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

Not Applicable
Recruiting
Conditions
Adolescent Obesity
Overweight and Obesity
High Blood Pressure
Exercise
Interventions
Other: Aerobic exercise
Other: Isometric exercise
Registration Number
NCT06444464
Lead Sponsor
Arkansas Children's Hospital Research Institute
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 diagnosed with high blood pressure 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.

Detailed Description

Our approach to testing our working hypotheses will be to enroll children ages 13 to 17.5 years with confirmed diagnosis of HBP. 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 50-minute 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
45
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Aerobic ExerciseAerobic exerciseAfter 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.
Isometric ExerciseIsometric exerciseAfter 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.
Primary Outcome Measures
NameTimeMethod
Mean (24-hour) systolic and diastolic blood pressureWithin 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.

Mean systolic and diastolic blood pressure during sleepWithin 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.

Mean systolic and diastolic blood pressure during the awake periodWithin 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.

Nocturnal dipping patternWithin 4 weeks after enrollment: at visits 2 and 3

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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Arkansas Children's Nutrition Center

🇺🇸

Little Rock, Arkansas, United States

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