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Exercise in Child Health (Project REACH)

Primary Purpose

Cystic Fibrosis, Sickle Cell Disease, SARS CoV 2 Infection

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
University of California, Irvine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cystic Fibrosis

Eligibility Criteria

10 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, IrvineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

Healthy Controls

Children With Documented History of SARS CoV-2 Infection

Children With Sickle Cell Disease (SCD)

Children With Cystic Fibrosis (CF)

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Behavioral responses to exercise
PROMIS Parent Fatigue Questionnaire
Standardized assessments
TANNER Staging Questionnaire
Behavioral responses to exercise
PROMIS Pediatric Fatigue Questionnaire
Behavioral responses to exercise
Project REACH NHANES PAQ Adapted Questionnaire
Behavioral responses to exercise
PEDSQL Fatigue Questionnaire
Behavioral responses to exercise
Appendices Questionnaire
Standardized assessments
Block Standardized FFQ

Full Information

First Posted
March 31, 2022
Last Updated
January 5, 2023
Sponsor
University of California, Irvine
Collaborators
Children's Hospital of Orange County (CHOC), Children's Hospital of Los Angeles (CHLA), Lurie Children's Hospital in Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT05359991
Brief Title
Exercise in Child Health
Acronym
Project REACH
Official Title
Revamping Exercise Assessments in Child Health (Project REACH)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 24, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Irvine
Collaborators
Children's Hospital of Orange County (CHOC), Children's Hospital of Los Angeles (CHLA), Lurie Children's Hospital in Chicago

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Sickle Cell Disease, SARS CoV 2 Infection

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Controls
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Children With Documented History of SARS CoV-2 Infection
Arm Type
Experimental
Arm Description
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.
Arm Title
Children With Sickle Cell Disease (SCD)
Arm Type
Experimental
Arm Description
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.
Arm Title
Children With Cystic Fibrosis (CF)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
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 Information:
Title
Gas Exchange Variables
Description
oxygen uptake
Time Frame
8 Months
Title
Whole Body Lean Mass
Description
Measured by Dual X-Ray Densitometry
Time Frame
8 Months
Title
Physical Activity
Description
Measured by Actigraphy
Time Frame
8 Months
Title
Biomarkers
Description
IGF-1
Time Frame
8 Months
Title
Gene Expression
Description
Circulating leukocyte gene expression associated with exercise
Time Frame
8 Months
Title
Gas Exchange Variables
Description
V̇O2
Time Frame
8 Months
Title
Gas Exchange Variables
Description
Carbon dioxide output
Time Frame
8 Months
Title
Gas Exchange Variables
Description
V̇CO2
Time Frame
8 Months
Title
Gas Exchange Variables
Description
ventilation
Time Frame
8 Months
Title
Gas Exchange Variables
Description
V̇E
Time Frame
8 Months
Title
Gas Exchange Variables
Description
heart rate (HR)
Time Frame
8 Months
Title
Fat Mass
Description
Measured by Dual Energy X-Ray Absorptiometry
Time Frame
8 Months
Title
% Body Fat
Description
Measured by Dual X-Ray Densitometry
Time Frame
8 Months
Title
Whole Body Bone Mineral Content
Description
Measured by Dual X-Ray Densitometry
Time Frame
8 Months
Title
Whole Body Bone Mineral Density
Description
Measured by Dual X-Ray Densitometry
Time Frame
8 Months
Title
Biomarkers
Description
IL6
Time Frame
8 Months
Title
Biomarkers
Description
C-Reactive Protein
Time Frame
8 Months
Title
Biomarkers
Description
Glucose
Time Frame
8 Months
Title
Biomarkers
Description
insulin
Time Frame
8 Months
Title
Biomarkers
Description
lipid screen
Time Frame
8 Months
Title
Biomarkers
Description
lactate
Time Frame
8 Months
Title
Biomarkers
Description
CBC
Time Frame
8 Months
Title
Gene Expression
Description
Circulating Leukocyte Gene Expression Associated with Sickle Cell Anemia
Time Frame
8 Months
Title
Gene Expression
Description
Circulating Leukocyte Gene Expression Associated with Cystic Fibrosis
Time Frame
8 Months
Secondary Outcome Measure Information:
Title
Behavioral responses to exercise
Description
PROMIS Parent Fatigue Questionnaire
Time Frame
8 Months
Title
Standardized assessments
Description
TANNER Staging Questionnaire
Time Frame
8 Months
Title
Behavioral responses to exercise
Description
PROMIS Pediatric Fatigue Questionnaire
Time Frame
8 Months
Title
Behavioral responses to exercise
Description
Project REACH NHANES PAQ Adapted Questionnaire
Time Frame
8 Months
Title
Behavioral responses to exercise
Description
PEDSQL Fatigue Questionnaire
Time Frame
8 Months
Title
Behavioral responses to exercise
Description
Appendices Questionnaire
Time Frame
8 Months
Title
Standardized assessments
Description
Block Standardized FFQ
Time Frame
8 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Horvath, Ph.D.
Phone
(714) 456-8248
Email
phorvath@hs.uci.edu
Facility Information:
Facility Name
University of California, Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shlomit Radom-Aizik, Ph.D.
Phone
949-824-2584
Email
saizik@hs.uci.edu
First Name & Middle Initial & Last Name & Degree
Dan Cooper, M.D.
Phone
(949) 824-1923
Email
dcooper@hs.uci.edu

12. IPD Sharing Statement

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Exercise in Child Health

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