Exercise in Child Health (Project REACH)
Cystic Fibrosis, Sickle Cell Disease, SARS CoV 2 Infection
About this trial
This is an interventional basic science trial for Cystic Fibrosis
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
Sites / Locations
- University of California, IrvineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Experimental
Experimental
Experimental
Healthy Controls
Children With Documented History of SARS CoV-2 Infection
Children With Sickle Cell Disease (SCD)
Children With Cystic Fibrosis (CF)
Cardiopulmonary Exercise Test (CPET) will be performed to measure cardiorespiratory responses in healthy controls. Exercise will consist of up to 8, 2 minutes bouts of constant work rate cycle ergometry with 1 minute resting intervals between each exercise bout. A subgroup of children will be asked to allow the investigators to obtain blood samples during the exercise session. The following procedures will occur: The child will be in a fasted state. An IV will be placed into the child's arm. Blood sampling will be taken at 4 time points; baseline, and the end of exercise, and at 30 and 60 minutes post exercise.
Cardiopulmonary Exercise Test (CPET) will be performed to measure cardiorespiratory responses in children with a documented history of SARS CoV-2 Infection. Exercise will consist of up to 8, 2 minutes bouts of constant work rate cycle ergometry with 1 minute resting intervals between each exercise bout. A subgroup of children will be asked to allow the investigators to obtain blood samples during the exercise session. The following procedures will occur: The child will be in a fasted state. An IV will be placed into the child's arm. Blood sampling will be taken at 4 time points; baseline, and the end of exercise, and at 30 and 60 minutes post exercise.
Cardiopulmonary Exercise Test (CPET) will be performed to measure cardiorespiratory responses in children with Children With Sickle Cell Disease (SCD). Exercise will consist of up to 8, 2 minutes bouts of constant work rate cycle ergometry with 1 minute resting intervals between each exercise bout. A subgroup of children will be asked to allow the investigators to obtain blood samples during the exercise session. The following procedures will occur: The child will be in a fasted state. An IV will be placed into the child's arm. Blood sampling will be taken at 4 time points; baseline, and the end of exercise, and at 30 and 60 minutes post exercise.
Cardiopulmonary Exercise Test (CPET) will be performed to measure cardiorespiratory responses in children with Children With Cystic Fibrosis (CF). Exercise will consist of up to 8, 2 minutes bouts of constant work rate cycle ergometry with 1 minute resting intervals between each exercise bout. A subgroup of children will be asked to allow the investigators to obtain blood samples during the exercise session. The following procedures will occur: The child will be in a fasted state. An IV will be placed into the child's arm. Blood sampling will be taken at 4 time points; baseline, and the end of exercise, and at 30 and 60 minutes post exercise.