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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06413251
Other study ID # 1364179-3
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2020
Est. completion date March 15, 2020

Study information

Verified date May 2024
Source University of Texas, El Paso
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this clinical trial is to determine whether boxing training reduces cardiovascular risk in elevated blood pressure or hypertension stage 1 individuals. The 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. Participants 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. Researchers will compare clinical and cardiovascular outcomes between the control and the intervention group.


Recruitment information / eligibility

Status Completed
Enrollment 24
Est. completion date March 15, 2020
Est. primary completion date March 15, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - =18 years old. - Systolic blood pressure between 120-139 mmHg and/or diastolic blood pressure between 80-89 mmHg obtained from 2 different days. - an estimated 10-year risk of CVD =10%, calculated by the ACC/AHA Pooled Cohort Equations. - no current participation in 3 or more days per week of endurance or resistance exercise training. Exclusion Criteria: - non-controlled cardiac, pulmonary, or metabolic diseases. - smoking, consumption of nutritional supplements containing antioxidants. - any physical impairment to exercise.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Boxing Training
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.
Control flexibility
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.

Locations

Country Name City State
United States The University of Texas at El Paso El Paso Texas

Sponsors (1)

Lead Sponsor Collaborator
University of Texas, El Paso

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline brachial blood pressure after week six Resting systolic and diastolic blood pressure (mmHg) pre-intervention and immediately after the intervention
Secondary Central Blood Pressure Pulse wave analysis (mmHg) pre-intervention and immediately after the intervention
Secondary Vascular function Flow mediated dilation (%) pre-intervention and immediately after the intervention
Secondary Plethysmography Forearm and Calf Blood Flow (ml/min/100 ml tissue) pre-intervention and immediately after the intervention
Secondary Maximum Oxygen Uptake Cardiopulmonary Test (ml/kg/min) pre-intervention and immediately after the intervention
Secondary Nitric Oxide Bioavailability Blood Biomarker NOx (µmol/L) pre-intervention and immediately after the intervention
Secondary Body Fat Percentage Dual energy x-ray absorptiometry Scan to assess Body Fat % pre-intervention and immediately after the intervention
Secondary Lean Mass Dual energy x-ray absorptiometry Scan to assess lean mass (kg) pre-intervention and immediately after the intervention
Secondary Quality of Life measured by the short-form 36 (SF-36) 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). pre-intervention and immediately after the intervention
Secondary Arterial Stiffness Pulse wave velocity from carotid to femoral artery (m/s) pre-intervention and immediately after the intervention
Secondary C Reactive Protein (CRP) to assess inflammation Blood Biomarker CRP (mg/L) pre-intervention and immediately after the intervention
Secondary Interleukin-6 (IL-6) to assess inflammation Blood Biomarker IL-6 (pg/ml) pre-intervention and immediately after the intervention
Secondary Tumor necrosis factor alfa (TNFa) to assess inflammation Blood Biomarker TNFa (pg/ml) pre-intervention and immediately after the intervention
Secondary 8-isoprostane to assess inflammation Blood Biomarker 8-isoprostane (pg/ml) pre-intervention and immediately after the intervention
Secondary Superoxide dismutase (SOD) to assess oxidative stress Blood Biomarker SOD (mU/ml) pre-intervention and immediately after the intervention
Secondary Total Antioxidant Capacity (TAC) to assess oxidative stress Blood Biomarker TAC (mM/ml) pre-intervention and immediately after the intervention
Secondary Lipid Profile Blood Biomarkers HDL-C, LDL-C, and total cholesterol (mg/dl) pre-intervention and immediately after the intervention
Secondary Weight Weight in kilograms pre-intervention and immediately after the intervention
Secondary Height Height in meters pre-intervention and immediately after the intervention
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