Brain-Physical Optimization Conditioning

• Sponsor: Walter Reed Army Institute of Research (WRAIR) (U.S. Fed)
• Overall Status: Recruiting
• CT.gov ID: NCT04863469
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Physical Performance	Behavioral: B-POC high load intervention; Behavioral: B-POC low load intervention	N/A

Detailed 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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Neurocognitive Optimization and Enhancement for Brain Health and Performance
• Actual Study Start Date: Oct 20, 2020
• Anticipated Primary Completion Date: Oct 20, 2023
• Anticipated Study Completion Date: Oct 20, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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
Sham Comparator: 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	Behavioral: 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

Outcome Measures

Primary Outcome Measures

1. Time to Failure Test [7 weeks]

   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).

Secondary Outcome Measures

1. Dynamic Marksmanship [Pre-to-post ruck time (~30-90 minutes)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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,

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Research Directorate - West	Tacoma	Washington	United States	98433

Sponsors and Collaborators

• Walter Reed Army Institute of Research (WRAIR)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Walter Reed Army Institute of Research (WRAIR)
• ClinicalTrials.gov Identifier: NCT04863469
• Other Study ID Numbers: 2751
• First Posted: Apr 28, 2021
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Walter Reed Army Institute of Research (WRAIR): cognitive fatigue; demand; endurance performance; perceived exertion; effort

Study Results

No Results Posted as of Mar 31, 2022