- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06413251
Clinical Effectiveness of Boxing Training in Individuals With Elevated Blood Pressure or Stage 1 Hypertension
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Texas
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El Paso, Texas, United States, 79968
- The University of Texas at El Paso
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Boxing
The boxing training intervention will consist of three exercise sessions per week on nonconsecutive days for six weeks
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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.
Other Names:
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Placebo Comparator: Control
The control group will perform three days per week 10 minutes a flexibility intervention.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline brachial blood pressure after week six
Time Frame: pre-intervention and immediately after the intervention
|
Resting systolic and diastolic blood pressure (mmHg)
|
pre-intervention and immediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Central Blood Pressure
Time Frame: pre-intervention and immediately after the intervention
|
Pulse wave analysis (mmHg)
|
pre-intervention and immediately after the intervention
|
|
Vascular function
Time Frame: pre-intervention and immediately after the intervention
|
Flow mediated dilation (%)
|
pre-intervention and immediately after the intervention
|
|
Plethysmography
Time Frame: pre-intervention and immediately after the intervention
|
Forearm and Calf Blood Flow (ml/min/100 ml tissue)
|
pre-intervention and immediately after the intervention
|
|
Maximum Oxygen Uptake
Time Frame: pre-intervention and immediately after the intervention
|
Cardiopulmonary Test (ml/kg/min)
|
pre-intervention and immediately after the intervention
|
|
Nitric Oxide Bioavailability
Time Frame: pre-intervention and immediately after the intervention
|
Blood Biomarker NOx (μmol/L)
|
pre-intervention and immediately after the intervention
|
|
Body Fat Percentage
Time Frame: pre-intervention and immediately after the intervention
|
Dual energy x-ray absorptiometry Scan to assess Body Fat %
|
pre-intervention and immediately after the intervention
|
|
Lean Mass
Time Frame: pre-intervention and immediately after the intervention
|
Dual energy x-ray absorptiometry Scan to assess lean mass (kg)
|
pre-intervention and immediately after the intervention
|
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Quality of Life measured by the short-form 36 (SF-36)
Time Frame: pre-intervention and immediately after the intervention
|
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
|
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Arterial Stiffness
Time Frame: pre-intervention and immediately after the intervention
|
Pulse wave velocity from carotid to femoral artery (m/s)
|
pre-intervention and immediately after the intervention
|
|
C Reactive Protein (CRP) to assess inflammation
Time Frame: pre-intervention and immediately after the intervention
|
Blood Biomarker CRP (mg/L)
|
pre-intervention and immediately after the intervention
|
|
Interleukin-6 (IL-6) to assess inflammation
Time Frame: pre-intervention and immediately after the intervention
|
Blood Biomarker IL-6 (pg/ml)
|
pre-intervention and immediately after the intervention
|
|
Tumor necrosis factor alfa (TNFα) to assess inflammation
Time Frame: pre-intervention and immediately after the intervention
|
Blood Biomarker TNFα (pg/ml)
|
pre-intervention and immediately after the intervention
|
|
8-isoprostane to assess inflammation
Time Frame: pre-intervention and immediately after the intervention
|
Blood Biomarker 8-isoprostane (pg/ml)
|
pre-intervention and immediately after the intervention
|
|
Superoxide dismutase (SOD) to assess oxidative stress
Time Frame: pre-intervention and immediately after the intervention
|
Blood Biomarker SOD (mU/ml)
|
pre-intervention and immediately after the intervention
|
|
Total Antioxidant Capacity (TAC) to assess oxidative stress
Time Frame: pre-intervention and immediately after the intervention
|
Blood Biomarker TAC (mM/ml)
|
pre-intervention and immediately after the intervention
|
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Lipid Profile
Time Frame: pre-intervention and immediately after the intervention
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Blood Biomarkers HDL-C, LDL-C, and total cholesterol (mg/dl)
|
pre-intervention and immediately after the intervention
|
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Weight
Time Frame: pre-intervention and immediately after the intervention
|
Weight in kilograms
|
pre-intervention and immediately after the intervention
|
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Height
Time Frame: pre-intervention and immediately after the intervention
|
Height in meters
|
pre-intervention and immediately after the intervention
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1364179-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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