Cystic FibrosisProject REACHNCT05359991
Exercise in Child Health
A study testing Exercise in people with Cystic Fibrosis and Sickle Cell Disease, run by University of California, Irvine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis, Sickle Cell Disease, SARS CoV 2 Infection
- What is being tested?
- Exercise
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2020to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, Irvine
Irvine, California, 92697
Shlomit Radom-Aizik, Ph.D., (949) 824-2584, saizik@hs.uci.edu
Dan Cooper, M.D., (949) 824-1923, dcooper@hs.uci.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Cystic Fibrosis, Sickle Cell Disease, SARS CoV 2 Infection
- Being tested
- Exercise
- Medical subject headings
- Cystic Fibrosis, Anemia, Sickle Cell, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Active comparator | 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. Receives: Other: Exercise |
| Children With Documented History of SARS CoV-2 Infection | Experimental | 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. Receives: Other: Exercise |
| Children With Sickle Cell Disease (SCD) | Experimental | 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. Receives: Other: Exercise |
| Children With Cystic Fibrosis (CF) | Experimental | 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. Receives: Other: Exercise |
| Children with Hyperlipidemia | Experimental | 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. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gas Exchange Variables
oxygen uptake
Measured: 8 Months
Whole Body Lean Mass
Measured by Dual X-Ray Densitometry
Measured: 8 Months
Physical Activity
Measured by Actigraphy
Measured: 8 Months
Biomarkers
IGF-1
Measured: 8 Months
Gene Expression
Circulating leukocyte gene expression associated with exercise
Measured: 8 Months
Gas Exchange Variables
V̇O2
Measured: 8 Months
Gas Exchange Variables
Carbon dioxide output
Measured: 8 Months
Gas Exchange Variables
V̇CO2
Measured: 8 Months
Gas Exchange Variables
ventilation
Measured: 8 Months
Gas Exchange Variables
V̇E
Measured: 8 Months
Gas Exchange Variables
heart rate (HR)
Measured: 8 Months
Fat Mass
Measured by Dual Energy X-Ray Absorptiometry
Measured: 8 Months
% Body Fat
Measured by Dual X-Ray Densitometry
Measured: 8 Months
Whole Body Bone Mineral Content
Measured by Dual X-Ray Densitometry
Measured: 8 Months
Whole Body Bone Mineral Density
Measured by Dual X-Ray Densitometry
Measured: 8 Months
Biomarkers
IL6
Measured: 8 Months
Biomarkers
C-Reactive Protein
Measured: 8 Months
Biomarkers
Glucose
Measured: 8 Months
Biomarkers
insulin
Measured: 8 Months
Biomarkers
lipid screen
Measured: 8 Months
Biomarkers
lactate
Measured: 8 Months
Biomarkers
CBC
Measured: 8 Months
Gene Expression
Circulating Leukocyte Gene Expression Associated with Sickle Cell Anemia
Measured: 8 Months
Gene Expression
Circulating Leukocyte Gene Expression Associated with Cystic Fibrosis
Measured: 8 Months
Secondary outcomes (7)
Behavioral responses to exercise
PROMIS Parent Fatigue Questionnaire
Measured: 8 Months
Standardized assessments
TANNER Staging Questionnaire
Measured: 8 Months
Behavioral responses to exercise
PROMIS Pediatric Fatigue Questionnaire
Measured: 8 Months
Behavioral responses to exercise
Project REACH NHANES PAQ Adapted Questionnaire
Measured: 8 Months
Behavioral responses to exercise
PEDSQL Fatigue Questionnaire
Measured: 8 Months
Behavioral responses to exercise
Appendices Questionnaire
Measured: 8 Months
Standardized assessments
Block Standardized FFQ
Measured: 8 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start12 Nov 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Orange County, Children's Hospital Los Angeles, Ann & Robert H Lurie Children's Hospital of Chicago
- Responsible party
- Principal investigator, Dan Cooper, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359991
- Sponsor's protocol ID
- STUDY00000028 (20195402)
- Acronym
- Project REACH
- Status last verified
- Jan 2026
- First submitted
- 31 Mar 2022
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Klentrou P. Influence of Exercise and Training on Critical Stages of Bone Growth and Development. Pediatr Exerc Sci. 2016 May;28(2):178-86. doi: 10.1123/pes.2015-0265. Epub 2016 Feb 17.
PubMed 26884506Shay CM, Ning H, Daniels SR, Rooks CR, Gidding SS, Lloyd-Jones DM. Status of cardiovascular health in US adolescents: prevalence estimates from the National Health and Nutrition Examination Surveys (NHANES) 2005-2010. Circulation. 2013 Apr 2;127(13):1369-76. doi: 10.1161/CIRCULATIONAHA.113.001559. Epub 2013 Apr 1.
PubMed 23547177Gates PE, Strain WD, Shore AC. Human endothelial function and microvascular ageing. Exp Physiol. 2009 Mar;94(3):311-6. doi: 10.1113/expphysiol.2008.043349. Epub 2008 Nov 28.
PubMed 19042980Mielgo-Ayuso J, Aparicio-Ugarriza R, Castillo A, Ruiz E, Avila JM, Aranceta-Batrina J, Gil A, Ortega RM, Serra-Majem L, Varela-Moreiras G, Gonzalez-Gross M. Physical Activity Patterns of the Spanish Population Are Mostly Determined by Sex and Age: Findings in the ANIBES Study. PLoS One. 2016 Feb 25;11(2):e0149969. doi: 10.1371/journal.pone.0149969. eCollection 2016.
PubMed 26914609Herman KM, Hopman WM, Sabiston CM. Physical activity, screen time and self-rated health and mental health in Canadian adolescents. Prev Med. 2015 Apr;73:112-6. doi: 10.1016/j.ypmed.2015.01.030. Epub 2015 Feb 4.
PubMed 25660484Maher CA, Toohey M, Ferguson M. Physical activity predicts quality of life and happiness in children and adolescents with cerebral palsy. Disabil Rehabil. 2016;38(9):865-9. doi: 10.3109/09638288.2015.1066450. Epub 2015 Jul 28.
PubMed 26218617Mutlu EK, Mutlu C, Taskiran H, Ozgen IT. Association of physical activity level with depression, anxiety, and quality of life in children with type 1 diabetes mellitus. J Pediatr Endocrinol Metab. 2015 Nov 1;28(11-12):1273-8. doi: 10.1515/jpem-2015-0082.
PubMed 26197465Pacheco DR, Silva MJ, Alexandrino AM, Torres RM. Exercise-related quality of life in subjects with asthma: a systematic review. J Asthma. 2012 Jun;49(5):487-95. doi: 10.3109/02770903.2012.680636. Epub 2012 May 3.
PubMed 22554022Kohl HW 3rd, Craig CL, Lambert EV, Inoue S, Alkandari JR, Leetongin G, Kahlmeier S; Lancet Physical Activity Series Working Group. The pandemic of physical inactivity: global action for public health. Lancet. 2012 Jul 21;380(9838):294-305. doi: 10.1016/S0140-6736(12)60898-8.
PubMed 22818941Nishi A, Milner DA Jr, Giovannucci EL, Nishihara R, Tan AS, Kawachi I, Ogino S. Integration of molecular pathology, epidemiology and social science for global precision medicine. Expert Rev Mol Diagn. 2016;16(1):11-23. doi: 10.1586/14737159.2016.1115346. Epub 2015 Dec 4.
PubMed 26636627Briggs AM, Cross MJ, Hoy DG, Sanchez-Riera L, Blyth FM, Woolf AD, March L. Musculoskeletal Health Conditions Represent a Global Threat to Healthy Aging: A Report for the 2015 World Health Organization World Report on Ageing and Health. Gerontologist. 2016 Apr;56 Suppl 2:S243-55. doi: 10.1093/geront/gnw002.
PubMed 26994264Chu P, Pandya A, Salomon JA, Goldie SJ, Hunink MG. Comparative Effectiveness of Personalized Lifestyle Management Strategies for Cardiovascular Disease Risk Reduction. J Am Heart Assoc. 2016 Mar 29;5(3):e002737. doi: 10.1161/JAHA.115.002737.
PubMed 27025969Jimenez-Pavon D, Kelly J, Reilly JJ. Associations between objectively measured habitual physical activity and adiposity in children and adolescents: Systematic review. Int J Pediatr Obes. 2010;5(1):3-18. doi: 10.3109/17477160903067601.
PubMed 19562608Tirakitsoontorn P, Nussbaum E, Moser C, Hill M, Cooper DM. Fitness, acute exercise, and anabolic and catabolic mediators in cystic fibrosis. Am J Respir Crit Care Med. 2001 Oct 15;164(8 Pt 1):1432-7. doi: 10.1164/ajrccm.164.8.2102045.
PubMed 11704591Alvarado AM, Ward KM, Muntz DS, Thompson AA, Rodeghier M, Fernhall B, Liem RI. Heart rate recovery is impaired after maximal exercise testing in children with sickle cell anemia. J Pediatr. 2015 Feb;166(2):389-93.e1. doi: 10.1016/j.jpeds.2014.10.064. Epub 2014 Dec 2.
PubMed 25477159