Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2025-12-26 @ 3:52 AM
Study NCT ID:
NCT06935318
Status:
COMPLETED
Last Update Posted:
2025-04-20
First Post:
2025-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of High Functional Resistance Training Program on Arterial Stiffness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-16', 'studyFirstSubmitDate': '2025-04-10', 'studyFirstSubmitQcDate': '2025-04-16', 'lastUpdatePostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulse wave velocity', 'timeFrame': 'From enrollment to the end of treatment at 11 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pulse wave velocity', 'beta-stiffness index', 'central arterial blood pressure', 'CrossFit training'], 'conditions': ['Training Study']}, 'referencesModule': {'references': [{'pmid': '32874096', 'type': 'BACKGROUND', 'citation': 'Garcia-Mateo P, Garcia-de-Alcaraz A, Rodriguez-Perez MA, Alcaraz-Ibanez M. Effects of Resistance Training on Arterial Stiffness in Healthy People: A Systematic Review. J Sports Sci Med. 2020 Aug 13;19(3):444-451. eCollection 2020 Sep.'}]}, 'descriptionModule': {'briefSummary': 'Study examined the effects of CrossFit training on blood vessels. The results indicate long term CrossFit training does not harm blood vessel function.', 'detailedDescription': "Arterial stiffness is a systemic loss of elastic properties that significantly augment cardiovascular disease risk in adults. Chronic aerobic and anaerobic exercise activity has consistently been shown to attenuate or not affect markers of arterial stiffness in adults with chronic disease and otherwise healthy adults. Chronic high functional resistance training's effect on vascular compliance is less understood. The study aimed to determine the impact of a chronic high functional resistance training program on pulse wave velocity and beta-stiffness index. Accordingly, participants (18-40 years old) were placed in a non-randomized fashion into high functional resistance training (HIB) group (n = 9; \\>6 months of CrossFit experience; 4 female) or control (CON) group (n = 8; \\< 6 months of exercise experience; 6 female). Participants in the HIB group trained at the same local facility 4 -5 days a week, utilizing the same training program. CON group refrained from exercise during the study period. Body composition, 1,000-meter rowing test, deadlift 1 repetition maximum (1 RM), hemodynamic assessments, and vascular compliance were assessed at baseline and follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* body weight stability with no more than ± 2.5 kg fluctuations in last six month\n\nExclusion Criteria:\n\n* hypertension\n* heart disease\n* cancer\n* diabetes\n* renal disease\n* hepatic disorders\n* history of tobacco use.'}, 'identificationModule': {'nctId': 'NCT06935318', 'briefTitle': 'Effects of High Functional Resistance Training Program on Arterial Stiffness', 'organization': {'class': 'OTHER', 'fullName': 'Salisbury University'}, 'officialTitle': 'Effects of an 11-Week High Functional Resistance Training Program on Indices of Arterial Stiffness', 'orgStudyIdInfo': {'id': '#1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise Group', 'interventionNames': ['Other: Exercise']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Exercise', 'type': 'OTHER', 'description': 'The exercise group performed an 11-week high-functional resistance program in a group training format. They trained 3-4 days a week following nationally assigned workouts', 'armGroupLabels': ['Exercise Group']}, {'name': 'Control', 'type': 'OTHER', 'description': 'Did not participate in exercise related activities for the duration of the study period.', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21801', 'city': 'Salisbury', 'state': 'Maryland', 'country': 'United States', 'facility': 'Salisbury University', 'geoPoint': {'lat': 38.36067, 'lon': -75.59937}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'ipdSharing': 'YES', 'description': 'Data will be shared upon request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Salisbury University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Timothy Werner', 'investigatorAffiliation': 'Salisbury University'}}}}