Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-02 @ 12:53 AM
Study NCT ID:
NCT06582251
Status:
RECRUITING
Last Update Posted:
2024-12-02
First Post:
2024-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of High-Intensity Functional Training in Tactical Populations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-29', 'studyFirstSubmitDate': '2024-08-27', 'studyFirstSubmitQcDate': '2024-08-29', 'lastUpdatePostDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in body composition body fat percentage.', 'timeFrame': 'Baseline and Week 10', 'description': 'Body fat percentage via air-displacement'}, {'measure': 'Changes in body composition fat-free mass.', 'timeFrame': 'Baseline and Week 10', 'description': 'Fat-free mass via air-displacement plethysmography.'}, {'measure': 'Changes in body composition dry fat-free mass.', 'timeFrame': 'Baseline and Week 10', 'description': 'Dry fat-free mass via air-displacement plethysmography and bio-electrical impedance.'}, {'measure': 'Changes in upper body strength.', 'timeFrame': 'Baseline and week 10', 'description': 'Upper body strength assessed by 1 repetition maximum bench press.'}, {'measure': 'Changes in lower body strength.', 'timeFrame': 'Baseline and week 10', 'description': 'Lower body strength assessed by isometric mid-thigh pulls on bilateral force plates.'}, {'measure': 'Changes in maximal oxygen consumption.', 'timeFrame': 'Baseline and week 10', 'description': 'Changes in VO2max measured by maximal graded exercise test with indirect calorimetry.'}, {'measure': 'Changes in ventilatory threshold.', 'timeFrame': 'Baseline and week 10', 'description': 'Changes in ventilatory threshold measured by maximal graded exercise test with indirect calorimetry.'}, {'measure': 'Changes in velocity at VO2 max.', 'timeFrame': 'Baseline and week 10', 'description': 'Assessed by maximal graded exercise test with indirect calorimetry.'}], 'secondaryOutcomes': [{'measure': 'Internal training load between groups.', 'timeFrame': 'Every training session over the 8-week intervention period will be included in this calculation.', 'description': 'Assessed by heart rate chest strap using Edwards training impulse calculation.'}, {'measure': 'Changes in training distress', 'timeFrame': 'Baseline, once per week for the 8 training weeks.', 'description': 'Overall training distress and subscales including depressed moods, vigor, physical signs and symptoms, sleep disturbances, perceived stress, and general fatigue using the multicomponent training distress scale, scaled 0 - 110 with higher scores indicating more distress.'}, {'measure': 'Changes in anaerobic power.', 'timeFrame': 'Baseline, once per week for the 8 training weeks.', 'description': 'Measured by countermovement jump through bilateral force plates.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['high-intensity functional training', 'tactical', 'military'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of high-intensity functional training (HIFT) as compared to traditional resistance training (RT) and concurrent training consisting of RT and high-intensity interval training (HIIT) on physical performance metrics, body composition, and mental and physical readiness of tactical personnel.', 'detailedDescription': 'This study assesses the impact of 8-weeks of high-intensity functional training (HIFT) as compared to traditional resistance training (RT) and concurrent training consisting of RT and high-intensity interval training (HIIT) on various performance outcomes. The main questions the study aims to answer are:\n\n* Evaluate the distinct effects of HIFT, RT, and RT plus HIIT over eight weeks on physical performance and body composition measures in tactical men and women.\n* Determine the distress, training load, and physical readiness associated with each of the three distinct training interventions over eight weeks.\n\nParticipants will:\n\n* Take part in 10-weeks total of study-related activity.\n* Complete four total sessions of pre and post-testing sessions, which include body composition, maximal oxygen uptake testing (VO2max), upper and lower body maximal strength, and lower body power.\n* Be randomly assigned to an exercise training intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females between the ages of 18 and 35 (inclusive) and enrolled in a reserve officer training corps program.\n* Subject has provided written and dated informed consent to participate in the study.\n* Subject is in good health as determined by medical history and is cleared for exercise.\n* BMI between 17.0 and 29.9 kg/m2.\n* "Good" category or greater for their aerobic capacity according to the American College of Sports Medicine (ACSM) normative data for their age and sex as measured at their baseline visit.\n\nExclusion Criteria:\n\n* Participants with any musculoskeletal injuries that would prevent completion of these exercise programs.\n* Participants with any metabolic disorder, including known electrolyte abnormalities, uncontrolled diabetes, uncontrolled thyroid disease, adrenal disease, or hypogonadism.\n* Participants with a history of hepatorenal, musculoskeletal, autoimmune, or neurologic disease.\n* Participants who have lost or gained greater than eight pounds within three months prior to study enrollment.\n* Participants currently taking hyperlipidemic, hypoglycemic, anti-hypertensive, or anti-coagulant medications.\n* Participants who are pregnant or lactating.'}, 'identificationModule': {'nctId': 'NCT06582251', 'acronym': 'HIFT', 'briefTitle': 'The Effects of High-Intensity Functional Training in Tactical Populations', 'organization': {'class': 'OTHER', 'fullName': 'University of South Carolina'}, 'officialTitle': 'The Effects of High-Intensity Functional Training Versus Traditional Strength Training or Concurrent Training on Performance and Readiness in Tactical Populations', 'orgStudyIdInfo': {'id': 'Pro00137947'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Intensity Functional Training', 'description': 'Training will include power and strength movements, then 30 minutes of metabolic conditioning training comprised of whole-body multi-joint movements.', 'interventionNames': ['Behavioral: High-intensity functional training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional Resistance Training', 'description': 'This group will perform traditional resistance training.', 'interventionNames': ['Behavioral: Traditional resistance training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Concurrent Training', 'description': 'This group will perform traditional resistance training followed by 20 minutes of running, high intensity intervals.', 'interventionNames': ['Behavioral: Concurrent training']}], 'interventions': [{'name': 'High-intensity functional training', 'type': 'BEHAVIORAL', 'description': 'Participants assigned to this group will undergo 8 weeks of high-intensity functional training.', 'armGroupLabels': ['High Intensity Functional Training']}, {'name': 'Traditional resistance training', 'type': 'BEHAVIORAL', 'description': 'Participants assigned to this group will undergo 8 weeks of traditional strength and hypertrophy training.', 'armGroupLabels': ['Traditional Resistance Training']}, {'name': 'Concurrent training', 'type': 'BEHAVIORAL', 'description': 'Participants assigned to this group will undergo 8 weeks of traditional strength and hypertrophy training followed by high-intensity interval aerobic training.', 'armGroupLabels': ['Concurrent Training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29208', 'city': 'Columbia', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shawn M. Arent, PhD', 'role': 'CONTACT', 'email': 'sarent@mailbox.sc.edu', 'phone': '803-576-8394'}, {'name': 'Sten O Stray-Gundersen, PhD', 'role': 'CONTACT', 'email': 'sten@mailbox.sc.edu'}], 'facility': 'University of South Carolina Sport Science Lab', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}], 'centralContacts': [{'name': 'Shawn M Arent, PhD', 'role': 'CONTACT', 'email': 'sarent@mailbox.sc.edu', 'phone': '8035768394'}, {'name': 'Gianna F Mastrofini, MS', 'role': 'CONTACT', 'email': 'giannafm@email.sc.edu', 'phone': '7034246509'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Carolina', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Strength and Conditioning Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chair of Exercise Science Department', 'investigatorFullName': 'Shawn M. Arent', 'investigatorAffiliation': 'University of South Carolina'}}}}