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NCT Number: NCT02341742

Physical Activity and Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease

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.

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Key information

Conditions

Inflammatory Bowel Disease Behavior Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Motor Activity

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Investigation Center, Lille, Nord, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Boys or girls aged between 6 and 18 years old
  • Chronic, acute or intermittent diseas (other than IBD) that can lead to decreased physical activity (example: fracture, paralysis, blindness ...
  • Patient with IBD diagnosed since at least 6 months
  • Written informed consent obtained by the the parents and the patient
  • To have a health insurance

Exclusion criteria

  • Acute intercurrent events (less than 15 days) at the inclusion day leading to decreased physical activity according to the investigator judgment (fracture(s), recent arthritis, perineal lesions, severe skin lesions)
  • Patient refusing to participate to the study
  • One of the child's parents refusing to participate to the study
  • Lack of adherence foreseeable
  • Participation to another study
  • Pregnant girls
  • Under a justice protect measure

Treatment and study plan

multiple examinations

Device

biological,clinical, X-ray, DXA, accelerometry assessment

Primary outcomes

  1. Dual energy-ray absorptiometry (bone mineral density)

    Time frame: At 3 weeks

    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

Secondary outcomes

  1. Dual energy-ray absorptiometry (Fat Mass)

    Time frame: At 3 weeks

    We assess the Fat Mass with the Dual energy-ray absorptiometry method at the visit 2 corresponding at 3 weeks after the visit 1

  2. Dual energy-ray absorptiometry (Fat Free Mass)

    Time frame: At 3 weeks

    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

  3. Accelerometry ( Physical Activity)

    Time frame: At 3 weeks

    We assess the Physical Activity with the accelerometry method during 7 consecutive days

  4. IMPACT III Questionnaire (quality of life)

    Time frame: At 3 weeks

    We assess the quality of life throughout the IMPACT III questionnaire at the visit 2 corresponding at 3 weeks after the visit 1

  5. PedsQL Questionnaire (quality of life)

    Time frame: At 3 weeks

    We assess the quality of life throughout the PedsQL questionnaire at the visit 2 corresponding at 3 weeks after the visit 1

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Relationship Between Physical Activity and Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease

Acronym: PHYSICOSMICI

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 19, 2015
Registry last updated
May 14, 2026

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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