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

Primary Purpose

Crohn's Enteritis, Crohn Disease, Ulcerative Colitis

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Usual care

adapted physical activity

About this trial

This is an interventional supportive care trial for Crohn's Enteritis focused on measuring inflammatory bowel disease, physical activity, bone mineral density, pediatric

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Chu Amiens PicardieRecruiting
Hop Jeanne de Flandre Chu LilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

physical activity program

Usual care

Arm Description

Child with an adapted physical activity program

Outcomes

Primary Outcome Measures

Change in total (whole body) Bone Mineral Density

Secondary Outcome Measures

Change in vertebral BMD

Change in femoral body BMD

Change in time spent (minutes / day) in moderate to vigorous physical activity measured by accelerometry for 7 days

Change in in fat mass measured by two-photon absorptiometry (%)

Change in lean mass measured by two-photon absorptiometry (kg)

Change IMPACT score III

related quality of life instrument in children with inflammatory bowel disease.

Change in pediatrics crohn's disease activity index or pediatric ulcerative colitis activity index

Change in biologic inflammatory parameters by decrease or increase C-reactive protein

Full Information

NCT ID

NCT03774329

First Posted

December 3, 2018

Last Updated

February 6, 2023

Sponsor

University Hospital, Lille

1. Study Identification

Unique Protocol Identification Number

NCT03774329

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 2, 2020 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Enteritis, Crohn Disease, Ulcerative Colitis, Chronic; Colitis (Noninfective)

Keywords

inflammatory bowel disease, physical activity, bone mineral density, pediatric

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

physical activity program

Arm Type

Experimental

Arm Description

Child with an adapted physical activity program

Arm Title

Usual care

Arm Type

Other

Intervention Type

Other

Intervention Name(s)

Usual care

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

adapted physical activity

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in total (whole body) Bone Mineral Density

Time Frame

At 9 months

Secondary Outcome Measure Information:

Title

Change in vertebral BMD

Time Frame

At 9 months

Title

Change in femoral body BMD

Time Frame

At 9 months

Title

Change in time spent (minutes / day) in moderate to vigorous physical activity measured by accelerometry for 7 days

Time Frame

At 9 months

Title

Change in in fat mass measured by two-photon absorptiometry (%)

Time Frame

At 9 months

Title

Change in lean mass measured by two-photon absorptiometry (kg)

Time Frame

At 9 months

Title

Change IMPACT score III

Description

related quality of life instrument in children with inflammatory bowel disease.

Time Frame

At 9 months

Title

Change in pediatrics crohn's disease activity index or pediatric ulcerative colitis activity index

Time Frame

At 9 months

Title

Change in biologic inflammatory parameters by decrease or increase C-reactive protein

Time Frame

At 9 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Stéphanie COOPMAN, MD

Phone

0320445962

Ext

+33

stephanie.coopman@chru-lille.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stéphanie COOPMAN, MD

Organizational Affiliation

University Hospital, Lille

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chu Amiens Picardie

City

Amiens

Country

France

Individual Site Status

Recruiting

Facility Name

Hop Jeanne de Flandre Chu Lille

City

Lille

Country

France

Individual Site Status

Recruiting

12. IPD Sharing Statement

Citations:

PubMed Identifier

32430452

Citation

Vanhelst J, Coopman S, Labreuche J, Dupont C, Bertrand V, Djeddi D, Turck D, Ley D. Protocol of a randomised controlled trial assessing the impact of physical activity on bone health in children with inflammatory bowel disease. BMJ Open. 2020 May 18;10(5):e036400. doi: 10.1136/bmjopen-2019-036400.

Results Reference

derived

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

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