NCT06413251

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

November 22, 2023

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

2 months

First QC Date

November 22, 2023

Last Update Submit

May 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline brachial blood pressure after week six

    Resting systolic and diastolic blood pressure (mmHg)

    pre-intervention and immediately after the intervention

Secondary Outcomes (18)

  • Central Blood Pressure

    pre-intervention and immediately after the intervention

  • Vascular function

    pre-intervention and immediately after the intervention

  • Plethysmography

    pre-intervention and immediately after the intervention

  • Maximum Oxygen Uptake

    pre-intervention and immediately after the intervention

  • Nitric Oxide Bioavailability

    pre-intervention and immediately after the intervention

  • +13 more secondary outcomes

Study Arms (2)

Boxing

EXPERIMENTAL

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

Other: Boxing Training

Control

PLACEBO COMPARATOR

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

Other: Control flexibility

Interventions

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.

Also known as: Exercise
Boxing

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.

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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.

You may not qualify if:

  • non-controlled cardiac, pulmonary, or metabolic diseases.
  • smoking, consumption of nutritional supplements containing antioxidants.
  • any physical impairment to exercise.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas at El Paso

El Paso, Texas, 79968, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2023

First Posted

May 14, 2024

Study Start

January 15, 2020

Primary Completion

March 15, 2020

Study Completion

March 15, 2020

Last Updated

May 14, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Only the PI will analyze the collected data.

Locations