Actively Recruiting

Phase Not Applicable
Age: 10Years - 17Years
All Genders
Healthy Volunteers
ID05359991

Revamping Exercise Assessments in Child Health (Project REACH)

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

240

Participants Needed

1

Research Sites

N/A

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

Researchers are investigating how to better measure exercise responses in children and adolescents with chronic diseases such as cystic fibrosis (CF), sickle cell disease (SCD), and those affected by SARS-CoV-2. The study is a collaboration among several NIH Clinical Translational Science Award sites and aims to close gaps in understanding safe and beneficial physical activity levels for children with physiological constraints due to these conditions. This research focuses on developing new ways to assess physical fitness and health impacts across pediatric populations with chronic illnesses. Participants will undergo cardiopulmonary exercise testing (CPET) involving up to eight 2-minute bouts of constant work rate cycling with 1-minute rest intervals. Some children will have blood samples taken at baseline, end of exercise, and 30 and 60 minutes post-exercise to analyze biomarkers and gene expression. The study includes groups of healthy children, children with CF, SCD, SARS-CoV-2 history, and hyperlipidemia, with testing performed annually over a 3-4 year period. Throughout the study, children will be monitored for gas exchange variables, body composition measures, physical activity levels, biomarkers, gene expression, and behavioral responses to exercise. Assessments include clinical exams, questionnaires, and blood sampling to track health and fitness changes over time. Participation involves repeated visits for exercise testing and biological sample collection, helping researchers develop innovative metrics for exercise assessment in pediatric chronic disease populations. The study is expected to continue through June 2026.

CONDITIONS

Brief 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 (Tanner stages 1-5)
  • Diagnosed with sickle cell disease, cystic fibrosis, documented SARS-CoV-2 infection, hyperlipidemia, or healthy controls
  • Determined to be in relatively good health and able to perform physical activity
  • Body mass index (BMI) within the average range for age and condition
  • Physician or medical provider permission to perform cardiopulmonary exercise testing (CPET)
Not Eligible

You will not qualify if you...

  • Children requiring chronic monthly transfusions (for sickle cell disease)
  • Presence of other conditions that prevent participation in physical activity, such as neuromotor disease or heart disease
  • For cystic fibrosis, forced expiratory volume in 1 second (FEV1) below 40% predicted
  • Current infection with Burkholderia cenocepacia or Mycobacterium abscessus (for cystic fibrosis)
  • Treatment for substance or alcohol abuse
  • Chronic medication use or any condition deemed unsuitable for exercise by study staff

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Exercise

Duration - Single session

Participants perform cardiopulmonary exercise testing (CPET) involving up to 8 bouts of 2 minutes of cycle ergometry with 1 minute rest intervals to measure cardiorespiratory responses. Some participants may have an intravenous line placed for blood sampling before, during, and after exercise.

1 visit (in-person)

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.

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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Published Research Related To This Trial

Status of cardiovascular health in US adolescents: prevalence estimates from the National Health and Nutrition Examination Surveys (NHANES) 2005-2010.

Christina M Shay, Hongyan Ning, Stephen R Daniels...

https://pubmed.ncbi.nlm.nih.gov/23547177

Physical Activity Patterns of the Spanish Population Are Mostly Determined by Sex and Age: Findings in the ANIBES Study.

Juan Mielgo-Ayuso, Raquel Aparicio-Ugarriza, Adrián Castillo...

https://pubmed.ncbi.nlm.nih.gov/26914609

Association of physical activity level with depression, anxiety, and quality of life in children with type 1 diabetes mellitus.

Ebru Kaya Mutlu, Caner Mutlu, Hanifegul Taskiran...

https://pubmed.ncbi.nlm.nih.gov/26197465