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New study aims to make exercise safer for kids with cystic fibrosis, sickle cell, and long COVID
NCT ID NCT05359991
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is working to create better exercise tests for children with cystic fibrosis, sickle cell disease, or long COVID. Current tests are designed for healthy athletes and may not be safe or useful for these kids. Researchers will track 240 children over 3-4 years, measuring their breathing, heart rate, body composition, and activity levels to develop new testing guidelines.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could lead to safer and more accurate exercise guidelines for children with chronic diseases, helping them stay active without harm.
- What could go wrong
- This is an observational study, not a treatment trial. It will not directly improve health, and results may take years to apply in practice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2020
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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10 to 17 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of California, Irvine
RECRUITINGIrvine, California, 92697, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a simple questionnaire reveal why some cystic fibrosis patients skip physiotherapy?
- Gene editing offers hope for a One-Time sickle cell cure
- Can a pill stop COVID-19 before it starts?
- Cystic fibrosis diabetes: do gut hormones and genes hold the key?