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Exercise for Chronic Pediatric Conditions (Project REACH Trial)
Project REACH Trial Summary
This trial is testing how well different types of exercise work for children with chronic diseases or conditions, like cystic fibrosis or sickle cell disease, that were once fatal but now remain chronic and debilitating.
Project REACH Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowProject REACH Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Project REACH Trial Design
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Who is running the clinical trial?
Media Library
- I have sickle cell disease and am between 10 to 17 years old.I have been diagnosed with Cystic Fibrosis based on genetic tests or sweat chloride levels.I am receiving treatment for substance or alcohol abuse, or I use chronic medication.I am between 10 and 17 years old.I am healthy with no illness or disability that limits my physical activity.PERC staff will decide if you are not fit for exercise because of SARS-CoV-2.I have cystic fibrosis and am currently infected with either Burkholderia cenocepacia or Mycobacterium abscessus.My BMI is average for my age and sickle cell condition.I have been diagnosed with Sickle Cell Disease.I am receiving treatment for substance or alcohol abuse.You have a confirmed case of SARS-CoV-2 infection.You have a history of substance or alcohol abuse, or you are taking chronic medications. The study team has determined that you are not suitable for the exercise.You are able to exercise as determined by your primary care provider or a medical officer.I have cystic fibrosis but no other conditions that limit my physical activity.My doctor has approved a CPET for my sickle cell disease.I am between 10 to 17 years old with Cystic Fibrosis, as confirmed by a healthcare provider.I have Sickle Cell Disease but am in good health with no major complications.I have sickle cell disease but no other condition that limits my physical activity.My BMI is average for someone with Cystic Fibrosis.I am receiving treatment for substance or alcohol abuse.I am between 10 and 17 years old.People in the comparison group should have a healthy body weight and be physically active on a regular basis for their age.I have a condition that prevents me from doing physical activities.My lung function is less than 40% of what is expected for my age and height.I need monthly blood transfusions for my sickle cell disease.I have Cystic Fibrosis but no other conditions that stop me from exercising.
- Group 1: Children With Documented History of SARS CoV-2 Infection
- Group 2: Children With Cystic Fibrosis (CF)
- Group 3: Children With Sickle Cell Disease (SCD)
- Group 4: Healthy Controls
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
How many participants are involved with this trial's research?
"Affirmative, the clinicaltrial.gov portal indicates that this research is actively recruiting subjects. Initially posted on May 15th 2022 and modified April 28th of the same year, 240 participants are required from a single facility."
Are there any open slots for this research project?
"As of right now, this clinical trial is actively recruiting. The study was posted on May 15th 2022 and recently updated on April 28th 2022 per the information shared by clinicaltrials.gov."
What are the qualifications for participating in this research endeavor?
"This clinical trial seeks to enroll 240 young people suffering from cystic fibrosis aged 10-17. The essential criteria for admission includes: Tanner 1-5, diagnosis of SCD including related genotypes, overall health with no complications that could interfere with the study protocol, BMI in line with age and condition parameters, confirmed CF through newborn screening or two separate tests showing mutations associated with CF as well as sweat chloride concentration >60 mmol/l., self-assessment tool validation by licensed independent provider at screening , and Sickle cell Disease (SCD)."
Does this research study accept participants of under 45 years?
"Prospective participants must be aged between 10 and 17 years old. Currently, there are 336 trials for minors and 1099 studies for individuals who are 65 or older."
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