Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06444464
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-23
Brief Title:
The BEE-Power Study Boosting Exercise for Excellent Pediatric Blood Pressure
Sponsor:
Arkansas Childrens Hospital Research Institute
Organization:
Arkansas Childrens Hospital Research Institute
Study Overview
Official Title:
The BEE-Power Study Boosting Exercise for Excellent Pediatric Blood Pressure
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 175 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
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 175 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 Childrens 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 Childrens Nutrition Center ACNC Arkansas Childrens 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 ifwhen 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
The study will follow a randomized parallel group design and will be conducted by the Physical Activity Core - Arkansas Childrens Nutrition Center ACNC Arkansas Childrens 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 ifwhen 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None