Elevated Blood PressureNCT06413251
Clinical Effectiveness of Boxing Training in Individuals With Elevated Blood Pressure or Stage 1 Hypertension
A study testing Boxing Training in people with Elevated Blood Pressure and Hypertension, run by University of Texas, El Paso at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elevated Blood Pressure, Hypertension
- What is being tested?
- Boxing Training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2020to 15 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- non-controlled cardiac, pulmonary, or metabolic diseases.
- smoking, consumption of nutritional supplements containing antioxidants.
- any physical impairment to exercise.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas at El Paso
El Paso, Texas, 79968
About this study
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
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.
Read more
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
- Elevated Blood Pressure, Hypertension
- Being tested
- Boxing Training, Control flexibility
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Boxing TrainingOther
Also called Exercise
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 flexibilityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Boxing | Experimental | The boxing training intervention will consist of three exercise sessions per week on nonconsecutive days for six weeks Receives: Other: Boxing Training |
| Control | Placebo comparator | The control group will perform three days per week 10 minutes a flexibility intervention. Receives: Other: Control flexibility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline brachial blood pressure after week six
Resting systolic and diastolic blood pressure (mmHg)
Measured: pre-intervention and immediately after the intervention
Secondary outcomes (18)
Central Blood Pressure
Pulse wave analysis (mmHg)
Measured: pre-intervention and immediately after the intervention
Vascular function
Flow mediated dilation (%)
Measured: pre-intervention and immediately after the intervention
Plethysmography
Forearm and Calf Blood Flow (ml/min/100 ml tissue)
Measured: pre-intervention and immediately after the intervention
Maximum Oxygen Uptake
Cardiopulmonary Test (ml/kg/min)
Measured: pre-intervention and immediately after the intervention
Nitric Oxide Bioavailability
Blood Biomarker NOx (μmol/L)
Measured: pre-intervention and immediately after the intervention
Body Fat Percentage
Dual energy x-ray absorptiometry Scan to assess Body Fat %
Measured: pre-intervention and immediately after the intervention
Lean Mass
Dual energy x-ray absorptiometry Scan to assess lean mass (kg)
Measured: pre-intervention and immediately after the intervention
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).
Measured: pre-intervention and immediately after the intervention
Arterial Stiffness
Pulse wave velocity from carotid to femoral artery (m/s)
Measured: pre-intervention and immediately after the intervention
C Reactive Protein (CRP) to assess inflammation
Blood Biomarker CRP (mg/L)
Measured: pre-intervention and immediately after the intervention
Interleukin-6 (IL-6) to assess inflammation
Blood Biomarker IL-6 (pg/ml)
Measured: pre-intervention and immediately after the intervention
Tumor necrosis factor alfa (TNFα) to assess inflammation
Blood Biomarker TNFα (pg/ml)
Measured: pre-intervention and immediately after the intervention
8-isoprostane to assess inflammation
Blood Biomarker 8-isoprostane (pg/ml)
Measured: pre-intervention and immediately after the intervention
Superoxide dismutase (SOD) to assess oxidative stress
Blood Biomarker SOD (mU/ml)
Measured: pre-intervention and immediately after the intervention
Total Antioxidant Capacity (TAC) to assess oxidative stress
Blood Biomarker TAC (mM/ml)
Measured: pre-intervention and immediately after the intervention
Lipid Profile
Blood Biomarkers HDL-C, LDL-C, and total cholesterol (mg/dl)
Measured: pre-intervention and immediately after the intervention
Weight
Weight in kilograms
Measured: pre-intervention and immediately after the intervention
Height
Height in meters
Measured: pre-intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start15 Jan 2020
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elevated Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas, El Paso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413251
- Sponsor's protocol ID
- 1364179-3
- Status last verified
- May 2024
- First submitted
- 22 Nov 2023
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only the PI will analyze the collected data.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06413251
- Acronym / sponsor ID
- 1364179-3
- Conditions
- Elevated Blood Pressure, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Texas, El PasoUniversity, hospital or other
- Study start
- 15 Jan 2020 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Boxing | Experimental | Other: Boxing TrainingThe boxing training intervention will consist of three exercise sessions per week on nonconsecutive days for six weeks |
| Control | Placebo comparator | Other: Control flexibilityThe control group will perform three days per week 10 minutes a flexibility intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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.
Key exclusion criteria (3 listed)
- non-controlled cardiac, pulmonary, or metabolic diseases.
- smoking, consumption of nutritional supplements containing antioxidants.
- any physical impairment to exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Boxing TrainingAlso: ExerciseThe 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 | Boxing |
| Control flexibilityThe 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. | Other | Control |
Primary outcome
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)
18 secondary outcomes
Central Blood Pressure
Time frame: pre-intervention and immediately after the intervention
Vascular function
Time frame: pre-intervention and immediately after the intervention
Plethysmography
Time frame: pre-intervention and immediately after the intervention
Maximum Oxygen Uptake
Time frame: pre-intervention and immediately after the intervention
Nitric Oxide Bioavailability
Time frame: pre-intervention and immediately after the intervention
Body Fat Percentage
Time frame: pre-intervention and immediately after the intervention
Lean Mass
Time frame: pre-intervention and immediately after the intervention
Quality of Life measured by the short-form 36 (SF-36)
Time frame: pre-intervention and immediately after the intervention
Arterial Stiffness
Time frame: pre-intervention and immediately after the intervention
C Reactive Protein (CRP) to assess inflammation
Time frame: pre-intervention and immediately after the intervention
Interleukin-6 (IL-6) to assess inflammation
Time frame: pre-intervention and immediately after the intervention
Tumor necrosis factor alfa (TNFα) to assess inflammation
Time frame: pre-intervention and immediately after the intervention
8-isoprostane to assess inflammation
Time frame: pre-intervention and immediately after the intervention
Superoxide dismutase (SOD) to assess oxidative stress
Time frame: pre-intervention and immediately after the intervention
Total Antioxidant Capacity (TAC) to assess oxidative stress
Time frame: pre-intervention and immediately after the intervention
Lipid Profile
Time frame: pre-intervention and immediately after the intervention
Weight
Time frame: pre-intervention and immediately after the intervention
Height
Time frame: pre-intervention and immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No. Only the PI will analyze the collected data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Boxing Training in people with Elevated Blood Pressure and Hypertension, run by University of Texas, El Paso at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline brachial blood pressure after week six (time frame: pre-intervention and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.