Diabetes Clinical Trial
— HERCCULEOfficial title:
Evaluation of Chronic Pathologies Impact and Their Treatments on Children and Teen Physical Fitness.
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 18 Years |
Eligibility |
Inclusion Criteria: - for patients: - 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 - Free and informed consent of the holders of parental authority and the patient - Affiliated with the social security system for control: - Aged between 6 and 18-year-old - Male or female - Free and informed consent of the holders of parental authority and the patient - Affiliated with the social security system Exclusion Criteria: - for patients: - Treatment by systemic corticoids (>1 week in the 30 days before test) - Contraindication to sport practice - Active infection for control: - Contraindication to sport practice - Chronic pathology susceptible to alter muscle mass and function, metabolism and body composition - Treatment susceptible to alter metabolism - Active infection |
Country | Name | City | State |
---|---|---|---|
France | Chu Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | INSERM CIC 1405, Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximal lipid oxidation rate during submaximal incremental exercise | Percentage variation of the maximal strength rate during isometric contraction between pathological and healthy children | at first test (at day 1) | |
Secondary | Maximal strength during isometric contraction | Percentage variation of the maximal strength rate during isometric contraction between pathological and healthy children | at day 1 | |
Secondary | Muscle architecture | muscle cross sectional area (mm2) evaluated by peripheral Quantitative Computed Tomography (pQCT) | At 6 months | |
Secondary | Body composition | fat mass (g.cm²) evaluated by Dual-energy X-ray absorptiometry | At 6 months | |
Secondary | Maximal muscular strength | maximal strength of knee extensors | At day 1 | |
Secondary | Muscular fatigue | Percentage variation of time to task failure duration during isometric contraction between pathological and healthy children. | at 6 months | |
Secondary | Blood sample IL-17 | blood level of inflammation markers (IL-17) | At day 1 | |
Secondary | Blood sample CRP | blood level of inflammation markers (CRP) | At day 1 | |
Secondary | Blood sample IL-6 | blood level of inflammation markers (IL-6) | At day 1 | |
Secondary | Blood sample TNF - a | blood level of inflammation markers (TNF - a) | At day 1 | |
Secondary | Blood sample IL-10 | blood level of inflammation markers (IL-10a) | At day 1 | |
Secondary | Blood sample INF | blood level of inflammation markers (INF) | At day 1 | |
Secondary | Blood sample calprotectin | blood level of inflammation markers (calprotectin) | At day 1 |
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