Health and Exercise Response in Children With Chronic and Auto-immune Pathologies

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-18
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

The aim of the present project is to assess the effects of the chronic diseases and their associated treatments chronic paediatric diseases (CPD), to further understand their impact on physical fitness for public health perspectives. This is an innovative approach in the treatment of chronic paediatric diseases . This project should yield results that help improving treatments for children and adolescents with chronic paediatric diseases throughout physical activity as therapy, reduced pain, fatigue and inflammation, and improvement in physical fitness and life quality. The originality and novelty of this project is to combine architectural, functional and metabolic components of skeletal muscle to further understand the impact of chronic paediatric diseases as a function of treatment, disease activity and maturation status (prepubertal, pubertal or post pubertal).

This study will aim at assessing muscular function (force production capacity and fatigability) in specific or ecologic situations so as to get information about muscle functioning on isolated muscle group (here knee extensors) or during whole body exercise. Moreover, results arising from muscle architecture or quality will allow understanding the decrease in strength or endurance reported in the literature. The data collected will allow us to further understand the impact of the disease on structural, functional and metabolic parameters. Finally, the understanding of these alterations will provide information enabling to establish recommendations in physical activity (PA) to reduce or even counter the effect of the chronic inflammation and prevent at long-term overweight and cardiovascular risks.

The long-term objective is to contribute establishing recommendations or guidelines for prescribing physical activity during medical therapy. Values obtained in pathological children will be compared to those of control children matched for gender and maturation.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged between 6 and 18-year-old

Male or female

Presenting a chronic pathology / having a treatment which is known to alter muscle mass and function, metabolism and body composition

Included in the active list of the hospital centre of Clermont-Ferrand

Disqualifiers

Treatment by systemic corticoids (>1 week in the 30 days before test)

Contraindication to sport practice

Contraindication to sport practice

Chronic pathology susceptible to alter muscle mass and function, metabolism and body composition

Trial design

Design model

Single group

Treatments tested in this trial

  • indirect calorimetry

    Other intervention

    Patients will be separated in different subgroups. Subgroups will be constituted according the disease status (i.e. active vs inactive) to assess the impact of the pathology on physical fitness and according to treatments to assess the effect of treatment on physical fitness.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: PatientExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Maximal lipid oxidation rate during submaximal incremental exercise

Percentage variation of the maximal strength rate during isometric contraction between pathological and healthy children

Time frame
at first test (at day 1)

Secondary outcomes

1

Maximal strength during isometric contraction

Percentage variation of the maximal strength rate during isometric contraction between pathological and healthy children

Time frame
at day 1
2

Muscle architecture

muscle cross sectional area (mm2) evaluated by peripheral Quantitative Computed Tomography (pQCT)

Time frame
At 6 months
3

Body composition

fat mass (g.cm²) evaluated by Dual-energy X-ray absorptiometry

Time frame
At 6 months
4

Maximal muscular strength

maximal strength of knee extensors

Time frame
At day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Clermont-Ferrand

Lead sponsor

Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques

Collaborator

INSERM CIC 1405

Collaborator