Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT06413251
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2023-11-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Effectiveness of Boxing Training in Individuals With Elevated Blood Pressure or Stage 1 Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-11', 'size': 254468, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2023-12-12T10:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be recruited from the University of Texas at El Paso and its surroundings. They will be identified by a preliminary blood pressure screening and a health questionnaire. The inclusion criteria will consist on: (1) ≥18 years old, (2) SBP between 120-139 mmHg or DBP between 80-89 mmHg obtained from 2 different days, (3) an estimated 10-year risk of CVD ≤10%, calculated by the ACC/AHA Pooled Cohort Equations, and (4) no current participation in 3 or more days per week of endurance or resistance exercise training. Exclusion criteria will include non-controlled cardiac, pulmonary, or metabolic diseases, smoking, consumption of nutritional supplements containing antioxidants, and any physical impairment to exercise.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-09', 'studyFirstSubmitDate': '2023-11-22', 'studyFirstSubmitQcDate': '2024-05-09', 'lastUpdatePostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline brachial blood pressure after week six', 'timeFrame': 'pre-intervention and immediately after the intervention', 'description': 'Resting systolic and diastolic blood pressure (mmHg)'}], 'secondaryOutcomes': [{'measure': 'Central Blood Pressure', 'timeFrame': 'pre-intervention and immediately after the intervention', 'description': 'Pulse wave analysis (mmHg)'}, {'measure': 'Vascular function', 'timeFrame': 'pre-intervention and immediately after the intervention', 'description': 'Flow mediated dilation (%)'}, {'measure': 'Plethysmography', 'timeFrame': 'pre-intervention and immediately after the intervention', 'description': 'Forearm and Calf Blood Flow (ml/min/100 ml tissue)'}, {'measure': 'Maximum Oxygen Uptake', 'timeFrame': 'pre-intervention and immediately after the intervention', 'description': 'Cardiopulmonary Test (ml/kg/min)'}, {'measure': 'Nitric Oxide Bioavailability', 'timeFrame': 'pre-intervention and immediately after the intervention', 'description': 'Blood Biomarker NOx (μmol/L)'}, {'measure': 'Body Fat Percentage', 'timeFrame': 'pre-intervention and immediately after the intervention', 'description': 'Dual energy x-ray absorptiometry Scan to assess Body Fat %'}, {'measure': 'Lean Mass', 'timeFrame': 'pre-intervention and immediately after the intervention', 'description': 'Dual energy x-ray absorptiometry Scan to assess lean mass (kg)'}, {'measure': 'Quality of Life measured by the short-form 36 (SF-36)', 'timeFrame': 'pre-intervention and immediately after the intervention', 'description': 'The short form 36 (SF-36) is a short survey that covers a total of 8 sub-dimensions related to physical and mental health: (1) Physical Functioning, (2) Role Limitations due to Physical Problems, (3) Social Functioning, (4) Bodily Pain, (5) General Mental Health, (6) Role Limitations due to Mental Problems, (7) Vitality, and (8) General Health Perceptions. The SF-36 includes a diverse mixture of continuous item scaling methods and is comprised of 10 items with balanced multi-item response formats (range from 1 to 5), 7 items with a dichotomous response format (1 or 2), and 19 items with non-balanced multi-item response formats (nine items range from 1 to 3 and ten items range from 1 to 6). To obtain the raw score for each sub-dimension, 10 items are reversed. Then, raw values for each sub-dimension are summed. Finally, the raw scores are transformed to a 0-to-100 scale for each sub-dimension. Higher scores indicate higher Quality of Life from 0 (worst) to 100 (best).'}, {'measure': 'Arterial Stiffness', 'timeFrame': 'pre-intervention and immediately after the intervention', 'description': 'Pulse wave velocity from carotid to femoral artery (m/s)'}, {'measure': 'C Reactive Protein (CRP) to assess inflammation', 'timeFrame': 'pre-intervention and immediately after the intervention', 'description': 'Blood Biomarker CRP (mg/L)'}, {'measure': 'Interleukin-6 (IL-6) to assess inflammation', 'timeFrame': 'pre-intervention and immediately after the intervention', 'description': 'Blood Biomarker IL-6 (pg/ml)'}, {'measure': 'Tumor necrosis factor alfa (TNFα) to assess inflammation', 'timeFrame': 'pre-intervention and immediately after the intervention', 'description': 'Blood Biomarker TNFα (pg/ml)'}, {'measure': '8-isoprostane to assess inflammation', 'timeFrame': 'pre-intervention and immediately after the intervention', 'description': 'Blood Biomarker 8-isoprostane (pg/ml)'}, {'measure': 'Superoxide dismutase (SOD) to assess oxidative stress', 'timeFrame': 'pre-intervention and immediately after the intervention', 'description': 'Blood Biomarker SOD (mU/ml)'}, {'measure': 'Total Antioxidant Capacity (TAC) to assess oxidative stress', 'timeFrame': 'pre-intervention and immediately after the intervention', 'description': 'Blood Biomarker TAC (mM/ml)'}, {'measure': 'Lipid Profile', 'timeFrame': 'pre-intervention and immediately after the intervention', 'description': 'Blood Biomarkers HDL-C, LDL-C, and total cholesterol (mg/dl)'}, {'measure': 'Weight', 'timeFrame': 'pre-intervention and immediately after the intervention', 'description': 'Weight in kilograms'}, {'measure': 'Height', 'timeFrame': 'pre-intervention and immediately after the intervention', 'description': 'Height in meters'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Elevated Blood Pressure', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to determine whether boxing training reduces cardiovascular risk in elevated blood pressure or hypertension stage 1 individuals.\n\nThe main questions it aims to answer are (1) if boxing training reduces peripheral and central blood pressure and (2) if boxing training improves cardiovascular function in elevated blood pressure or hypertension stage 1 individuals.\n\nParticipants with elevated blood pressure or hypertension stage 1 will be randomly divided into a control group or an intervention group. The latter group will be involved in boxing training, 3 days per week for 6 weeks.\n\nResearchers will compare clinical and cardiovascular outcomes between the control and the intervention group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 years old.\n* Systolic blood pressure between 120-139 mmHg and/or diastolic blood pressure between 80-89 mmHg obtained from 2 different days.\n* an estimated 10-year risk of CVD ≤10%, calculated by the ACC/AHA Pooled Cohort Equations.\n* no current participation in 3 or more days per week of endurance or resistance exercise training.\n\nExclusion Criteria:\n\n* non-controlled cardiac, pulmonary, or metabolic diseases.\n* smoking, consumption of nutritional supplements containing antioxidants.\n* any physical impairment to exercise.'}, 'identificationModule': {'nctId': 'NCT06413251', 'briefTitle': 'Clinical Effectiveness of Boxing Training in Individuals With Elevated Blood Pressure or Stage 1 Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas, El Paso'}, 'officialTitle': 'Boxing Training Effects on Cardiovascular Risk, Quality of Life, Endothelial Function, and Blood Flow Patterns in Individuals With Elevated Blood Pressure or Stage 1 Hypertension', 'orgStudyIdInfo': {'id': '1364179-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Boxing', 'description': 'The boxing training intervention will consist of three exercise sessions per week on nonconsecutive days for six weeks', 'interventionNames': ['Other: Boxing Training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'The control group will perform three days per week 10 minutes a flexibility intervention.', 'interventionNames': ['Other: Control flexibility']}], 'interventions': [{'name': 'Boxing Training', 'type': 'OTHER', 'otherNames': ['Exercise'], 'description': 'The boxing training intervention will consist of three exercise sessions per week on nonconsecutive days for six weeks. Participants will be instructed to complete 10 rounds of three minutes with a one-minute resting period interspersed. Four rounds will consist of heavy bag punching (e.g. straight, jab, hook) at 60% VO2max and three rounds at 90-95% VO2max, while the remaining 3 rounds will be focused on mitt work at 60% VO2max.', 'armGroupLabels': ['Boxing']}, {'name': 'Control flexibility', 'type': 'OTHER', 'description': 'The control group will perform three days per week 10 minutes of dynamic articular movement, five minutes of uni pedal stance, and five minutes of stretching of the upper limbs for six weeks.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79968', 'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas at El Paso', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only the PI will analyze the collected data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas, El Paso', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}