University of California, Irvine
Irvine, California, 92697, United States
Location status: Recruiting
Location contact
Dan Cooper, M.D.
CONTACT
Shlomit Radom-Aizik, Ph.D.
CONTACT
NCT Number: NCT05359991
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.
Interested in participating?
Request Info10 year–17 year
All sexes
Interventional
Not applicable
Irvine, California, 92697, United States
Location status: Recruiting
Dan Cooper, M.D.
CONTACT
Shlomit Radom-Aizik, Ph.D.
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Sickle Cell Disease
Cystic Fibrosis
Comparison (Healthy control)
Comparison (SARS-CoV-2)
Exclusion criteria
Sickle Cell Disease Treatment for substance or alcohol abuse
Cystic Fibrosis Treatment for substance or alcohol abuse
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
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
Time frame: 8 Months
oxygen uptake
Time frame: 8 Months
Measured by Dual X-Ray Densitometry
Time frame: 8 Months
Measured by Actigraphy
Time frame: 8 Months
IGF-1
Time frame: 8 Months
Circulating leukocyte gene expression associated with exercise
Time frame: 8 Months
V̇O2
Time frame: 8 Months
Carbon dioxide output
Time frame: 8 Months
V̇CO2
Time frame: 8 Months
ventilation
Time frame: 8 Months
V̇E
Time frame: 8 Months
heart rate (HR)
Time frame: 8 Months
Measured by Dual Energy X-Ray Absorptiometry
Time frame: 8 Months
Measured by Dual X-Ray Densitometry
Time frame: 8 Months
Measured by Dual X-Ray Densitometry
Time frame: 8 Months
Measured by Dual X-Ray Densitometry
Time frame: 8 Months
IL6
Time frame: 8 Months
C-Reactive Protein
Time frame: 8 Months
Glucose
Time frame: 8 Months
insulin
Time frame: 8 Months
lipid screen
Time frame: 8 Months
lactate
Time frame: 8 Months
CBC
Time frame: 8 Months
Circulating Leukocyte Gene Expression Associated with Sickle Cell Anemia
Time frame: 8 Months
Circulating Leukocyte Gene Expression Associated with Cystic Fibrosis
Time frame: 8 Months
PROMIS Parent Fatigue Questionnaire
Time frame: 8 Months
TANNER Staging Questionnaire
Time frame: 8 Months
PROMIS Pediatric Fatigue Questionnaire
Time frame: 8 Months
Project REACH NHANES PAQ Adapted Questionnaire
Time frame: 8 Months
PEDSQL Fatigue Questionnaire
Time frame: 8 Months
Appendices Questionnaire
Time frame: 8 Months
Block Standardized FFQ
Contact information is provided by the study sponsor or research team.
University of California, Irvine
Other
Revamping Exercise Assessments in Child Health (Project REACH)
Acronym: Project REACH
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06147414
Abnormalities, Multiple, Anemia
Paris, France
View Trial DetailsNCT06539169
Alpha-Thalassemia, Alzheimer Disease
Los Altos, California, United States
View Trial DetailsNCT03938324
Anemia, Anemia, Hemolytic
Durham, North Carolina, United States
View Trial DetailsNCT03655223
17 Alpha-Hydroxylase Deficiency, 3-Hydroxy-3-Methylglutaric Aciduria
Research Triangle Park, North Carolina, United States
View Trial Details