NCT04863469

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2020

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2025

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

3 years

First QC Date

November 12, 2020

Last Update Submit

March 25, 2022

Conditions

Keywords

cognitive fatiguedemandendurance performanceperceived exertioneffort

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Dynamic Marksmanship

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

Study Arms (2)

B-POC high load Intervention

EXPERIMENTAL

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

B-POC low load intervention

SHAM COMPARATOR

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

Interventions

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 high 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

B-POC low load intervention

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy active duty Soldiers
  • years old
  • Available for study duration

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Directorate - West

Tacoma, Washington, 98433, United States

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2020

First Posted

April 28, 2021

Study Start

October 20, 2020

Primary Completion

October 20, 2023

Study Completion

October 20, 2025

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations