RECRUITING

Exercise in Child Health

Conditions

Cystic Fibrosis Sickle Cell Disease SARS CoV 2 Infection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Revamping Exercise Assessments in Child Health (Project REACH)

Quick Facts

Study Start:2020-11-12

Study Completion:2024-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05359991

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.

Ages Eligible for Study:10 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* 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 * 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 * 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 * 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	* 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 * 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

Inclusion Criteria

Exclusion Criteria

* 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
* 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
* 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
* 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

* 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
* 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

Contacts and Locations

Study Contact

Peter Horvath, Ph.D.

CONTACT

(714) 456-8248

phorvath@hs.uci.edu

Study Locations (Sites)

University of California, Irvine

Irvine, California, 92697

United States

Collaborators and Investigators

Sponsor: University of California, Irvine

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

Study Start Date2020-11-12

Study Completion Date2024-06

Study Record Updates

Study Start Date2020-11-12

Study Completion Date2024-06

Terms related to this study

Additional Relevant MeSH Terms

Cystic Fibrosis
Sickle Cell Disease
SARS CoV 2 Infection