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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00685-42 | Other Identifier | ID-RCB number, ANSM |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| multiple examinations | Device | biological,clinical, X-ray, DXA, accelerometry assessment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dual energy-ray absorptiometry (bone mineral density) | 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 | At 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Dual energy-ray absorptiometry (Fat Mass) | 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 |
| Dual energy-ray absorptiometry (Fat Free Mass) |
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Inclusion Criteria:
Exclusion Criteria:
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Children and Adolescents With Inflammatory Bowel Disease: Crohn´s disease and Ulcerative colitis
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| Name | Affiliation | Role |
|---|---|---|
| Dominique TURCK, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Investigation Center | Lille | Nord | 59037 | France | ||
| Chu Amiens-Picardie - Site Sud |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36735394 | Result | Vanhelst J, Beghin L, Drumez E, Djeddi-Dine D, Tuck D, Coopman S, Gottrand F, Ley D. Validation of the IMPACT-III Questionnaire in French Children With Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2023 Apr 1;76(4):e71-e76. doi: 10.1097/MPG.0000000000003716. Epub 2023 Feb 2. |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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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
| At 3 weeks |
| Accelerometry ( Physical Activity) | We assess the Physical Activity with the accelerometry method during 7 consecutive days | At 3 weeks |
| IMPACT III Questionnaire (quality of life) | 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 |
| PedsQL Questionnaire (quality of life) | We assess the quality of life throughout the PedsQL questionnaire at the visit 2 corresponding at 3 weeks after the visit 1 | At 3 weeks |
| Amiens |
| France |
| Centre Hospitalier | Arras | France |
| Centre hospitalier | Béthune | France |
| Centre Hospitalier | Lens | France |
| Centre Hospitalier St Vincent | Lille | France |
| Centre Hospitalier | Roubaix | France |
| D001519 | Behavior |