RecruitingNot ApplicableNCT05359991

Exercise in Child Health

Revamping Exercise Assessments in Child Health (Project REACH)


Sponsor

University of California, Irvine

Enrollment

240 participants

Start Date

Nov 12, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 10 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is examining exercise capacity and fitness in children and teenagers aged 10 to 17 who have Sickle Cell Disease (SCD), Cystic Fibrosis (CF), or a history of COVID-19 infection. Healthy children without these conditions will also participate as a comparison group. The goal is to better understand how these conditions affect physical fitness and whether safe exercise programs can help. You may be eligible if... - Your child is between 10 and 17 years old (Tanner stages 1-5) - Your child has a confirmed diagnosis of Sickle Cell Disease or Cystic Fibrosis, OR is a healthy volunteer OR has had documented COVID-19 - Your child's doctor has confirmed they are well enough to participate and perform exercise testing You may NOT be eligible if... - Your child has complications from their condition that make exercise unsafe - Your child has another disease or disability that would prevent them from participating in physical activity - For Cystic Fibrosis: lung function (FEV1) is below 40% of predicted, or there is active infection with Burkholderia cenocepacia or Mycobacterium abscessus - Your child is being treated for substance or alcohol abuse Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERExercise

Cardiopulmonary Exercise Testing (CPET) will be used with Multiple Brief Exercise Bouts (MBEB) in order to obtain the necessary data to yield information on the study outcome variables


Locations(1)

University of California, Irvine

Irvine, California, United States

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NCT05359991


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