Exercise in Child Health

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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:

🦠 Cystic Fibrosis 🦠 Sickle Cell Disease 🦠 SARS CoV 2 Infection

🗓️ Study Start (Actual) 12 November 2020

🗓️ Primary Completion (Estimated) May 2024

✅ Study Completion (Estimated) June 2024

👥 Enrollment (Estimated) 240

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Irvine, California, United States

📋 Eligibility Criteria

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

Ages Eligible for Study: 10 Years to 17 Years (CHILD)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: Yes

🗓️ 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 Registration Dates

First Submitted 31 March 2022
First Submitted that Met QC Criteria 28 April 2022
First Posted 4 May 2022

Study Record Updates

Last Update Submitted that Met QC Criteria 12 March 2024
Last Update Posted 15 March 2024
Last Verified March 2024