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

Healthy Adults Clinical Trial

— BBT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03032796
• Other study ID #: 1R21MH110743-01
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: March 2020

Study information

• Verified date: June 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy Adults

Intervention

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.
• 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 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
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.

Locations

Country	Name	City	State
United States	UCSF Neuroscape	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Blood Pressure measures	Assessing a change in systolic & diastolic pressure following the intervention	Before and following the intervention (1 week after intervention use has ended)
Other	VO2max	Assessing a change in VO2max following the intervention	Before and following the intervention (1 week after intervention use has ended)
Other	MRI Structural measurement	Assessing a change in structural profiles following the intervention	Before and following the intervention (1 week after intervention use has ended)
Other	MRI functional activity	Assessing a change in functional activation profiles following the intervention	Before and following the intervention (1 week after intervention use has ended)
Other	EEG functional measures (event-related potentials)	Assessing a change in event-related potentials following the intervention	Before and following the intervention (1 week after intervention use has ended)
Other	EEG functional measure (event-related spectral perturbation)	Assessing a change in event-related spectral perturbation following the intervention	Before and following the intervention (1 week after intervention use has ended)
Other	EEG functional measure (long-range coherence)	Assessing a change in coherence following the intervention	Before and following the intervention (1 week after intervention use has ended)
Primary	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 (1 week after intervention use has ended)
Secondary	Delayed Recognition Working Memory Task	A change from baseline regarding measurement of working memory abilities in the presence of interference	At baseline and following the intervention (1 week after intervention use has ended)