Recruiting

Exercise

Sponsor:

UCLA

Code:

NCT05359991

Conditions

Cystic Fibrosis

Sickle Cell Disease

SARS CoV 2 Infection

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Accepted

Interventions

Exercise

Study Details

Brief summary:

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 ID

NCT05359991

Start date

Nov 12, 2020

Status verified date

Jan, 2026

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 17

Healthy Volunteers: Accepted

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 Design

Enrollment

240 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

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.

Interventions

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

Primary outcome measure

  • Gas Exchange Variables [ Time Frame: 8 Months ]
  • Whole Body Lean Mass [ Time Frame: 8 Months ]
  • Physical Activity [ Time Frame: 8 Months ]
  • Biomarkers [ Time Frame: 8 Months ]
  • Gene Expression [ Time Frame: 8 Months ]
  • Gas Exchange Variables [ Time Frame: 8 Months ]
  • Gas Exchange Variables [ Time Frame: 8 Months ]
  • Gas Exchange Variables [ Time Frame: 8 Months ]
  • Gas Exchange Variables [ Time Frame: 8 Months ]
  • Gas Exchange Variables [ Time Frame: 8 Months ]
  • Gas Exchange Variables [ Time Frame: 8 Months ]
  • Fat Mass [ Time Frame: 8 Months ]
  • % Body Fat [ Time Frame: 8 Months ]
  • Whole Body Bone Mineral Content [ Time Frame: 8 Months ]
  • Whole Body Bone Mineral Density [ Time Frame: 8 Months ]
  • Biomarkers [ Time Frame: 8 Months ]
  • Biomarkers [ Time Frame: 8 Months ]
  • Biomarkers [ Time Frame: 8 Months ]
  • Biomarkers [ Time Frame: 8 Months ]
  • Biomarkers [ Time Frame: 8 Months ]
  • Biomarkers [ Time Frame: 8 Months ]
  • Biomarkers [ Time Frame: 8 Months ]
  • Gene Expression [ Time Frame: 8 Months ]
  • Gene Expression [ Time Frame: 8 Months ]

Central Contacts and Locations

Central contacts

Peter Horvath, Ph.D.

(714) 456-8248phorvath@hs.uci.edu

Locations

University of California, Irvine

Recruiting

Irvine, California, United States, 92697

Contacts

Shlomit Radom-Aizik, Ph.D.

(949) 824-2584saizik@hs.uci.edu

Dan Cooper, M.D.

(949) 824-1923dcooper@hs.uci.edu

More Information

Sponsor

University of California, Irvine

Last update posted

Mar 24, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-03-24.