Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Sarcopenia and Juvenile Idiopathic Arthritis (SAJI)

3. juni 2026 oppdatert av: CHU de Reims

Prevalence Study of Sarcopenia in Juvenile Idiopathic Arthritis

Juvenile idiopathic arthritis (JIA) is a rare chronic inflammatory rheumatic disease that begins during childhood and may persist into adulthood in many patients. In addition to joint pain, swelling, and long-term articular damage, chronic inflammatory diseases may also be associated with early sarcopenia, defined as a loss of muscle strength and muscle mass. While this association has been described in adult inflammatory rheumatic diseases, it has not been well studied in patients with JIA.

The aim of this study is to screen for sarcopenia in adolescents and adults with JIA in France. Sarcopenia will be assessed using validated questionnaires, hand grip strength measured with a Jamar dynamometer, and body composition measured by dual-energy X-ray absorptiometry (DEXA). Completion of validated questionnaires will assess nutritional status, fatigue, physical activity, and functional impact. Socio-demographic and clinical data will also be collected from medical records.

This multicenter cross-sectional study will be conducted between June 2026 and October 2027 in 11 French hospitals. Eligible participants are patients aged 15 to 40 years with JIA diagnosed according to ILAR criteria and followed in a French hospital.

This study will provide the first estimate of sarcopenia prevalence among patients with JIA in France. It will also help identify factors associated with sarcopenia and its impact on daily functioning and quality of life. In the longer term, the findings may help clinicians better identify patients at risk and support earlier management focused on disease control, physical activity, and nutritional care.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This is a national multicenter cross-sectional study conducted in 11 French hospitals between June 2026 and October 2027. The study aims to assess sarcopenia in adolescents and adults with juvenile idiopathic arthritis (JIA) during a routine rheumatology follow-up visit.

After receiving study information and providing informed consent (with parental/legal guardian consent for minors, according to applicable regulations), participants will undergo a standardized single study assessment during routine care. This assessment will include measurement of hand grip strength using a Jamar dynamometer, whole-body dual-energy X-ray absorptiometry (DEXA) for body composition and appendicular lean mass evaluation, and completion of validated questionnaires addressing nutritional status, fatigue, physical activity, and functional impact. Additional socio-demographic and clinical data related to JIA history, disease characteristics, and treatments will be collected from medical records.

The study is designed to estimate the prevalence of sarcopenia in patients with JIA in France and to explore factors associated with sarcopenia and its functional impact. If sarcopenia is identified, additional management may be proposed by the treating physician as part of usual care.

Studietype

Intervensjonell

Registrering (Antatt)

200

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Barn
  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

inclusion criteria :

  • Patients followed in French hospitals participating in the study for juvenile idiopathic arthritis, all forms combined, diagnosed according to the ILAR criteria defined in Edmonton in 2001
  • Patients aged 15 to 40 years
  • Affiliated to social security
  • Agreeing to participate in the study and having given their written consent (signed consent form).

In the case of a minor patient, the consent of the patient and their legal guardians is required.

exclusion criteria :

  • Patient under legal guardianship
  • Patient not covered by social security
  • Pregnant woman
  • Inability to perform a functional test required by the study (grip test or whole-body DEXA scan)
  • Inability to understand the questionnaires

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Screening
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Patients with juvenile idiopathic arthritis
Single group of adolescents and adults with juvenile idiopathic arthritis undergoing a standardized sarcopenia screening assessment at inclusion.
Annen: Sarcopenia screening assessment
Participants will undergo a standardized single-visit assessment including hand grip strength measurement, whole-body DEXA scan for body composition, validated questionnaires, and collection of socio-demographic and clinical data from medical records.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Sarcopenia
Tidsramme: Day 1

A cross-sectional assessment of sarcopenia for each included patient will be performed at a participating hospital center:

Performance of a hand grip test using a hand dynamometer (3 consecutive measurements on the dominant hand) and a whole-body DEXA scan with measurement of the appendiceal mass index Confirmation by the best grip test value < -2 SD according to the patient's age and sex on the reference curves associated with a pathological whole-body DEXA (appendiceal mass index ≤ 7 kg/m2 for men, ≤ 5.5 kg/m2 for women)
Day 1

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fatigue assessed by FACIT-F
Tidsramme: Day 1
Fatigue assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire
Day 1
Physical activity assessed by IPAQ
Tidsramme: Day 1
Physical activity assessed using the International Physical Activity Questionnaire (IPAQ)
Day 1
Functional disability assessed by HAQ-DI
Tidsramme: Day 1
Functional disability assessed using the Health Assessment Questionnaire Disability Index (HAQ-DI).
Day 1
Health-related quality of life assessed by SF-12
Tidsramme: Day 1
Health-related quality of life assessed using the 12-Item Short Form Health Survey (SF-12).
Day 1

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

CHU de Reims

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juni 2026

Primær fullføring (Antatt)

1. oktober 2027

Studiet fullført (Antatt)

1. oktober 2027

Datoer for studieregistrering

Først innsendt

3. juni 2026

Først innsendt som oppfylte QC-kriteriene

3. juni 2026

Først lagt ut (Faktiske)

8. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PL26052

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere