Status:
RECRUITING
Exercise in Child Health
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
Children's Hospital of Orange County
Children's Hospital Los Angeles
Conditions:
Cystic Fibrosis
Sickle Cell Disease
Eligibility:
All Genders
10-17 years
Phase:
NA
Brief Summary
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...
Detailed Description
New, generalizable approaches are needed for measuring physical fitness and activity across a spectrum of pediatric health and disease. Exercise in children and adolescents is not merely play but is ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05359991
Start Date
November 12 2020
End Date
January 1 2026
Last Update
July 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California, Irvine
Irvine, California, United States, 92697