💬In plain words
What the trial is, and whether it could suit you
This study is a cooperative investigation funded by the NIH. The project is a collaboration among three major NIH Clinical Translational Science Awardees: 1) UCI (lead site with its affiliate CHOC), 2) Northwestern University (with its affiliate Lurie Children's Hospital), and 3) USC (with its affiliate Children's Hospital of Los Angeles).
There is an increasing number of children who, through medical advances, now survive diseases and conditions that were once fatal, but which remain chronic and debilitating. A major challenge to improve both the immediate and long term care and health of such children has been the gap in our understanding of how to assess the biological effects of exercise. Like otherwise healthy children, children with chronic diseases and disabilities want to be physically active. The challenge is to determine what constitutes safe and beneficial level of physical a
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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