NCT03913962 Health and Exercise Response in Children With Chronic and Auto-immune Pathologies
| NCT ID | NCT03913962 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Clermont-Ferrand |
| Condition | Juvenile Idiopathic Arthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2019-05-02 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2019-05-02 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Etienne MERLIN
PRINCIPAL INVESTIGATOR
University Hospital, Clermont-Ferrand
Frequently Asked Questions
Who can join the NCT03913962 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 18 Years, studying Juvenile Idiopathic Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03913962 currently recruiting?
Yes, NCT03913962 is actively recruiting participants. Contact the research team at drci@chu-clermontferrand.fr for enrollment information.
Where is the NCT03913962 trial being conducted?
This trial is being conducted at Clermont-Ferrand, France.
Who is sponsoring the NCT03913962 clinical trial?
NCT03913962 is sponsored by University Hospital, Clermont-Ferrand. The principal investigator is Etienne MERLIN at University Hospital, Clermont-Ferrand. The trial plans to enroll 300 participants.