Brain-Physical Optimization Conditioning

Neurocognitive Optimization and Enhancement for Brain Health and Performance

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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Failure Test
Time Frame: 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).

7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic Marksmanship
Time Frame: 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.

Pre-to-post ruck time (~30-90 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 20, 2020

Primary Completion (ANTICIPATED)

October 20, 2023

Study Completion (ANTICIPATED)

October 20, 2025

Study Registration Dates

First Submitted

November 12, 2020

First Submitted That Met QC Criteria

April 27, 2021

First Posted (ACTUAL)

April 28, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 25, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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