Exploring the effects of exercise on children's health with chronic diseases
Official title: Revamping Exercise Assessments in Child Health (Project REACH)
Run by University of California, Irvine · NCT05359991 · Data updated 2026-11-12
This study is testing how exercise can improve the health of children with chronic diseases like cystic fibrosis and sickle cell disease to find safe ways for them to be active.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 10 Years to 17 Years |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | University of California, Irvine Academic / other |
| Locations | 1 site (Irvine, California) |
| Status | Recruiting |
| Started | November 12, 2020 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT05359991 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 10-17 with a diagnosis of cystic fibrosis or sickle cell disease who are in relatively good health.
✕Probably not a fit
Patients with significant complications from cystic fibrosis or sickle cell disease, or those with other disabilities that impair participation in physical activity, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This investigation focuses on understanding the biological effects of exercise in children with chronic conditions such as cystic fibrosis and sickle cell disease. The study aims to establish safe and beneficial levels of physical activity for these children, recognizing the importance of physical activity in their growth and overall health. It is a collaborative effort among three major NIH Clinical Translational Science Awardees, utilizing a comprehensive approach to measure physical fitness and activity across various pediatric health scenarios. The study will involve exercise interventions and assessments to gather data on the impact of physical activity on health outcomes.
Why it matters
Potential benefit: If successful, this study could lead to improved health outcomes and quality of life for children with chronic diseases through tailored exercise programs.
How similar studies have gone: Other studies have shown promise in exploring the benefits of exercise in pediatric populations with chronic conditions, indicating that this approach is both relevant and potentially impactful.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University of California, Irvine
Irvine, California, United States Recruiting
Study contacts
- Study coordinator: Peter Horvath, Ph.D.
- Email: phorvath@hs.uci.edu
- Phone: (714) 456-8248
Similar studies
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Newborn Sickle Cell Screening in Mozambique
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.