Actively Recruiting

Phase Not Applicable
Age: 10Years - 17Years
All Genders
Healthy Volunteers
NCT05359991

Exercise in Child Health

Led by University of California, Irvine · Updated on 2026-03-24

240

Participants Needed

1

Research Sites

293 weeks

Total Duration

On this page

Sponsors

U

University of California, Irvine

Lead Sponsor

C

Children's Hospital of Orange County

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Exercise in Child Health

Who Can Participate

Age: 10Years - 17Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged approximately 10 to 17 years at pubertal stages Tanner 1-5
  • Diagnosed with sickle cell disease including all genotypes and in relatively good health without complications preventing exercise
  • Diagnosed with cystic fibrosis confirmed by genetic mutations or sweat test, in relatively good health without complications preventing exercise
  • Healthy children determined by physical exam and history with average BMI and physical activity
  • Children with documented SARS-CoV-2 infection capable of performing exercise as determined by a medical provider
Not Eligible

You will not qualify if you...

  • Children with sickle cell disease requiring chronic monthly transfusions or other conditions preventing exercise such as neuromotor or heart disease
  • Children with cystic fibrosis with FEV1 less than 40% predicted, current infection with specific bacteria, or other conditions preventing exercise
  • Any child with substance or alcohol abuse treatment or chronic medication use that makes exercise unsafe
  • Children deemed unsuitable for exercise by study staff or medical officers due to health reasons

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of California, Irvine

Irvine, California, United States, 92697

Actively Recruiting

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Research Team

P

Peter Horvath, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

5

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