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Exercise for Chronic Pediatric Conditions (Project REACH Trial)

N/A
Recruiting
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Sickle Cell Disease: Tanner 1-5, corresponding approximately to ages 10-17 y/o
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months
Awards & highlights

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.

Who is the study for?
Children aged approximately 10-17 with cystic fibrosis, sickle cell disease, or past SARS-CoV-2 infection are eligible for this exercise study if they're in good health and have no other conditions that limit physical activity. They must be at a stage of puberty as defined by Tanner stages 1-5 and have physician approval to perform exercise tests.Check my eligibility
What is being tested?
The REACH project is testing how children with chronic diseases respond to exercise. It aims to develop new ways of measuring the effects of physical activity on kids with genetic diseases like cystic fibrosis and sickle cell disease, as well as those affected by COVID-19.See study design
What are the potential side effects?
Since the intervention involves exercise, potential side effects may include typical responses such as muscle soreness or fatigue. However, specific risks might vary based on each child's condition and will be monitored closely.

Project REACH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have sickle cell disease and am between 10 to 17 years old.
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I have been diagnosed with Cystic Fibrosis based on genetic tests or sweat chloride levels.
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I am between 10 and 17 years old.
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I am healthy with no illness or disability that limits my physical activity.
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My BMI is average for my age and sickle cell condition.
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I have been diagnosed with Sickle Cell Disease.
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I have cystic fibrosis but no other conditions that limit my physical activity.
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My doctor has approved a CPET for my sickle cell disease.
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I am between 10 to 17 years old with Cystic Fibrosis, as confirmed by a healthcare provider.
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I have Sickle Cell Disease but am in good health with no major complications.
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I have sickle cell disease but no other condition that limits my physical activity.
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My BMI is average for someone with Cystic Fibrosis.
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I am between 10 and 17 years old.

Project REACH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
% Body Fat
Biomarkers
Fat Mass
+6 more
Secondary outcome measures
Behavioral responses to exercise
Standardized assessments

Project REACH Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Children With Sickle Cell Disease (SCD)Experimental Treatment1 Intervention
Cardiopulmonary Exercise Test (CPET) will be performed to measure cardiorespiratory responses in children with Children With Sickle Cell Disease (SCD). Exercise will consist of up to 8, 2 minutes bouts of constant work rate cycle ergometry with 1 minute resting intervals between each exercise bout. A subgroup of children will be asked to allow the investigators to obtain blood samples during the exercise session. The following procedures will occur: The child will be in a fasted state. An IV will be placed into the child's arm. Blood sampling will be taken at 4 time points; baseline, and the end of exercise, and at 30 and 60 minutes post exercise.
Group II: Children With Documented History of SARS CoV-2 InfectionExperimental Treatment1 Intervention
Cardiopulmonary Exercise Test (CPET) will be performed to measure cardiorespiratory responses in children with a documented history of SARS CoV-2 Infection. Exercise will consist of up to 8, 2 minutes bouts of constant work rate cycle ergometry with 1 minute resting intervals between each exercise bout. A subgroup of children will be asked to allow the investigators to obtain blood samples during the exercise session. The following procedures will occur: The child will be in a fasted state. An IV will be placed into the child's arm. Blood sampling will be taken at 4 time points; baseline, and the end of exercise, and at 30 and 60 minutes post exercise.
Group III: Children With Cystic Fibrosis (CF)Experimental Treatment1 Intervention
Cardiopulmonary Exercise Test (CPET) will be performed to measure cardiorespiratory responses in children with Children With Cystic Fibrosis (CF). Exercise will consist of up to 8, 2 minutes bouts of constant work rate cycle ergometry with 1 minute resting intervals between each exercise bout. A subgroup of children will be asked to allow the investigators to obtain blood samples during the exercise session. The following procedures will occur: The child will be in a fasted state. An IV will be placed into the child's arm. Blood sampling will be taken at 4 time points; baseline, and the end of exercise, and at 30 and 60 minutes post exercise.
Group IV: Healthy ControlsActive Control1 Intervention
Cardiopulmonary Exercise Test (CPET) will be performed to measure cardiorespiratory responses in healthy controls. Exercise will consist of up to 8, 2 minutes bouts of constant work rate cycle ergometry with 1 minute resting intervals between each exercise bout. A subgroup of children will be asked to allow the investigators to obtain blood samples during the exercise session. The following procedures will occur: The child will be in a fasted state. An IV will be placed into the child's arm. Blood sampling will be taken at 4 time points; baseline, and the end of exercise, and at 30 and 60 minutes post exercise.

Find a Location

Who is running the clinical trial?

Children's Hospital of Orange CountyOTHER
32 Previous Clinical Trials
4,694 Total Patients Enrolled
Ann & Robert H Lurie Children's Hospital of ChicagoOTHER
253 Previous Clinical Trials
5,187,488 Total Patients Enrolled
Children's Hospital Los AngelesOTHER
230 Previous Clinical Trials
5,076,202 Total Patients Enrolled

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT05359991 — N/A
Sickle Cell Disease Research Study Groups: Children With Documented History of SARS CoV-2 Infection, Children With Cystic Fibrosis (CF), Children With Sickle Cell Disease (SCD), Healthy Controls
Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT05359991 — N/A
Sickle Cell Disease Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT05359991 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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)."

Answered by AI

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."

Answered by AI
Recent research and studies
~6 spots leftby May 2024