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HealthySAIN&NORMESNCT04876209

Reference Values of Aerobic Fitness in the Contemporary Paediatric Population

An observational study of Healthy and Obese, run by University Hospital, Montpellier at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 6 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Obese
How many people
950 participants
Where
1 siteFrance
Study dates
1 Nov 2019to 1 May 2021
Phase
Observational
Are there results?
None posted in the registry

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 6 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: 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.

Who may be able to join

  • Child from 6 to 17 years old having performed a cardio-respiratory exercise test for chest pain, dyspnea on exertion, heart murmur and whose results do not find:
  • congenital heart disease (normal echocardiography and ECG)
  • respiratory disease (normal FEV1 and FVC)
  • Child having performed a maximal cardio-respiratory stress exercise until exhaustion.
  • Child with BMI>85e percentile
  • Child from 6 to 17 years old having performed a cardio-respiratory exercise test for checkup and whose results do not find:
  • congenital heart disease (normal echocardiography and ECG)
  • Child having performed a maximal cardio-respiratory stress exercise until exhaustion.

Who cannot join

  • Child taking long-term drug treatment
  • Child with chronic disease
  • Parents' refusal to use medical data.
  • Obese children:
  • Child taking long-term drug treatment (except for their metabolic syndrome)
  • Child with chronic disease (except their metabolic syndrome)
  • Parents' refusal to use medical data.
  • Part 2 : Validation of Z-score equations from an independent population The same criteria will be used for the patients of the Munich center and the Boston center to test our equations

Trial locations and contacts

1 site in 1 country.

France1 site
  • Uh Montpellier

    Montpellier, 34295

Other trials in France

About this study

Official title: Reference Values of Aerobic Fitness in the Contemporary Paediatric Population: VO2max Z-scores

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.).

Read more

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).

Read the detailed description

This cross-sectional study included healthy children from 6 to 17 years old and obese children with no other comorbidities other than those due to metabolic syndrome (hypertension, dyslipidemia, type 2 diabetes sleep apnea, hepatic steatosis). Patients refuse the use of medical data will be excluded.

Part 1 - Z-score equations: After description of the study sample, the regression method will be identified (linear, polynomial, logarithmic, spline, etc.). The main anthropometric determinants (age, gender, height, weight, BMI) will be tested, and the mathematical models that best fit to the data will be identified (use of the adjusted coefficient of determination R2). The models will calculate, for each subject, the difference between the value predicted by the model and the value actually observed (residuals of the model). The occurrence of heteroscedasticity (e.g. the circumstance in which the variability of a variable is unequal across the range of values of a second variable that predicts it) will be tested. The Z-scores will be measured by the difference between predicted values and observed values divided by the calculated standard deviation.

Part 2- Validation of Z-score equations from an independent population The validity of the Z-score equations will be tested on a cohort of 100 pediatric in 6 to 18 year-old children, from pediatric CPET laboratories that did not participate in the part 1 study. The CPET variables may be retrospectively collected from existing database or prospectively collected, but no CPET should be performed for the only purpose of the research (observational study)

Conditions
Healthy, Obese
Keywords
Cardiopulmonary exercise test, Z score, Pediatric, VO2max, VE/VCO2 slope
Medical subject headings
Obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: day 1

  2. 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)

    Measured: day 1

Secondary outcomes (17)
  1. validity of the VO2max Z-score equations

    validity of the VO2max Z-score equations will be tested from cohort from pediatric CPET laboratories that did not participate in the part 1 study. To analyze this, we will compare the difference between the measured VO2max and the VO2max predicted by the Wassermann equation (Wassermann's predicted value - observed value) and the difference between the measured VO2max and the VO2max predicted by our equation (Gavotto's predicted value - observed value)

    Measured: day 1

  2. identify the parameters of an equation for calculating ventilatory anaerobic threshold Z-scores

    identify the parameters of an equation for calculating ventilatory anaerobic threshold Z-scores (potentially using age, sex, height, weight or skin surface area)

    Measured: 1 day

  3. estimate the parameters of an equation for calculating ventilatory anaerobic threshold Z-scores

    estimate the parameters of an equation for calculating ventilatory anaerobic threshold Z-scores (potentially using age, sex, height, weight or skin surface area)

    Measured: 1 day

  4. identify the parameters of an equation for calculating VE/VCO2 slope Z-scores

    identify the parameters of an equation for calculating VE/VCO2 slope Z-scores (potentially using age, sex, height, weight or skin surface area)

    Measured: 1 day

  5. estimate the parameters of an equation for calculating VE/VCO2 slope Z-scores

    estimate the parameters of an equation for calculating VE/VCO2 slope Z-scores (potentially using age, sex, height, weight or skin surface area)

    Measured: 1 day

  6. identify the parameters of an equation for calculating oxygen uptake efficiency slope Z-scores

    identify the parameters of an equation for calculating oxygen uptake efficiency slope Z-scores (potentially using age, sex, height, weight or skin surface area)

    Measured: 1 day

  7. estimate the parameters of an equation for calculating oxygen uptake efficiency slope Z-scores

    estimate the parameters of an equation for calculating oxygen uptake efficiency slope Z-scores (potentially using age, sex, height, weight or skin surface area)

    Measured: 1 day

  8. identify the parameters of an equation for calculating oxygen pulse Z-scores

    identify the parameters of an equation for calculating oxygen pulse Z-scores (potentially using age, sex, height, weight or skin surface area)

    Measured: 1 day

  9. estimate the parameters of an equation for calculating oxygen pulse Z-scores

    estimate the parameters of an equation for calculating oxygen pulse Z-scores (potentially using age, sex, height, weight or skin surface area)

    Measured: 1 day

  10. identify the parameters of an equation for calculating maximal respiratory frequency Z-scores

    identify the parameters of an equation for calculating maximal respiratory frequency Z-scores (potentially using age, sex, height, weight or skin surface area)

    Measured: 1 day

  11. stimate the parameters of an equation for calculating maximal respiratory frequency Z-scores

    estimate the parameters of an equation for calculating maximal respiratory frequency Z-scores (potentially using age, sex, height, weight or skin surface area)

    Measured: 1 day

  12. identify the parameters of an equation for calculating maximal maximal tidal volume Z-scores

    identify the parameters of an equation for calculating maximal maximal tidal volume Z-scores (potentially using age, sex, height, weight or skin surface area)

    Measured: 1 day

  13. estimate the parameters of an equation for calculating maximal maximal tidal volume Z-scores

    estimate the parameters of an equation for calculating maximal maximal tidal volume Z-scores (potentially using age, sex, height, weight or skin surface area)

    Measured: 1 day

  14. identify the parameters of an equation for calculating breath reserve Z-scores

    identify the parameters of an equation for calculating breath reserve Z-scores (potentially using age, sex, height, weight or skin surface area)

    Measured: 1 day

  15. estimate the parameters of an equation for calculating breath reserve Z-scores

    estimate the parameters of an equation for calculating breath reserve Z-scores (potentially using age, sex, height, weight or skin surface area)

    Measured: 1 day

  16. estimate the parameters of an equation for calculating maximal pet end tidal CO2 Z-scores

    estimate the parameters of an equation for calculating maximal pet end tidal CO2 Z-scores (potentially using age, sex, height, weight or skin surface area)

    Measured: 1 day

  17. identify the parameters of an equation for calculating maximal pet end tidal CO2 Z-scores

    identify the parameters of an equation for calculating maximal pet end tidal CO2 Z-scores (potentially using age, sex, height, weight or skin surface area)

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2021
  2. Study start1 Nov 2019
  3. Primary completion1 Jan 2021
  4. Study completion1 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
950 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04876209
Sponsor's protocol ID
RECHMPL19_0475
Acronym
SAIN&NORMES
Status last verified
Oct 2023
First submitted
2 May 2021
Last updated
27 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: NC

Publications

  • 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.

    PubMed 37528295
  • 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.

    PubMed 36809338
  • 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.

    PubMed 41785991

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy and Obese, run by University Hospital, Montpellier at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

identify the parameters of an equation for calculating VO2max Z-scores (time frame: day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04876209, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.

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