- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04863469
Brain-Physical Optimization Conditioning
Neurocognitive Optimization and Enhancement for Brain Health and Performance
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brad Fawver, PhD
- Phone Number: 253-968-4878
- Email: bradley.j.fawver.civ@mail.mil
Study Locations
-
-
Washington
-
Tacoma, Washington, United States, 98433
- Recruiting
- Medical Research Directorate - West
-
Contact:
- Michael M Dretsch
- Email: michael.n.dretsch.mil@mail.mil
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2751
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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