## Protocol Section
### Identification Module
**NCT ID:** NCT06413251

**Brief Title:** Clinical Effectiveness of Boxing Training in Individuals With Elevated Blood Pressure or Stage 1 Hypertension

**Official Title:** 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

#### Organization Study ID Info
**ID:** 1364179-3
#### Organization
**Class:** OTHER
**Full Name:** University of Texas, El Paso
### Status Module
#### Completion Date
**Date:** 2020-03-15

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2020-03-15

**Type:** ACTUAL

#### Start Date
**Date:** 2020-01-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2023-11-22
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Texas, El Paso

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Elevated Blood Pressure

- Hypertension

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** 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.

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 24

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The boxing training intervention will consist of three exercise sessions per week on nonconsecutive days for six weeks

**Intervention Names:**

- Other: Boxing Training

**Label:** Boxing

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The control group will perform three days per week 10 minutes a flexibility intervention.

**Intervention Names:**

- Other: Control flexibility

**Label:** Control

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Boxing

**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.

**Name:** Boxing Training

**Other Names:**

- Exercise

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Control

**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.

**Name:** Control flexibility

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Resting systolic and diastolic blood pressure (mmHg)

**Measure:** Change from baseline brachial blood pressure after week six

**Time Frame:** pre-intervention and immediately after the intervention

#### Secondary Outcomes

**Description:** Pulse wave analysis (mmHg)

**Measure:** Central Blood Pressure

**Time Frame:** pre-intervention and immediately after the intervention

**Description:** Flow mediated dilation (%)

**Measure:** Vascular function

**Time Frame:** pre-intervention and immediately after the intervention

**Description:** Forearm and Calf Blood Flow (ml/min/100 ml tissue)

**Measure:** Plethysmography

**Time Frame:** pre-intervention and immediately after the intervention

**Description:** Cardiopulmonary Test (ml/kg/min)

**Measure:** Maximum Oxygen Uptake

**Time Frame:** pre-intervention and immediately after the intervention

**Description:** Blood Biomarker NOx (μmol/L)

**Measure:** Nitric Oxide Bioavailability

**Time Frame:** pre-intervention and immediately after the intervention

**Description:** Dual energy x-ray absorptiometry Scan to assess Body Fat %

**Measure:** Body Fat Percentage

**Time Frame:** pre-intervention and immediately after the intervention

**Description:** Dual energy x-ray absorptiometry Scan to assess lean mass (kg)

**Measure:** Lean Mass

**Time Frame:** 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:** Quality of Life measured by the short-form 36 (SF-36)

**Time Frame:** pre-intervention and immediately after the intervention

**Description:** Pulse wave velocity from carotid to femoral artery (m/s)

**Measure:** Arterial Stiffness

**Time Frame:** pre-intervention and immediately after the intervention

**Description:** Blood Biomarker CRP (mg/L)

**Measure:** C Reactive Protein (CRP) to assess inflammation

**Time Frame:** pre-intervention and immediately after the intervention

**Description:** Blood Biomarker IL-6 (pg/ml)

**Measure:** Interleukin-6 (IL-6) to assess inflammation

**Time Frame:** pre-intervention and immediately after the intervention

**Description:** Blood Biomarker TNFα (pg/ml)

**Measure:** Tumor necrosis factor alfa (TNFα) to assess inflammation

**Time Frame:** pre-intervention and immediately after the intervention

**Description:** Blood Biomarker 8-isoprostane (pg/ml)

**Measure:** 8-isoprostane to assess inflammation

**Time Frame:** pre-intervention and immediately after the intervention

**Description:** Blood Biomarker SOD (mU/ml)

**Measure:** Superoxide dismutase (SOD) to assess oxidative stress

**Time Frame:** pre-intervention and immediately after the intervention

**Description:** Blood Biomarker TAC (mM/ml)

**Measure:** Total Antioxidant Capacity (TAC) to assess oxidative stress

**Time Frame:** pre-intervention and immediately after the intervention

**Description:** Blood Biomarkers HDL-C, LDL-C, and total cholesterol (mg/dl)

**Measure:** Lipid Profile

**Time Frame:** pre-intervention and immediately after the intervention

**Description:** Weight in kilograms

**Measure:** Weight

**Time Frame:** pre-intervention and immediately after the intervention

**Description:** Height in meters

**Measure:** Height

**Time Frame:** pre-intervention and immediately after the intervention

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** El Paso

**Country:** United States

**Facility:** The University of Texas at El Paso

**State:** Texas

**Zip:** 79968

### IPD Sharing Statement Module

**Description:** Only the PI will analyze the collected data.

**IPD Sharing:** NO

## Document Section

### Large Document Module

#### Large Docs

- Date: 2023-12-11

- Filename: Prot_SAP_ICF_000.pdf

- Has ICF: True

- Has Protocol: True

- Has SAP: True

- Label: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

- Size: 254468

- Type Abbrev: Prot_SAP_ICF

- Upload Date: 2023-12-12T10:45

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

### Condition Browse Module - Browse Leaves

- ID: M10024

- Name: Hypertension

- Relevance: HIGH

- As Found: Elevated Blood Pressure

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T6034

- Name: Quality of Life

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006973

- Term: Hypertension

### Misc Info Module

- Version Holder: 2024-05-31
