Brain-Physical Optimization Conditioning

Physical Performance Clinical Trial

Official title:

Neurocognitive Optimization and Enhancement for Brain Health and Performance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04863469
• Other study ID #: 2751
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: October 20, 2025

Study information

• Verified date: March 2022
• Source: Walter Reed Army Institute of Research (WRAIR)
• Contact: Brad Fawver, PhD
• Phone: 253-968-4878
• Email: bradley.j.fawver.civ[@]mail.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Brain-Physical Optimization Conditioning (B-POC) aims to enhance physical performance by expanding the traditional focus of endurance training from purely physical training to the domain of cognitive endurance (Staiano et al., 2015; Dallaway et al., 2017). The current study seeks to isolate neurocognitive mechanisms of performance, particularly under high stress (e.g., physical or cognitive load) conditions, and to develop corresponding cognitive optimization tools.

Description:

Brain-Physical Optimization Conditioning (B-POC) aims to enhance physical performance by expanding the traditional focus of endurance training from purely physical training to the domain of cognitive endurance (Staiano et al., 2015; Dallaway et al., 2017). B-POC uses an acute mentally fatiguing task during routine exercise with the aim of optimizing the effects of physical endurance (e.g., aerobic exercise). B-POC differs from other types of cognitive training by increasing the cognitive demands of a specific concurrent task rather than teaching a cognitive strategy and relying on task transfer effects. Similar to strengthening a muscle, cognitive trainings may be one means of increasing Soldier's cognitive capacity and improving performance (Walton et al., 2018).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: October 20, 2025
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Healthy active duty Soldiers
• 18-40 years old
• Available for study duration

Exclusion Criteria:

• Failure of an Army Physical Fitness/Combat Test (APFT/ACFT) test
• On a physical profile that prevents them from 1) engaging in intense aerobic exercise, 2) running on a treadmill, 3) riding the stationary bike, and 4) performing a cognitive task on a computer screen.
• Medically non-deployable
• Impaired cognitive function due to medication, injury or illness,
• Have been advised by a medical professional not to engage in aerobic exercise
• Are a pregnant female

Related Conditions & MeSH terms

• Physical Performance

Intervention

Behavioral:
• B-POC high load intervention
aerobic exercise [heartrate range (HRR) 70-75% of max HR, on treadmill] and a computerized high-load task for 45 minutes, 3 times per week, for 6 weeks
• B-POC low load intervention
aerobic exercise [heartrate range (HRR) 70-75% of max HR, on treadmill] and a computerized low-load task for 45 minutes, 3 times per week, for 6 weeks

Locations

Country	Name	City	State
United States	Medical Research Directorate - West	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Walter Reed Army Institute of Research (WRAIR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Failure Test	The Time to Failure Test (TFT) requires participants to run on a treadmill with increases in either grade (0.5% increase) and speed (~0.3-0.5 mph) every two minutes in an alternating format for the first 16 minutes, after which settings remain constant until self termination of the exercise. The TFT settings (work rate) are calculated from an individual's last 2 mile run time. Physiological load (heart rate, oxygen consumption) and perceived exertion (RPE) are measured throughout the TFT.; The primary outcome is change in time to failure (minutes, seconds) on the endurance test from baseline to post0test (~7 weeks).	7 weeks
Secondary	Dynamic Marksmanship	The Dynamic Marksmanship Test requires participants to complete four increasingly difficult phases of target identification (friend vs. foe) and elimination using a rifle marksmanship simulator (EST). The test is completed both before and after a 3-mile ruck march, which is completed with +30% bodyweight. Physiological output (HR), and subjective ratings of workload (NASA-TLX) are assessed throughout each marksmanship test.; The primary outcome is change in accuracy (%) from pre-ruck performance to post-ruck performance.	Pre-to-post ruck time (~30-90 minutes)