Impact of a Physical Activity Program on Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

— PROPHYSICOS  

Official title:

Impact of a Physical Activity Program on Bone Mineral Density (BMD) in Children / Adolescents With Chronic Inflammatory Bowel Disease (IBD): Crohn's Disease, Ulcerative Colitis, Unclassified Chronic Colitis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03774329
• Other study ID #: 2017_04
• Secondary ID: 2018-A00423-52
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: December 2023

Study information

• Verified date: February 2023
• Source: University Hospital, Lille
• Contact: Stéphanie COOPMAN, MD
• Phone: 0320445962
• Email: stephanie.coopman[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Muscle and physical activity play an important role in in growth, development and bone health in healthy children, especially during puberty. Children with inflammatory bowel disease (IBD) have lower level and intensity of physical compared to a control group. Several studies have shown that children with IBD have a lower bone mineral density (BMD) than general population, due to risk factors such as corticosteroid use, disease intensity, inflammation, malnutrition and a vitamin D deficiency. This low BMD is associated with an increased risk of fracture. A recent observational study found a positive and significant correlation between BMD in IBD patients and time spent in moderate to vigorous physical activity for one week (unpublished data).The present study aims to show a benefit of an adapted physical activity program on BMD in children and adolescents with IBD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• Patient with IBD (Crohn's disease, ulcerative colitis or unclassified chronic colitis) since at least 6 months.

• Computer and internet access at home.

• Consent to adhere to a physical activity program.

• Assent of the child to participation in the research protocol.

• Informed consent of parents or legal guardian.

• Patient benefiting from national health.

Exclusion Criteria:

• At time of inclusion, acute intercurrent events which may lead to a decrease in physical activity (according to the judgment of the investigator) as fractures, recent arthritis, ano-perineal lesions, severe dermatological lesions.

• Chronic, acute or intermittent diseases (other than IBD) that may lead to a decrease in physical activity.

• Refusal of the child to participate to the protocol.

• Refusal of one of the child's parents to participate in the protocol.

• Predictable lack of compliance to study procedures (especially to the physical activity program).

• Child with visual impairment.

• Participation in another interventional study.

• Pregnant or lactating women.

• Patient under protection of justice.

Related Conditions & MeSH terms

• Chronic; Colitis (Noninfective)
• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Enteritis
• Enteritis
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• Usual care
Patients included in the control group will not benefit from the intervention in adapted physical activity. However, this will not affect their support. Patients will be seen by their specialist doctor as part of the usual management of their IBD.
• adapted physical activity
Patients in the experimental group will have, in addition to their usual follow-up with their specialist doctor, an intervention in adapted physical activity at home, at the rate of 3 sessions (of a duration of 10 to 20 minutes) per week during 9 consecutive months.

Locations

Country	Name	City	State
France	Chu Amiens Picardie	Amiens
France	Hop Jeanne de Flandre Chu Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in total (whole body) Bone Mineral Density		At 9 months
Secondary	Change in vertebral BMD		At 9 months
Secondary	Change in femoral body BMD		At 9 months
Secondary	Change in time spent (minutes / day) in moderate to vigorous physical activity measured by accelerometry for 7 days		At 9 months
Secondary	Change in in fat mass measured by two-photon absorptiometry (%)		At 9 months
Secondary	Change in lean mass measured by two-photon absorptiometry (kg)		At 9 months
Secondary	Change IMPACT score III	related quality of life instrument in children with inflammatory bowel disease.	At 9 months
Secondary	Change in pediatrics crohn's disease activity index or pediatric ulcerative colitis activity index		At 9 months
Secondary	Change in biologic inflammatory parameters by decrease or increase C-reactive protein		At 9 months