Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-25 @ 5:14 PM
Study NCT ID:
NCT05309603
Status:
COMPLETED
Last Update Posted:
2023-08-16
First Post:
2022-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alterations in Gait, Strength, and Power After Ruck Marching
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D005221', 'term': 'Fatigue'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016138', 'term': 'Walking'}], 'ancestors': [{'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-15', 'studyFirstSubmitDate': '2022-03-24', 'studyFirstSubmitQcDate': '2022-04-01', 'lastUpdatePostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Oxygen Consumption', 'timeFrame': 'Upon completion of 3 miles of walking, an average of 45 minutes', 'description': 'Oxygen consumption will be measured using indirect calorimetry'}, {'measure': 'Increased muscular jerk', 'timeFrame': 'Upon completion of 3 miles of walking, an average of 45 minutes', 'description': 'Jerk will be measured using accelerometers placed at the torso and ankle'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Exercise', 'Fatigue']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine change in injury risk and performance variables in males and females after walking unloaded and carrying a load with two different distributions (high-pack placement and mid-pack placement) to identify differences in injury risk'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, physically active individuals\n* 18-39 years old\n\nExclusion Criteria:\n\n* History of musculoskeletal injury within the last six months or still under a physicians care for an injury occurring more than six month prior\n* History of spinal disc injury\n* History of cardiovascular, metabolic, respiratory, neural, or renal disease\n* No previous history or education of completing resistance exercise\n* Hypertensive or tachycardic during the screening visit (SBP \\> 139 mmHg, DBP \\> 89 mmHg, heart rate \\> 100 bpm)\n* Taking medication or supplements with a known side effect of affecting physiologic responses to exercise (e.g., beta blockers, omega-3 fatty acids, statins, aspirin)\n* Any form of tobacco or nicotine use\n* A positive pregnancy test at any point in the study\n* Study physician discretion based on any other medical condition or medication\n* Gastrointestinal disease or previous surgery prohibiting internal body temperature pill use. Subjects who have any contraindication to internal body temperature pill ingestion will be given the option to insert the pill rectally (as a suppository) or use a rectal probe.'}, 'identificationModule': {'nctId': 'NCT05309603', 'acronym': 'SPARTAN', 'briefTitle': 'Alterations in Gait, Strength, and Power After Ruck Marching', 'organization': {'class': 'OTHER', 'fullName': 'State University of New York at Buffalo'}, 'officialTitle': 'Alterations in Gait, Strength, and Power After Ruck Marching', 'orgStudyIdInfo': {'id': 'STUDY00006175'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Unloaded Walking', 'description': 'Walking on a treadmill without wearing a pack', 'interventionNames': ['Other: Walking']}, {'type': 'EXPERIMENTAL', 'label': 'Loaded Walking High', 'description': 'Walking on a treadmill while wearing a 30% body mass load with the weight placed at the high-back', 'interventionNames': ['Other: Loaded Walking High']}, {'type': 'EXPERIMENTAL', 'label': 'Loaded Walking Mid', 'description': 'Walking on a treadmill while wearing a 30% body mass load with the weight placed at the mid-back', 'interventionNames': ['Other: Loaded Walking Mid']}], 'interventions': [{'name': 'Loaded Walking High', 'type': 'OTHER', 'description': 'Walking three miles on a treadmill at a self-selected speed while wearing a backpack with weight carried high on the back', 'armGroupLabels': ['Loaded Walking High']}, {'name': 'Loaded Walking Mid', 'type': 'OTHER', 'description': 'Walking three miles on a treadmill at a self-selected speed while wearing a backpack with weight carried on the mid-back', 'armGroupLabels': ['Loaded Walking Mid']}, {'name': 'Walking', 'type': 'OTHER', 'description': 'Walking three miles on a treadmill at a self-selected speed', 'armGroupLabels': ['Unloaded Walking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14214', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University at Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Riana Pryor, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University at Buffalo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We do not plan to share IPD with other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'State University of New York at Buffalo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Riana Pryor', 'investigatorAffiliation': 'State University of New York at Buffalo'}}}}