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NCT Number: NCT03774329

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

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correlation between BMD in IBD patients and time spent in moderate to vigorous physical activity for one week (unpublished data).The present study aims to show a benefit of an adapted physical activity program on BMD in children and adolescents with IBD.

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Key information

Conditions

Crohn's Enteritis Behavior Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chronic; Colitis (Noninfective) Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Graft vs Host Disease Immune System Diseases Inflammatory Bowel Diseases Intestinal Diseases Lung Diseases Lung Diseases, Obstructive Motor Activity Organizing Pneumonia Respiratory Tract Diseases Ulcerative Colitis

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Amiens Picardie, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Usual Care

Other

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

Other

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 outcomes

  1. Change in total (whole body) Bone Mineral Density

    Time frame: At 9 months

Secondary outcomes

  1. Change in vertebral BMD

    Time frame: At 9 months

  2. Change in femoral body BMD

    Time frame: At 9 months

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

    Time frame: At 9 months

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

    Time frame: At 9 months

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

    Time frame: At 9 months

  6. Change IMPACT score III

    Time frame: At 9 months

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

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

    Time frame: At 9 months

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

    Time frame: At 9 months

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study 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

Acronym: PROPHYSICOS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 12, 2018
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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