Exercise in Child Health (Project REACH)

March 19, 2026 updated by: Dan Cooper, University of California, Irvine

Revamping Exercise Assessments in Child Health (Project REACH)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

New, generalizable approaches are needed for measuring physical fitness and activity across a spectrum of pediatric health and disease.

Exercise in children and adolescents is not merely play but is an essential component of growth and development. Children are among the most spontaneously physically active human beings. It is not surprising that participation in PA (Physical Activity) is a major determinant of health across the lifespan and health-related quality of life in both healthy children and in children with chronic diseases. Despite this essential biologic role for PA, children have not been spared the relentless reduction in levels of PA that is creating a crisis in health care in our nation and throughout the world. Recognition of the enormous morbidity and cost of physical inactivity-related diseases, such as atherosclerosis, type 2 diabetes, and osteoporosis, has spurred new policy initiatives targeting preventive medicine early in life. The concept of pediatric origins of adult health and disease is gaining scientific merit, highlighting the need to transform existing notions of how to evaluate health in a growing child. A physically inactive (even normal weight) child may have no symptoms of disease, but evidence of deterioration in vascular health may already be present. As era of population health management and precision medicine are approaching, the notion of what it means to be a healthy child must change and include robust metrics of physical fitness.

Equally worrisome is that the deleterious health effects of physical inactivity and poor fitness are exacerbated in children with chronic disease and/or disabilities or with environmental-lifestyle conditions like obesity. Children with diseases or conditions previously associated with mortality during the first two decades of life (e.g., SCD, CF) are living longer due to remarkable advances in research and care, but are often unable to achieve levels of PA and fitness associated with health benefits in otherwise healthy children. Not surprisingly, the healthspan [the period of life free from serious chronic diseases and disability of children with chronic diseases is threatened not only by the underlying disease, but by the compounding effects of insufficient PA and sedentary behavior. Increasing PA and fitness is feasible, but has proven quite challenging to implement in a systematic manner. Once a pattern of physical inactivity and a sedentary lifestyle is established, a vicious cycle ensues, in which constraints on PA harm immediate health and contribute to lifelong health impairment ranging from cardiovascular and metabolic disease to osteoporosis. Exactly what constitutes ideal physical fitness in a child with a chronic condition remains unknown. Finding beneficial levels of PA in children with chronic disease or disability is challenging because the optimal range of exercise is much narrower than in a healthy child. Finally, as a result of the COVID-19 pandemic a sizable number of children are experiencing long-term effects such as fatigue, and will be included in our study. Similar to children with CF and SCD, studies of exercise and physical activity will provide insight into disease mechanisms and possible therapies.

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92697
        • Recruiting
        • University of California, Irvine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy Controls

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.
Other: Exercise
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
Experimental: Children With Documented History of SARS CoV-2 Infection

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.
Other: Exercise
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
Experimental: Children With Sickle Cell Disease (SCD)

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.
Other: Exercise
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
Experimental: Children With Cystic Fibrosis (CF)

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.
Other: Exercise
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
Experimental: Children with Hyperlipidemia

Cardiopulmonary Exercise Test (CPET) will be performed to measure cardiorespiratory responses in children with Children with hyperlipidema (Visit 1). 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 (Visit 2). The following procedures will occur:

  • The child will be in a fasted state.
  • An IV will be placed into the child's arm.
Other: Exercise
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gas Exchange Variables
Time Frame: 8 Months
oxygen uptake
8 Months
Whole Body Lean Mass
Time Frame: 8 Months
Measured by Dual X-Ray Densitometry
8 Months
Physical Activity
Time Frame: 8 Months
Measured by Actigraphy
8 Months
Biomarkers
Time Frame: 8 Months
IGF-1
8 Months
Gene Expression
Time Frame: 8 Months
Circulating leukocyte gene expression associated with exercise
8 Months
Gas Exchange Variables
Time Frame: 8 Months
V̇O2
8 Months
Gas Exchange Variables
Time Frame: 8 Months
Carbon dioxide output
8 Months
Gas Exchange Variables
Time Frame: 8 Months
V̇CO2
8 Months
Gas Exchange Variables
Time Frame: 8 Months
ventilation
8 Months
Gas Exchange Variables
Time Frame: 8 Months
V̇E
8 Months
Gas Exchange Variables
Time Frame: 8 Months
heart rate (HR)
8 Months
Fat Mass
Time Frame: 8 Months
Measured by Dual Energy X-Ray Absorptiometry
8 Months
% Body Fat
Time Frame: 8 Months
Measured by Dual X-Ray Densitometry
8 Months
Whole Body Bone Mineral Content
Time Frame: 8 Months
Measured by Dual X-Ray Densitometry
8 Months
Whole Body Bone Mineral Density
Time Frame: 8 Months
Measured by Dual X-Ray Densitometry
8 Months
Biomarkers
Time Frame: 8 Months
IL6
8 Months
Biomarkers
Time Frame: 8 Months
C-Reactive Protein
8 Months
Biomarkers
Time Frame: 8 Months
Glucose
8 Months
Biomarkers
Time Frame: 8 Months
insulin
8 Months
Biomarkers
Time Frame: 8 Months
lipid screen
8 Months
Biomarkers
Time Frame: 8 Months
lactate
8 Months
Biomarkers
Time Frame: 8 Months
CBC
8 Months
Gene Expression
Time Frame: 8 Months
Circulating Leukocyte Gene Expression Associated with Sickle Cell Anemia
8 Months
Gene Expression
Time Frame: 8 Months
Circulating Leukocyte Gene Expression Associated with Cystic Fibrosis
8 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Behavioral responses to exercise
Time Frame: 8 Months
PROMIS Parent Fatigue Questionnaire
8 Months
Standardized assessments
Time Frame: 8 Months
TANNER Staging Questionnaire
8 Months
Behavioral responses to exercise
Time Frame: 8 Months
PROMIS Pediatric Fatigue Questionnaire
8 Months
Behavioral responses to exercise
Time Frame: 8 Months
Project REACH NHANES PAQ Adapted Questionnaire
8 Months
Behavioral responses to exercise
Time Frame: 8 Months
PEDSQL Fatigue Questionnaire
8 Months
Behavioral responses to exercise
Time Frame: 8 Months
Appendices Questionnaire
8 Months
Standardized assessments
Time Frame: 8 Months
Block Standardized FFQ
8 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Irvine

Collaborators

Ann & Robert H Lurie Children's Hospital of Chicago
Children's Hospital Los Angeles
Children's Hospital of Orange County

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2020

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

April 28, 2022

First Posted (Actual)

May 4, 2022

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000028 (20195402)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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