Health and Exercise Response in Children With Chronic and Auto-immune Pathologies
Not applicable · Testing indirect calorimetry · 1 site · University Hospital, Clermont-Ferrand
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing indirect calorimetry to see if it can prevent disease or complications. Condition(s) listed: Juvenile Idiopathic Arthritis, Diabetes and Inflammatory Bowel Disease.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 6 to 18
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- for patients:
- Aged between 6 and 18-year-old
- Male or female
Plus 8 more requirement(s). There are also 8 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 300 participants are expected to take part.
- Start date: 2019-05-02.
- Main results expected around 2028-12-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in France.
Main thing being measured
- Maximal lipid oxidation rate during submaximal incremental exercise (at first test (at day 1))
In the researchers’ words
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 is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Juvenile Idiopathic Arthritis; Diabetes; Inflammatory Bowel Disease; Cancer Survivor; Anorexia Nervosa |
| Lead sponsor | University Hospital, Clermont-Ferrand |
| Collaborators | Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques; INSERM CIC 1405 |
| Enrollment | 300 (estimated) |
| Start date | 2019-05-02 |
| Primary completion (est.) | 2028-12-31 |
| First posted | 2019-04-12 |
| Last updated | 2019-05-08 |
| Official title | Evaluation of Chronic Pathologies Impact and Their Treatments on Children and Teen Physical Fitness. |
| ClinicalTrials.gov ID | NCT03913962 |
Interventions
- indirect calorimetry (Other)
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.
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Chu Clermont-Ferrand | Clermont-Ferrand | France | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.