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

Overweight and Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06444464
• Other study ID #: 276902
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2024
• Source: Arkansas Children's Hospital Research Institute
• Contact: Eva C Diaz, M.D.
• Phone: 5013643056
• Email: ecdiazfuentes[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: June 30, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

Inclusion Criteria

• Age 13 to 17.5 years old
• Excessive weight: BMI percentile = 85th and <140% of the 95th percentile or BMI
• 35 to <40 kg/m2
• Diagnosis of HBP
• HBP treated with lifestyle modifications only Exclusion Criteria
• Children with class 3 obesity (i.e., BMI = 140% of the 95th percentile or BMI = 40.0 kg/m2)
• 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)
• Oppositional defiant disorder (ODD)
• Epilepsy
• Cancer
• Chronic kidney disease
• Hormonal disease (e.g., hypothyroidism and growth hormone deficiency)
• 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

Related Conditions & MeSH terms

• Adolescent Obesity
• Exercise
• High Blood Pressure
• Hypertension
• Obesity
• Overweight
• Overweight and Obesity
• Pediatric Obesity

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Arkansas Children's Nutrition Center	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic and diastolic blood pressure in the resting state	Resting measurements will be recorded in the research facility for 2 consecutive hours at visit 2 and before the exercise bout at visit 3	Within 4 weeks after enrollment: at visits 2 and 3
Primary	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
Primary	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
Primary	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
Primary	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