Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2025-12-29 @ 8:52 PM
Study NCT ID:
NCT04863469
Status:
UNKNOWN
Last Update Posted:
2022-03-31
First Post:
2020-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brain-Physical Optimization Conditioning
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 66}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2025-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-25', 'studyFirstSubmitDate': '2020-11-12', 'studyFirstSubmitQcDate': '2021-04-27', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Failure Test', 'timeFrame': '7 weeks', 'description': "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.\n\nThe primary outcome is change in time to failure (minutes, seconds) on the endurance test from baseline to post0test (\\~7 weeks)."}], 'secondaryOutcomes': [{'measure': 'Dynamic Marksmanship', 'timeFrame': 'Pre-to-post ruck time (~30-90 minutes)', 'description': '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.\n\nThe primary outcome is change in accuracy (%) from pre-ruck performance to post-ruck performance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cognitive fatigue', 'demand', 'endurance performance', 'perceived exertion', 'effort'], 'conditions': ['Physical Performance']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy active duty Soldiers\n* 18-40 years old\n* Available for study duration\n\nExclusion Criteria:\n\n* Failure of an Army Physical Fitness/Combat Test (APFT/ACFT) test\n* 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.\n* Medically non-deployable\n* Impaired cognitive function due to medication, injury or illness,\n* Have been advised by a medical professional not to engage in aerobic exercise\n* Are a pregnant female'}, 'identificationModule': {'nctId': 'NCT04863469', 'briefTitle': 'Brain-Physical Optimization Conditioning', 'organization': {'class': 'FED', 'fullName': 'Walter Reed Army Institute of Research (WRAIR)'}, 'officialTitle': 'Neurocognitive Optimization and Enhancement for Brain Health and Performance', 'orgStudyIdInfo': {'id': '2751'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B-POC high load Intervention', 'description': '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', 'interventionNames': ['Behavioral: B-POC high load intervention']}, {'type': 'SHAM_COMPARATOR', 'label': 'B-POC low load intervention', 'description': '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', 'interventionNames': ['Behavioral: B-POC low load intervention']}], 'interventions': [{'name': 'B-POC high load intervention', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['B-POC high load Intervention']}, {'name': 'B-POC low load intervention', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['B-POC low load intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98433', 'city': 'Tacoma', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michael M Dretsch', 'role': 'CONTACT', 'email': 'michael.n.dretsch.mil@mail.mil'}], 'facility': 'Medical Research Directorate - West', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'centralContacts': [{'name': 'Brad Fawver, PhD', 'role': 'CONTACT', 'email': 'bradley.j.fawver.civ@mail.mil', 'phone': '253-968-4878'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Walter Reed Army Institute of Research (WRAIR)', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}