Health and Exercise Response in Children With Chronic and Auto-immune Pathologies
HERCCULE
Evaluation of Chronic Pathologies Impact and Their Treatments on Children and Teen Physical Fitness.
2 other identifiers
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2019
CompletedFirst Posted
Study publicly available on registry
April 12, 2019
CompletedStudy Start
First participant enrolled
May 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
May 8, 2019
May 1, 2019
9.7 years
April 4, 2019
May 6, 2019
Conditions
Keywords
Outcome Measures
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
at first test (at day 1)
Secondary Outcomes (12)
Maximal strength during isometric contraction
at day 1
Muscle architecture
At 6 months
Body composition
At 6 months
Maximal muscular strength
At day 1
Muscular fatigue
at 6 months
- +7 more secondary outcomes
Study Arms (2)
Patient
EXPERIMENTALPatients with juvenile idiopathic arthritis, type 1 diabete mellitus, inflammatory bowel diseases, anorexia nervosa, cancer survivor
Control
ACTIVE COMPARATORhealthy children sex- and age-matched
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu Clermont-Ferrand
Clermont-Ferrand, 63003, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Etienne MERLIN
University Hospital, Clermont-Ferrand
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- no masking
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2019
First Posted
April 12, 2019
Study Start
May 2, 2019
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
May 8, 2019
Record last verified: 2019-05