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

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ClinicalTrials.gov Identifier: NCT03913962
Recruitment Status : Not yet recruiting
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Collaborators:
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
INSERM CIC 1405
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.


Condition or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis Diabetes Inflammatory Bowel Disease Cancer Survivor Anorexia Nervosa Other: indirect calorimetry Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: no masking
Primary Purpose: Prevention
Official Title: Evaluation of Chronic Pathologies Impact and Their Treatments on Children and Teen Physical Fitness.
Estimated Study Start Date : May 15, 2019
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patient
Patients with juvenile idiopathic arthritis, type 1 diabete mellitus, inflammatory bowel diseases, anorexia nervosa, cancer survivor
Other: indirect calorimetry
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.

Active Comparator: Control
healthy children sex- and age-matched
Other: indirect calorimetry
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.




Primary Outcome Measures :
  1. Maximal lipid oxidation rate during submaximal incremental exercise [ Time Frame: at first test (at day 1) ]
    Percentage variation of the maximal strength rate during isometric contraction between pathological and healthy children


Secondary Outcome Measures :
  1. Maximal strength during isometric contraction [ Time Frame: at day 1 ]
    Percentage variation of the maximal strength rate during isometric contraction between pathological and healthy children

  2. Muscle architecture [ Time Frame: At 6 months ]
    muscle cross sectional area (mm2) evaluated by peripheral Quantitative Computed Tomography (pQCT)

  3. Body composition [ Time Frame: At 6 months ]
    fat mass (g.cm²) evaluated by Dual-energy X-ray absorptiometry

  4. Maximal muscular strength [ Time Frame: At day 1 ]
    maximal strength of knee extensors

  5. Muscular fatigue [ Time Frame: at 6 months ]
    Percentage variation of time to task failure duration during isometric contraction between pathological and healthy children.

  6. Blood sample IL-17 [ Time Frame: At day 1 ]
    blood level of inflammation markers (IL-17)

  7. Blood sample CRP [ Time Frame: At day 1 ]
    blood level of inflammation markers (CRP)

  8. Blood sample IL-6 [ Time Frame: At day 1 ]
    blood level of inflammation markers (IL-6)

  9. Blood sample TNF - a [ Time Frame: At day 1 ]
    blood level of inflammation markers (TNF - a)

  10. Blood sample IL-10 [ Time Frame: At day 1 ]
    blood level of inflammation markers (IL-10a)

  11. Blood sample INF [ Time Frame: At day 1 ]
    blood level of inflammation markers (INF)

  12. Blood sample calprotectin [ Time Frame: At day 1 ]
    blood level of inflammation markers (calprotectin)



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913962


Contacts
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Contact: Lise LACLAUTRE 04 73 75 49 63 drci@chu-clermontferrand.fr

Locations
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France
Chu Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Lise LACLAUTRE    04 73 75 49 63    drci@chu-clermontferrand.fr   
Principal Investigator: Etienne MERLIN         
Sub-Investigator: Justyna KANOLD         
Sub-Investigator: Daniel TERRAL         
Sub-Investigator: Stéphane ECHAUBARD         
Sub-Investigator: Nicolas KARON         
Sub-Investigator: Corinne BORDERON         
Sub-Investigator: Florentina IFSAN         
Sub-Investigator: Eric DORE         
Sub-Investigator: Isabelle PETIT         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
INSERM CIC 1405
Investigators
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Principal Investigator: Etienne MERLIN University Hospital, Clermont-Ferrand

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03913962     History of Changes
Other Study ID Numbers: CHU-409
2018-A03247-48 ( Other Identifier: 2018-A03247-48 )
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Clermont-Ferrand:
Paediatric
Auto-immunity
Treatment
Physical Activity

Additional relevant MeSH terms:
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Inflammatory Bowel Diseases
Anorexia
Anorexia Nervosa
Arthritis, Juvenile
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases