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

NCT06444464 | Completed

• 2 other identifiers: 276902P20GM109096
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Overweight and Obesity; Adolescent Obesity; Exercise

Outcome Measures

Primary Outcomes (4)

• Mean (24-hour) systolic and diastolic blood pressure

  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

  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

  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

  Nocturnal dipping pattern will be calculated as follows: Percent day- night BP difference

  Within 4 weeks after enrollment: at visits 2 and 3

Study Arms (2)

Aerobic Exercise

ACTIVE COMPARATOR

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.

Other: Aerobic exercise

Isometric Exercise

EXPERIMENTAL

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.

Other: Isometric exercise

Interventions

Aerobic exercise OTHER

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.

Aerobic Exercise

Isometric exercise OTHER

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.

Isometric Exercise

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of General Medical Sciences (NIGMS): collaborator
• Arkansas Children's Hospital Research Institute: lead

Study Sites (1)

Arkansas Children's Nutrition Center

Little Rock, Arkansas, 72202, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Pediatric Obesity; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Eva C Diaz

  Arkansas Children's Nutrition Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: June 5, 2024
• Study Start: October 15, 2024
• Primary Completion: December 5, 2025
• Study Completion: December 5, 2025
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)