Study Summary
This trial is testing how well different types of exercise work for children with chronic diseases or conditions, like cystic fibrosis or sickle cell disease, that were once fatal but now remain chronic and debilitating.
Eligible Conditions
- Sickle Cell Disease
- Cystic Fibrosis
- COVID-19
Treatment Effectiveness
Effectiveness Progress
Study Objectives
9 Primary · 2 Secondary · Reporting Duration: 8 Months
8 Months
% Body Fat
Behavioral responses to exercise
Biomarkers
Fat Mass
Gas Exchange Variables
Gene Expression
Physical Activity
Standardized assessments
Whole Body Bone Mineral Content
Whole Body Bone Mineral Density
Whole Body Lean Mass
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Healthy Controls
1 of 4
Children With Documented History of SARS CoV-2 Infection
1 of 4
Children With Sickle Cell Disease (SCD)
1 of 4
Children With Cystic Fibrosis (CF)
1 of 4
Active Control
Experimental Treatment
240 Total Participants · 4 Treatment Groups
Primary Treatment: Exercise · No Placebo Group · N/A
Children With Documented History of SARS CoV-2 Infection
Other
Experimental Group · 1 Intervention: Exercise · Intervention Types: OtherChildren With Sickle Cell Disease (SCD)
Other
Experimental Group · 1 Intervention: Exercise · Intervention Types: OtherChildren With Cystic Fibrosis (CF)
Other
Experimental Group · 1 Intervention: Exercise · Intervention Types: OtherHealthy Controls
Other
ActiveComparator Group · 1 Intervention: Exercise · Intervention Types: OtherTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 8 months
Who is running the clinical trial?
University of California, IrvineLead Sponsor
504 Previous Clinical Trials
1,881,651 Total Patients Enrolled
Children's Hospital of Orange County (CHOC)UNKNOWN
Children's Hospital of Los Angeles (CHLA)UNKNOWN
Lurie Children's Hospital in ChicagoUNKNOWN
Eligibility Criteria
Age 10 - 17 · All Participants · 22 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have cystic fibrosis.
You are between the ages of 10 to 17 and have had your physical development assessed by a doctor or through a validated self-assessment tool.
Your body mass index (BMI) is within a healthy range for your age and health condition.
Participants are between 10 and 17 years old and have not reached full physical maturity.
Participants should be between 10 to 17 years old and have gone through puberty (Tanner stages 1-5).
You are a boy or girl between the ages of 10 and 17.
I'm sorry, this criterion seems incomplete or unclear. Can you please provide more context or information so I can provide a summary in plain language?
Your body mass index (BMI) and physical activity history are within the normal range for your age.
Your body weight is healthy for your age and medical condition.
References
- Briggs, Andrew M., Marita J. Cross, Damian G. Hoy, Lídia Sànchez-Riera, Fiona M. Blyth, Anthony D. Woolf, and Lyn March. 2016. “Musculoskeletal Health Conditions Represent a Global Threat to Healthy Aging: A Report for the 2015 World Health Organization World Report on Ageing and Health”. The Gerontologist. Oxford University Press (OUP). doi:10.1093/geront/gnw002.
- Liem, Robert I., Madhuri Reddy, Stephanie A. Pelligra, Adrienne P. Savant, Bo Fernhall, Mark Rodeghier, and Alexis A. Thompson. 2015. “Reduced Fitness and Abnormal Cardiopulmonary Responses to Maximal Exercise Testing in Children and Young Adults with Sickle Cell Anemia”. Physiological Reports. Wiley. doi:10.14814/phy2.12338.
- Schneiderman, J. E., D. L. Wilkes, E. G. Atenafu, T. Nguyen, G. D. Wells, N. Alarie, E. Tullis, et al.. 2013. “Longitudinal Relationship Between Physical Activity and Lung Health in Patients with Cystic Fibrosis”. European Respiratory Journal. European Respiratory Society (ERS). doi:10.1183/09031936.00055513.
- Nishi, Akihiro, Danny A Milner Jr, Edward L Giovannucci, Reiko Nishihara, Andy S Tan, Ichiro Kawachi, and Shuji Ogino. 2015. “Integration of Molecular Pathology, Epidemiology and Social Science for Global Precision Medicine”. Expert Review of Molecular Diagnostics. Informa UK Limited. doi:10.1586/14737159.2016.1115346.
- Shay, Christina M., Hongyan Ning, Stephen R. Daniels, Cherie R. Rooks, Samuel S. Gidding, and Donald M. Lloyd-Jones. 2013. “Status of Cardiovascular Health in US Adolescents”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.113.001559.
- Gates, Phillip E., W. David Strain, and Angela C. Shore. 2009. “Human Endothelial Function and Microvascular Ageing”. Experimental Physiology. Wiley. doi:10.1113/expphysiol.2008.043349.
- Klentrou, Panagiota. 2016. “Influence of Exercise and Training on Critical Stages of Bone Growth and Development”. Pediatric Exercise Science. Human Kinetics. doi:10.1123/pes.2015-0265.
- Herman, Katya M., Wilma M. Hopman, and Catherine M. Sabiston. 2015. “Physical Activity, Screen Time and Self-rated Health and Mental Health in Canadian Adolescents”. Preventive Medicine. Elsevier BV. doi:10.1016/j.ypmed.2015.01.030.
- Mutlu, Ebru Kaya, Caner Mutlu, Hanifegul Taskiran, and Ilker Tolga Ozgen. 2015. “Association of Physical Activity Level with Depression, Anxiety, and Quality of Life in Children with Type 1 Diabetes Mellitus”. Journal of Pediatric Endocrinology and Metabolism. Walter de Gruyter GmbH. doi:10.1515/jpem-2015-0082.
- Kohl, Harold W, 3rd, Cora Lynn Craig, Estelle Victoria Lambert, Shigeru Inoue, Jasem Ramadan Alkandari, Grit Leetongin, and Sonja Kahlmeier. 2012. “The Pandemic of Physical Inactivity: Global Action for Public Health”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(12)60898-8.
- TIRAKITSOONTORN, PORNCHAI, ELIEZER NUSSBAUM, CHUANPIT MOSER, MARYANN HILL, and DAN M. COOPER. 2001. “Fitness, Acute Exercise, and Anabolic and Catabolic Mediators in Cystic Fibrosis”. American Journal of Respiratory and Critical Care Medicine. American Thoracic Society. doi:10.1164/ajrccm.164.8.2102045.
- Maher, Carol Ann, Monica Toohey, and Monika Ferguson. 2015. “Physical Activity Predicts Quality of Life and Happiness in Children and Adolescents with Cerebral Palsy”. Disability and Rehabilitation. Informa UK Limited. doi:10.3109/09638288.2015.1066450.
- Mielgo-Ayuso, Juan, Raquel Aparicio-Ugarriza, Adrián Castillo, Emma Ruiz, José Manuel Ávila, Javier Aranceta-Batrina, Ángel Gil, et al.. 2016. “Physical Activity Patterns of the Spanish Population Are Mostly Determined by Sex and Age: Findings in the ANIBES Study”. Edited by David O. Carpenter. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0149969.
- Pacheco, Diana R. R., Manuel J. B. Silva, Ana M. S. Alexandrino, and Rui M. T. Torres. 2012. “Exercise-related Quality of Life in Subjects with Asthma: A Systematic Review”. Journal of Asthma. Informa UK Limited. doi:10.3109/02770903.2012.680636.
- Chu, Paula, Ankur Pandya, Joshua A. Salomon, Sue J. Goldie, and M. G. Myriam Hunink. 2016. “Comparative Effectiveness of Personalized Lifestyle Management Strategies for Cardiovascular Disease Risk Reduction”. Journal of the American Heart Association. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/jaha.115.002737.
- Jiménez-Pavón, David, Joanna Kelly, and John J. Reilly. 2010. “Associations Between Objectively Measured Habitual Physical Activity and Adiposity in Children and Adolescents: Systematic Review”. International Journal of Pediatric Obesity. Informa UK Limited. doi:10.3109/17477160903067601.
- Alvarado, Anthony M., Kendra M. Ward, Devin S. Muntz, Alexis A. Thompson, Mark Rodeghier, Bo Fernhall, and Robert I. Liem. 2015. “Heart Rate Recovery Is Impaired After Maximal Exercise Testing in Children with Sickle Cell Anemia”. The Journal of Pediatrics. Elsevier BV. doi:10.1016/j.jpeds.2014.10.064.
- Mielgo-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.
- Kohl 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.
- 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.
- Gates 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.
- Briggs 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.
- Jimenez-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.
- Liem RI, Reddy M, Pelligra SA, Savant AP, Fernhall B, Rodeghier M, Thompson AA. Reduced fitness and abnormal cardiopulmonary responses to maximal exercise testing in children and young adults with sickle cell anemia. Physiol Rep. 2015 Apr;3(4):e12338. doi: 10.14814/phy2.12338. Erratum In: Physiol Rep. 2016 Jan;4(1). pii: e12680. doi: 10.14814/phy2.12680.
- Tirakitsoontorn 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.
- Nishi 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.
- Pacheco 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.
- Dan Cooper 2022. "Exercise in Child Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05359991.
Frequently Asked Questions
How many participants are involved with this trial's research?
"Affirmative, the clinicaltrial.gov portal indicates that this research is actively recruiting subjects. Initially posted on May 15th 2022 and modified April 28th of the same year, 240 participants are required from a single facility." - Anonymous Online Contributor
Unverified Answer
Are there any open slots for this research project?
"As of right now, this clinical trial is actively recruiting. The study was posted on May 15th 2022 and recently updated on April 28th 2022 per the information shared by clinicaltrials.gov." - Anonymous Online Contributor
Unverified Answer
What are the qualifications for participating in this research endeavor?
"This clinical trial seeks to enroll 240 young people suffering from cystic fibrosis aged 10-17. The essential criteria for admission includes: Tanner 1-5, diagnosis of SCD including related genotypes, overall health with no complications that could interfere with the study protocol, BMI in line with age and condition parameters, confirmed CF through newborn screening or two separate tests showing mutations associated with CF as well as sweat chloride concentration >60 mmol/l., self-assessment tool validation by licensed independent provider at screening , and Sickle Cell Disease (SCD)." - Anonymous Online Contributor
Unverified Answer
Does this research study accept participants of under 45 years?
"Prospective participants must be aged between 10 and 17 years old. Currently, there are 336 trials for minors and 1099 studies for individuals who are 65 or older." - Anonymous Online Contributor
Unverified Answer