Physical Activity and Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease (PHYSICOSMICI)
11. maj 2026 opdateret af: University Hospital, Lille
Relationship Between Physical Activity and Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease
This study is an observational study.
The purpose of this study is to assess the relationship between bone health and daily physical activity in children and adolescents with inflammatory bowel disease (IBD).
Reduced bone mineral density is a common complication in pediatric IBD.
Physical activity is an important determinant of health throughout the whole lifespan.
Engaging in regular moderate-to-vigorous physical activity has important health benefits.
Based on available evidence, the investigators hypothesize that daily moderate-to-vigorous physical activity could improve bone health (ie bone mineral density) in children and adolescents with IBD.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
To carry out this study, 120 patients (age ≥6 and <18 years at the screening visit) will be enrolled in this observational study.
After obtaining the informed consent from the parents and the patient, the followings will be performed: clinical examination by a physician, dual-energy X-ray absorptiometry to assess bone density mineral and body composition, collection of a blood sample to assess the inflammatory status of the IBD patient.
The patient will be asked also to fill in a questionnaire in order to assess quality of life.
He will wear an accelerometer during 7 consecutive days for assessing daily physical activity in free living conditions.
The main objective is to assess the relationship between daily physical activity and bone health in children and adolescents with IBD.
The secondary objectives are to assess the relationship between daily physical activity and: 1) body composition and 2): quality of life in IBD children and adolescents.
To our knowledge, this study is the first to assess the relationship between bone health and daily physical activity in IBD children and adolescents.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
84
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Amiens, Frankrig
- CHU Amiens-Picardie - Site Sud
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Arras, Frankrig
- Centre Hospitalier
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Béthune, Frankrig
- Centre Hospitalier
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Lens, Frankrig
- Centre Hospitalier
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Lille, Frankrig
- Centre Hospitalier St Vincent
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Roubaix, Frankrig
- Centre Hospitalier
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Nord
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Lille, Nord, Frankrig, 59037
- Clinical Investigation Center
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
6 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Children and Adolescents With Inflammatory Bowel Disease: Crohn´s disease and Ulcerative colitis
Beskrivelse
Inclusion Criteria:
- Boys or girls aged between 6 and 18 years old
- Chronic, acute or intermittent diseas (other than IBD) that can lead to decreased physical activity (example: fracture, paralysis, blindness ...
- Patient with IBD diagnosed since at least 6 months
- Written informed consent obtained by the the parents and the patient
- To have a health insurance
Exclusion Criteria:
- Acute intercurrent events (less than 15 days) at the inclusion day leading to decreased physical activity according to the investigator judgment (fracture(s), recent arthritis, perineal lesions, severe skin lesions)
- Patient refusing to participate to the study
- One of the child's parents refusing to participate to the study
- Lack of adherence foreseeable
- Participation to another study
- Pregnant girls
- Under a justice protect measure
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Patients
follow up of patients (children and adolescent) with inflammatory bowel disease in looking for the relationship between the bone mineral density and physical activity.
|
biological,clinical, X-ray, DXA, accelerometry assessment
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Dual energy-ray absorptiometry (bone mineral density)
Tidsramme: At 3 weeks
|
We assess the bone mineral density with the Dual energy-ray absorptiometry method at the visit 2 corresponding at 3 weeks after the visit 1
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At 3 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dual energy-ray absorptiometry (Fat Mass)
Tidsramme: At 3 weeks
|
We assess the Fat Mass with the Dual energy-ray absorptiometry method at the visit 2 corresponding at 3 weeks after the visit 1
|
At 3 weeks
|
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Dual energy-ray absorptiometry (Fat Free Mass)
Tidsramme: At 3 weeks
|
We assess the Fat Free Mass with the Dual energy-ray absorptiometry method at the visit 2 corresponding at 3 weeks after the visit 1
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At 3 weeks
|
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Accelerometry ( Physical Activity)
Tidsramme: At 3 weeks
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We assess the Physical Activity with the accelerometry method during 7 consecutive days
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At 3 weeks
|
|
IMPACT III Questionnaire (quality of life)
Tidsramme: At 3 weeks
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We assess the quality of life throughout the IMPACT III questionnaire at the visit 2 corresponding at 3 weeks after the visit 1
|
At 3 weeks
|
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PedsQL Questionnaire (quality of life)
Tidsramme: At 3 weeks
|
We assess the quality of life throughout the PedsQL questionnaire at the visit 2 corresponding at 3 weeks after the visit 1
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At 3 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Dominique TURCK, MD, PhD, University Hospital, Lille
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. oktober 2014
Primær færdiggørelse (Faktiske)
1. december 2017
Studieafslutning (Faktiske)
1. december 2017
Datoer for studieregistrering
Først indsendt
7. januar 2015
Først indsendt, der opfyldte QC-kriterier
16. januar 2015
Først opslået (Anslået)
19. januar 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. maj 2026
Sidst verificeret
1. januar 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2013_69
- 2014-A00685-42 (Anden identifikator: ID-RCB number, ANSM)
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