The BEE-Power Study (Boosting Exercise for Excellent Pediatric Blood Pressure)

The goal of this study is to compare two types of exercises, isometric exercise (like squats and planks) and aerobic exercise (such as running), to see which one is more effective at improving blood pressure in teenagers aged 13 to 17.5 years.

The main question the study aims to answer is:

- Do the effects of one session of isometric exercise on the blood pressure of adolescents compare to the effects of one session of aerobic exercise?

Adolescents with overweight or obesity may qualify for this study. Participants will be randomly assigned to either a single session of isometric exercise or a single session of aerobic exercise.

  • Participants will attend 3 study visits in total.
  • Study visits should be completed within 4 weeks of enrollment.
  • At the initial visit, samples (example: blood) will be collected and body measurements will be taken.
  • Participants will be asked to answer questionnaires (diet, growth, and others)
  • At visit 2, participants will have their blood pressure measured using a 24 hour blood pressure monitor.
  • At visit 3, participants will participate in a single session of either aerobic or isometric exercise. They will wear a 24-hour blood pressure monitor immediately after the exercise session.

Study Overview

Detailed Description

Our approach to testing our working hypotheses will be to enroll children ages 13 to <18 years of age. Children will be divided equally into two groups (aerobic exercise and isometric exercise groups), with 18 children in each group. Children who meet inclusion criteria will be asked to attend three study visits at the Arkansas Children's Nutrition Center (ACNC). Resting and 24-hour ambulatory blood pressure measurements will be conducted twice during the study: baseline measurement at visit 2 and after a single session of exercise at visit 3. To accommodate for any potential dropouts post-assignment and to maintain an even distribution of participants between groups (n =18 each), the study will enroll up to n = 45 children (Refer to the Data Analysis and Randomization section for more details).

The study will follow a randomized parallel group design and will be conducted by the Physical Activity Core - Arkansas Children's Nutrition Center (ACNC) / Arkansas Children's Research Institute in collaboration with the Hypertension Clinic - Nephrology Division at the Arkansas Children Hospital (ACH). Measurements will be completed within four weeks of enrollment. Research staff involved in study procedures are or will be properly trained. All assessments may be repeated if/when needed, and if the participant is willing. Study visits may last up to 3 hours.

Baseline characteristics such as socioeconomic status, pubertal stage, dietary quality, physical fitness (aerobic capacity, body composition) and metabolic phenotyping (glucose, insulin, lipids, etc.) will be used to control for baseline covariates as described in the Data analysis Section.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Nutrition Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • Age 13 to less than 18 years old.
  • Excessive weight: BMI percentile ≥ 85th percentile.

Exclusion Criteria

  • Asthma that requires daily use of inhalers to keep symptoms under control
  • Asthma that requires use of rescue inhalers (e.g., albuterol) >2 days per week
  • Exercise induced asthma
  • Autism spectrum disorder (e.g., Autistic disorder, Rett disorder, Asperger disorder, childhood disintegrative disorder, pervasive developmental disorder not otherwise specified (PDD-NOS)
  • Attention deficit hyperactivity disorder (ADHD) treated with medication or unwillingness to discontinue medication 1 day prior to the study visit and during ambulatory blood pressure monitoring.
  • Oppositional defiant disorder (ODD)
  • Epilepsy
  • Cancer
  • Chronic kidney disease
  • Autoimmune diseases (e.g., lupus, thyroiditis, juvenile idiopathic arthritis)
  • Bleeding disorders (e.g., hemophilia)
  • Chronic infections (e.g., HIV, hepatitis B, hepatitis C)
  • Type 2 and type 1 diabetes mellitus.
  • Other pre-existing medical conditions or medications as determined by the investigators to affect the outcomes of interest.
  • Parent/participant refusal to have blood drawn
  • Unwillingness to wear a 24-hour ambulatory blood pressure monitor.
  • Hypertension managed with medication
  • Allergy to latex

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aerobic Exercise
After baseline 24-hour blood pressure measurements are taken at visit 2, participants will attend a final study visit where they will engage in a single session of aerobic exercise. The exercise routines will include 5 to 10-minute warm-up and cool-down periods, along with a 30-minute workout. Twenty-four hour blood pressure measurements will be taken after the exercise bout.
After baseline 24-hour blood pressure measurements are taken at visit 2, participants will attend a final study visit where they will engage in a single session of aerobic exercise. The exercise routines will include 5 to 10-minute warm-up and cool-down periods, along with a 30-minute workout. Twenty-four hour blood pressure measurements will be taken after the exercise bout.
Experimental: Isometric Exercise
After baseline 24-hour blood pressure measurements are taken at visit 2, participants will attend a final study visit where they will engage in a single session of isometric exercise. The exercise routines will include 5 to 10-minute warm-up and cool-down periods, along with a 30-minute workout. Twenty-four hour blood pressure measurements will be taken after the exercise bout.
After baseline 24-hour blood pressure measurements are taken at visit 2, participants will attend a final study visit where they will engage in a single session of isometric exercise. The exercise routines will include 5 to 10-minute warm-up and cool-down periods, along with a 30-minute workout. Twenty-four hour blood pressure measurements will be taken after the exercise bout.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean (24-hour) systolic and diastolic blood pressure
Time Frame: Within 4 weeks after enrollment: at visits 2 and 3
The 24-hour average of systolic and diastolic blood pressure will be calculated from data collected using ambulatory blood pressure monitoring.
Within 4 weeks after enrollment: at visits 2 and 3
Mean systolic and diastolic blood pressure during sleep
Time Frame: Within 4 weeks after enrollment: at visits 2 and 3
The mean systolic and diastolic blood pressure during sleep will be calculated from data collected using ambulatory blood pressure monitoring.
Within 4 weeks after enrollment: at visits 2 and 3
Mean systolic and diastolic blood pressure during the awake period
Time Frame: Within 4 weeks after enrollment: at visits 2 and 3
The mean systolic and diastolic blood pressure during the awake period will be calculated from data collected using ambulatory blood pressure monitoring.
Within 4 weeks after enrollment: at visits 2 and 3
Nocturnal dipping pattern
Time Frame: Within 4 weeks after enrollment: at visits 2 and 3
Nocturnal dipping pattern will be calculated as follows: Percent day- night BP difference
Within 4 weeks after enrollment: at visits 2 and 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Eva C Diaz, Arkansas Children's Nutrition Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2024

Primary Completion (Actual)

December 5, 2025

Study Completion (Actual)

December 5, 2025

Study Registration Dates

First Submitted

May 23, 2024

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 5, 2024

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 10, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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