Sarcopenia and Juvenile Idiopathic Arthritis (SAJI)
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ambre HITTINGER-ROUX
- 電話番号：0033 03 10 73 67 07
- メール：ahittinger-roux@chu-reims.fr
研究連絡先のバックアップ
- 名前：Jean-Hugues SALMON
- 電話番号：0033 03 26 78 44 21
- メール：jhsalmon@chu-reims.fr
研究場所
-
-
-
Reims、フランス
- Marie Muller
-
コンタクト：
- Ambre HITTINGER-ROUX
- 電話番号：0033 03 10 73 67 07
- メール：ahittinger-roux@chu-reims.fr
-
コンタクト：
- Jean-Hugues SALMON
- 電話番号：0033 03 26 78 44 21
- メール：jhsalmon@chu-reims.fr
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ふるい分け
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：Patients with juvenile idiopathic arthritis
Single group of adolescents and adults with juvenile idiopathic arthritis undergoing a standardized sarcopenia screening assessment at inclusion.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sarcopenia
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Fatigue assessed by FACIT-F
時間枠：Day 1
|
Fatigue assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire
|
Day 1
|
|
Physical activity assessed by IPAQ
時間枠：Day 1
|
Physical activity assessed using the International Physical Activity Questionnaire (IPAQ)
|
Day 1
|
|
Functional disability assessed by HAQ-DI
時間枠：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
時間枠：Day 1
|
Health-related quality of life assessed using the 12-Item Short Form Health Survey (SF-12).
|
Day 1
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。