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Exercise in Child Health

Revamping Exercise Assessments in Child Health (Project REACH)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years to 17 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests new ways to measure how children's bodies respond to exercise. It is for children about ages 10–17 with sickle cell disease, cystic fibrosis, or a past COVID-19 infection, and healthy children for comparison. The goal is to improve exercise testing for children with long-term health conditions.

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). There is an increasing number of children who, through medical advances, now survive diseases and conditions that were once fatal, but which remain chronic and debilitating. A major challenge to improve both the immediate and long term care and health of such children has been the gap in our understanding of how to assess the biological effects of exercise. Like otherwise healthy children, children with chronic diseases and disabilities want to be physically active. The challenge is to determine what constitutes safe and beneficial level of physical activity when the underlying disease or condition \[e.g., cystic fibrosis (CF) or sickle cell disease (SCD)\] imposes physiological constraints on exercise that are not present in otherwise healthy children. Current exercise testing protocols were based on studies of athletes and high performing healthy individuals and were designed to test limits of performance at very high-intensity, unphysiological, maximal effort. These approaches are not optimal for children and adolescents with disease and disability. This project (REACH-Revamping Exercise Assessment in Child Health) is designed to address this gap. Cohorts of children will be identified with two major genetic diseases (CF and SCD) and measure exercise responses annually as they progress from early puberty to mid or late puberty over a 3-4year period. In addition, in the light of the pandemic, a group of children will be added who were affected by SARS-CoV-2 and investigate their responses to exercise. SARS-CoV-2 has similar long-term symptoms than CF and SCD have. Novel approaches to assessing physiological responses to exercise using advanced data analytics will be examined in relation to metrics of habitual physical activity, circulating biomarkers of inflammation and growth, leukocyte gene expression, and the impact of the underlying CF, SCD or SARS-CoV-2 condition. The data from this study will help to develop a toolkit of innovative metrics for exercise testing that will be made available to the research and clinical community.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • All groups: Be about ages 10–17 and meet the study's stage-of-growth requirements.
  • Sickle cell group: Have sickle cell disease, an inherited blood disease. Be well enough to join and have a doctor's permission for exercise testing.
  • Cystic fibrosis group: Have cystic fibrosis, an inherited disease that affects the lungs and other organs, confirmed by the required gene or sweat tests.
  • Cystic fibrosis group: A doctor must decide that your health and any disease complications allow you to join.
  • Sickle cell, cystic fibrosis, and healthy groups: Have a BMI, a measure of weight compared with height, in the average range for your age and condition.
  • Sickle cell, cystic fibrosis, and healthy groups: Have no other disease or disability that would limit physical activity.
  • Healthy group: Be in good health based on a health history and exam, with an average activity level for your age.
  • COVID-19 group: Have a documented COVID-19 infection and be able to exercise, as judged by a medical provider.

Who can't join

  • All groups: Be receiving treatment for drug or alcohol abuse.
  • Sickle cell group: Need regular monthly blood transfusions.
  • Sickle cell or cystic fibrosis group: Have another condition that prevents exercise, such as heart disease or a disease affecting nerves and muscles.
  • Cystic fibrosis group: Have an FEV1 below 40% of the expected value. This test measures how much air you can blow out in one second.
  • Cystic fibrosis group: Have a current infection with either of two bacteria: Burkholderia cenocepacia or Mycobacterium abscessus.
  • Healthy or COVID-19 group: Use medicine on a long-term basis.
  • Healthy or COVID-19 group: Study staff decide exercise is not suitable for you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

CA