Verified

September 1, 2025

Enrollment Period

3.2 years

First QC Date

January 12, 2017

Results QC Date

December 1, 2023

Last Update Submit

September 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • mCPT (Derived From Test of Variables of Attention (T.O.V.A.))

    A change from baseline regarding measurement of sustained attention and impulsivity abilities

    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

    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)

Other Outcomes (4)

  • 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)

  • 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)

  • 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)

  • +1 more other outcomes

Study Arms (4)

BBT

EXPERIMENTAL

Body-Brain Trainer

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.

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).

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

Behavioral: Expectancy Matched Control

Interventions

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.

BBT
Body TrainerBEHAVIORAL

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

Body Trainer
Brain TrainerBEHAVIORAL

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.

Brain Trainer

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.

Expectancy Matched Control Group

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCSF Neuroscape

San Francisco, California, 94158, United States

Location

Limitations and Caveats

We were not able to collect all four arms as originally intended due to logistical and resource issues.

Results Point of Contact

Title
Joaquin A. Anguera, Associate Professor, Neuroscape | UCSF
Organization
University of California San Francisco

Study Officials

  • Joaquin A. Anguera, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2017

First Posted

January 26, 2017

Study Start

January 1, 2017

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

September 15, 2025

Results First Posted

September 15, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations