Inflammatory Bowel DiseasePHYSICOSMICINCT02341742
Physical Activity and Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Disease, run by University Hospital, Lille at 7 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Inflammatory Bowel Disease
- What is being tested?
- multiple examinations
- Type of treatment
- Medical device
- How many people
- 84 participants
- Where
- 7 sitesFrance
- Study dates
- Oct 2014to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and Adolescents With Inflammatory Bowel Disease: Crohn´s disease and Ulcerative colitis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Chu Amiens-Picardie - Site Sud
Amiens
Centre Hospitalier
Arras
Centre hospitalier
Béthune
Centre Hospitalier
Lens
Clinical Investigation Center
Lille, Nord, 59037
Centre Hospitalier St Vincent
Lille
Centre Hospitalier
Roubaix
About this study
Official title: Relationship Between 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.
Read the detailed description
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.
- Conditions
- Inflammatory Bowel Disease
- Being tested
- multiple examinations
- Keywords
- Physical activity, Bone health, Pediatrics, Bone
- Medical subject headings
- Inflammatory Bowel Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multiple examinationsDevice
biological,clinical, X-ray, DXA, accelerometry assessment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: multiple examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 3 weeks
Secondary outcomes (5)
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
Measured: At 3 weeks
Dual energy-ray absorptiometry (Fat Free Mass)
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
Measured: At 3 weeks
Accelerometry ( Physical Activity)
We assess the Physical Activity with the accelerometry method during 7 consecutive days
Measured: 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
Measured: 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
Measured: At 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique TURCK, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02341742
- Sponsor's protocol ID
- 2013_69
- Other IDs
- 2014-A00685-42
- Acronym
- PHYSICOSMICI
- Status last verified
- Jan 2018
- First submitted
- 7 Jan 2015
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36735394
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Physical Activity and Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT02341742
- Acronym / sponsor ID
- PHYSICOSMICI / 2013_69
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Physical activity, Bone health, Pediatrics, Bone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Device: multiple examinationsfollow up of patients (children and adolescent) with inflammatory bowel disease in looking for the relationship between the bone mineral density and physical activity. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and Adolescents With Inflammatory Bowel Disease: Crohn´s disease and Ulcerative colitis
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multiple examinationsbiological,clinical, X-ray, DXA, accelerometry assessment | Device | Patients |
Primary outcome
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
5 secondary outcomes
Dual energy-ray absorptiometry (Fat Mass)
Time frame: At 3 weeks
Dual energy-ray absorptiometry (Fat Free Mass)
Time frame: At 3 weeks
Accelerometry ( Physical Activity)
Time frame: At 3 weeks
IMPACT III Questionnaire (quality of life)
Time frame: At 3 weeks
PedsQL Questionnaire (quality of life)
Time frame: At 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 36735394Vanhelst 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique TURCK, MD, PhD principal investigator
University Hospital, Lille
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease, run by University Hospital, Lille at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual energy-ray absorptiometry (bone mineral density) (time frame: At 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02341742, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.