Exercise in Child Health

Launched by UNIVERSITY OF CALIFORNIA, IRVINE · Apr 28, 2022

Keywords

ClinConnect Summary

The "Exercise in Child Health" clinical trial is studying how children with certain chronic illnesses—like cystic fibrosis, sickle cell disease, and those who have had SARS-CoV-2 infections—respond to exercise. The goal is to understand how to safely and effectively encourage physical activity in these children, as traditional exercise tests are often designed for healthy athletes and may not apply to them. Over a period of 3 to 4 years, researchers will work with children aged 10 to 17 from various locations to measure their exercise responses. This information will help create better guidelines for physical activity that can improve their health and well-being.

To be eligible for the study, children must be between 10 and 17 years old and diagnosed with cystic fibrosis or sickle cell disease, or they should have a history of SARS-CoV-2 infection. They need to be in relatively good health, with no serious complications from their condition, and have permission from their doctor to participate. Participants can expect to engage in exercise assessments and help researchers understand how exercise impacts their health. This important study could lead to new tools for doctors and researchers to help children with these conditions stay active and healthy.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Sickle Cell Disease
• • Tanner 1-5, corresponding approximately to ages 10-17 y/o
• • SCD diagnosis including all relevant genotypes
• • Determined to be in relatively good health as a patient with SCD with no complications from SCD that would render participation the study unadvisable
• • No evidence of other disease or disability that would impair participation in PA
• • Physician permission to perform CPET
• • BMI within the average range for age and condition
• • Cystic Fibrosis
• • Confirmed diagnosis of CF based on either two CF-causing mutations and/or a sweat chloride concentration of \> 60 mmol/l after a positive newborn screening test or on two separate occasions
• • Tanner 1-5 corresponding approximately to ages 10-17 y/o as documented by a licensed independent provider at screening, or by a validated self-assessment tool
• • Determined to be in relatively good health as a patient with CF with no complications from CF that would render participation the study unadvisable as determined by a physician. Examples include history of submassive or massive hemoptysis or moderate to severe pulmonary hypertension.
• • BMI in the average range for age and condition
• • No evidence of other disease or disability that would impair participation in PA
• • Comparison (Healthy control)
• • Tanner 1-5 corresponding approximately to ages 10-17 y/o
• • Determined to be in good health by pre-participation history and physical examination performed by primary care providers or PERC staff
• • BMI and PA participation (by history) in the average range for age
• • No evidence of disease or disability that would impair participation in PA
• • Comparison (SARS-CoV-2)
• • Tanner 1-5 corresponding approximately to ages 10-17 y/o
• • Documented SARS-CoV-2 infection
• • Capable of doing exercise as determined by primary care providers or PERC a medical officer
• Exclusion Criteria:
• • Sickle Cell Disease Treatment for substance or alcohol abuse
• • Requiring chronic monthly transfusions
• • Other conditions that preclude exercise such as neuromotor disease, heart disease, or any other condition that would prevent a child from participating in PA
• • Cystic Fibrosis Treatment for substance or alcohol abuse
• • Other conditions that preclude exercise (such as neuromotor disease, heart disease, or any other condition that would prevent a child from participating in PA)
• • FEV1 \< 40% predicted based on Global Lung Index equations
• • Current infection with Burkholderia cenocepacia or Mycobacterium abscessus
• • Comparison (Healthy control) Treatment for substance or alcohol abuse or chronic medication use • Determination by PERC staff of unsuitability for exercise
• • Comparison (SARS-CoV-2) Treatment for substance or alcohol abuse or chronic medication use
• • • Determination by PERC staff of unsuitability for exercise