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SAIN&NORMES
Sponsor study identifier
observational
950
1 country
1
Study Start
November 1, 2019
Actual (reported)Primary Completion
January 1, 2021
Actual (reported)Study Completion
May 1, 2021
Actual (reported)In most pediatric medical conditions, tremendous progress in pediatrics has significantly improved the overall prognosis and transferred the mortality from childhood to adulthood. Nevertheless, chronic diseases remain the leading cause of death and physical inactivity appears to be a major aggravating factor. Yet, a good physical activity has a positive impact on quality of life and prevents future health morbidities, such as obesity and cardiovascular disease. Therefore, after focusing on the survival of children with chronic diseases, more attention is being given to health-related quality of life and secondary prevention. In this context, the cardio-pulmonary exercise test (CPET), which is a non-invasive and dynamic examination, has become the gold standard to identify subjects with impaired physical capacity and to identify the causes of their limitations (muscular, cardiac, respiratory, behavioral, etc.). Moreover, CPET is the key examination to enroll patients in personalized physical rehabilitation programs (muscle deconditioning, respiratory limitation, etc.). Despite a growing interest in CPET and individualized rehabilitation programs for chronic diseases, the investigators still face the lack of reference values for pediatric CPET. In current practice, many CPET pediatric laboratories use the reference values of maximum oxygen uptake (VO2max) defined by Cooper et al. in 1984, from a cohort of 109 healthy children. However, their equations are linear and based on weight only. Non linear equations and the use of other anthropometric variables may be relevant in pediatrics. For instance, in the current era, normal CPET pediatric values should consider the prevalence of overweight and obesity in childhood general population (respectively 30% and 10% in Europa and 35% and 25% in North America), as well as in the population of children with chronic disease. In the past decade, our group has developed a research program on physical capacity in children, with a focus on pediatric CPET and physical rehabilitation, from a cohort of nearly 1000 exercise tests in children. The lack of reliable pediatric reference values for VO2max, and all CPET variables as well, has become an important issue. In this study, the investigators aim to define pediatric reference CPET values from a large cohort of 6 to 17 year-old children, using several anthropometric variables to define the most appropriate Z-scores equations (part 1). The investigators will also validate the Z-scores equations using an independent population (part 2).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2019
Actual (reported)January 1, 2021
Actual (reported)May 1, 2021
Actual (reported)May 2, 2021
Actual (reported)May 6, 2021
Actual (reported)identify the parameters of an equation for calculating VO2max Z-scores
identify the parameters of an equation for calculating VO2max Z-scores (potentially using age, sex, height, weight or skin surface area)
day 1
estimate the parameters of an equation for calculating VO2max Z-scores
estimate the parameters of an equation for calculating VO2max Z-scores (potentially using age, sex, height, weight or skin surface area)
day 1
validity of the VO2max Z-score equations
day 1
identify the parameters of an equation for calculating ventilatory anaerobic threshold Z-scores
1 day
estimate the parameters of an equation for calculating ventilatory anaerobic threshold Z-scores
1 day
identify the parameters of an equation for calculating VE/VCO2 slope Z-scores
1 day
estimate the parameters of an equation for calculating VE/VCO2 slope Z-scores
1 day
Healthy children cohort consisted of children referred to a paediatric cardiologist for a nonsevere functional symptom related to exercise (murmur, palpitation, chest pain, and dyspnoea) or for a medical sports certificate. Obese children cohort consisted of children with BMI \> 85e percentile referred to a paediatric cardiologist for checkup.
Uh Montpellier
Montpellier, 34295, France
Amedro P, Matecki S, Pereira Dos Santos T, Guillaumont S, Rhodes J, Yin SM, Hager A, Hock J, De La Villeon G, Moreau J, Requirand A, Souilla L, Vincenti M, Picot MC, Huguet H, Mura T, Gavotto A. Reference Values of Cardiopulmonary Exercise Test Parameters in the Contemporary Paediatric Population. Sports Med Open. 2023 Aug 1;9(1):68. doi: 10.1186/s40798-023-00622-3.
Gavotto A, Mura T, Rhodes J, Yin SM, Hager A, Hock J, Guillaumont S, Vincenti M, De La Villeon G, Requirand A, Picot MC, Huguet H, Souilla L, Moreau J, Matecki S, Amedro P. Reference values of aerobic fitness in the contemporary paediatric population. Eur J Prev Cardiol. 2023 Jul 12;30(9):820-829. doi: 10.1093/eurjpc/zwad054.
Arthur GAVOTTO, MD
University Hospital, Montpellier
Pascal AMEDRO, MD, PhD
University Hospital, Montpellier
950 participants (actual enrollment reported by the registry).
First Submitted
May 2, 2021
First Posted
May 6, 2021
Study Start
November 1, 2019
Actual (reported)Contact the study team to confirm eligibility.
Peiro-Molina E, Gavotto A, Robert J, Andrianoely M, Rezola E, Manso B, Ferrer-Sargues FJ, Carrasco-Moreno JI, Matecki S, Hager A, Gauthier N, Yin SM, Guillaumont S, Mura T, Borreguero JMB, Amedro P; QUALIREHAB study group. Validation of a VO2max Z-score model for fitness assessment in a healthy Spanish pediatric population. Rev Esp Cardiol (Engl Ed). 2026 Aug;79(8):680-690. doi: 10.1016/j.rec.2026.02.006. Epub 2026 Mar 3. English, Spanish.
Primary Completion
January 1, 2021
Actual (reported)Study Completion
May 1, 2021
Actual (reported)Last Updated
October 27, 2023
Record last verified: 2023-10
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Source: ClinicalTrials.gov.
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