Trial Outcomes & Findings for Characterizing the Synergistic Effects of Physical and Cognitive Training on Attention and Working Memory (NCT NCT03032796)
NCT ID: NCT03032796
Last Updated: 2025-09-15
Results Overview
A change from baseline regarding measurement of sustained attention and impulsivity abilities
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
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 posted on
2025-09-15
Participant Flow
We were only able to enroll in 2 of the 4 arms for this study due to resource limitations for this study.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
|
Overall Study
COMPLETED
|
24
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Body-Brain Trainer
n=24 Participants
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.
|
Expectancy Matched Control Group
n=25 Participants
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.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.8 years
STANDARD_DEVIATION 5.9 • n=24 Participants
|
68.2 years
STANDARD_DEVIATION 6.7 • n=25 Participants
|
68.5 years
STANDARD_DEVIATION 6.3 • n=49 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=24 Participants
|
13 Participants
n=25 Participants
|
26 Participants
n=49 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=24 Participants
|
12 Participants
n=25 Participants
|
23 Participants
n=49 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
24 participants
n=24 Participants
|
25 participants
n=25 Participants
|
49 participants
n=49 Participants
|
|
mCPT
|
72.5 milliseconds
STANDARD_DEVIATION 39.7 • n=24 Participants
|
52.2 milliseconds
STANDARD_DEVIATION 31.2 • n=25 Participants
|
62.2 milliseconds
STANDARD_DEVIATION 35.5 • n=49 Participants
|
|
EEG
|
0.77 decibles
STANDARD_DEVIATION 1.85 • n=24 Participants
|
1.67 decibles
STANDARD_DEVIATION 2.27 • n=25 Participants
|
1.33 decibles
STANDARD_DEVIATION 2.02 • n=49 Participants
|
PRIMARY outcome
Timeframe: 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)Population: Due to logistical/practical consideration surrounding funding for this project, we were forced to only collect data for 2 gropus
A change from baseline regarding measurement of sustained attention and impulsivity abilities
Outcome measures
| Measure |
BBT: Body-Brain Trainer
n=24 Participants
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.
|
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.
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
|
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).
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.
|
Expectancy Matched Control Group
n=25 Participants
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.
|
|---|---|---|---|---|
|
mCPT (Derived From Test of Variables of Attention (T.O.V.A.))
|
72.5 milliseconds
Standard Deviation 39.7
|
—
|
—
|
52.2 milliseconds
Standard Deviation 31.2
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
BBT: Body-Brain Trainer
n=24 Participants
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.
|
Body Trainer
n=25 Participants
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.
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
|
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).
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.
|
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.
|
|---|---|---|---|---|
|
Delayed Recognition Working Memory Task: Response Time Variability Prior to and 9-weeks After Baseline
|
29.7 msec
Standard Deviation 14.1
|
24.1 msec
Standard Deviation 10.0
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
BBT: Body-Brain Trainer
n=24 Participants
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.
|
Body Trainer
n=25 Participants
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.
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
|
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).
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.
|
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.
|
|---|---|---|---|---|
|
Blood Pressure Measures
|
78.72 mmHG
Standard Deviation 5.25
|
76.23 mmHG
Standard Deviation 5.91
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
BBT: Body-Brain Trainer
n=24 Participants
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.
|
Body Trainer
n=25 Participants
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.
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
|
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).
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.
|
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.
|
|---|---|---|---|---|
|
Limit of Stability
|
3.88 meters/sec
Standard Deviation 1.34
|
4.29 meters/sec
Standard Deviation 1.26
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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
Outcome measures
| Measure |
BBT: Body-Brain Trainer
n=24 Participants
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.
|
Body Trainer
n=25 Participants
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.
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
|
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).
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.
|
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.
|
|---|---|---|---|---|
|
EEG Functional Measure (Event-related Spectral Perturbation)
|
.77 dB (decibles)
Standard Deviation 1.85
|
1.67 dB (decibles)
Standard Deviation 2.27
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
BBT: Body-Brain Trainer
n=24 Participants
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.
|
Body Trainer
n=25 Participants
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.
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
|
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).
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.
|
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.
|
|---|---|---|---|---|
|
EEG Functional Measure (Long-range Coherence as Measured Via Phase Locking Values): Decibels Prior to and at 9 Weeks Post Baseline
|
.24 Decibels
Standard Deviation .09
|
.28 Decibels
Standard Deviation .09
|
—
|
—
|
Adverse Events
BBT - Body-Brain Trainer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Body Trainer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Brain Trainer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Expectancy Matched Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Joaquin A. Anguera, Associate Professor, Neuroscape | UCSF
University of California San Francisco
Phone: 415-502-7322
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place