CClinicalTrials.gg
RecruitingNCT04863469Updated Mar 31, 2022

Brain-Physical Optimization Conditioning

An interventional study of B-POC high load intervention and B-POC low load intervention in Physical Performance, sponsored by Walter Reed Army Institute of Research (WRAIR). Recruiting at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-31.

Sponsored by Walter Reed Army Institute of Research (WRAIR) · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Physical Performance

Keywords

  • cognitive fatigue
  • demand
  • endurance performance
  • perceived exertion
  • effort
03

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
66 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BehavioralB-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

  • BehavioralB-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

05

What researchers measure

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).

    Time frame: 7 weeks

Secondary outcomes

  1. 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.

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

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT04863469
Lead sponsor
Walter Reed Army Institute of Research (WRAIR)
Responsible party
Sponsor
First posted
Apr 28, 2021
Start date
Oct 20, 2020
Primary completion
Oct 20, 2023 (estimated)
Completion
Oct 20, 2025 (estimated)
Last update
Mar 31, 2022

Study contacts

Brad Fawver, PhD
Contact
bradley.j.fawver.civ@mail.mil
253-968-4878

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion