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New treatment option for Cystic Fibrosis
Official title Exercise in Child Health
ClinicalTrials.gov ID: NCT05359991
What this study is testing
- What it's testing
- 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).
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 17. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- Other conditions that preclude exercise (such as neuromotor disease, heart disease, or any other condition that would prevent a child from...
- 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...
See the full eligibility 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...
- 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
- 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...
- Determination by PERC staff of unsuitability for exercise
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 17 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.