Crohn's EnteritisPROPHYSICOSNCT03774329
Impact of a Physical Activity Program on Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease
A study testing adapted physical activity in people with Crohn's Enteritis and Crohn Disease, run by University Hospital, Lille at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Crohn's Enteritis, Crohn Disease, Ulcerative Colitis
- What is being tested?
- adapted physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesFrance
- Study dates
- 2 Mar 2020to 8 Dec 2021
- Phase
- Interventional
- 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
Who may be able to join
- 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.
Who cannot join
- 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.
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- Participation in another interventional study.
- Pregnant or lactating women.
- Patient under protection of justice.
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
- Being tested
- Usual care, adapted physical activity
- Keywords
- inflammatory bowel disease, physical activity, bone mineral density, pediatric
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative, Bronchiolitis Obliterans Syndrome, Colitis, Inflammatory Bowel Diseases, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
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 activityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| physical activity program | Experimental | Child with an adapted physical activity program Receives: Other: adapted physical activity |
| Usual care | Other | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total (whole body) Bone Mineral Density
Measured: At 9 months
Secondary outcomes (8)
Change in vertebral BMD
Measured: At 9 months
Change in femoral body BMD
Measured: At 9 months
Change in time spent (minutes / day) in moderate to vigorous physical activity measured by accelerometry for 7 days
Measured: At 9 months
Change in in fat mass measured by two-photon absorptiometry (%)
Measured: At 9 months
Change in lean mass measured by two-photon absorptiometry (kg)
Measured: At 9 months
Change IMPACT score III
related quality of life instrument in children with inflammatory bowel disease.
Measured: At 9 months
Change in pediatrics crohn's disease activity index or pediatric ulcerative colitis activity index
Measured: At 9 months
Change in biologic inflammatory parameters by decrease or increase C-reactive protein
Measured: At 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start2 Mar 2020
- Primary completion8 Dec 2021
- Study completion8 Dec 2021
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 Crohn's EnteritisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie COOPMAN, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774329
- Sponsor's protocol ID
- 2017_04
- Other IDs
- 2018-A00423-52
- Acronym
- PROPHYSICOS
- Status last verified
- Dec 2021
- First submitted
- 3 Dec 2018
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32430452
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03774329
- Acronym / sponsor ID
- PROPHYSICOS / 2017_04
- Keywords
- inflammatory bowel disease, physical activity, bone mineral density, pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 12 Dec 2018 (actual)
- 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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physical activity program | Experimental | Other: adapted physical activityChild with an adapted physical activity program |
| Usual care | Other | Other: Usual care |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
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 |
|---|---|---|
| Usual carePatients 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. | Other | Usual care |
| adapted physical activityPatients 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. | Other | physical activity program |
Primary outcome
Change in total (whole body) Bone Mineral Density
Time frame: At 9 months
8 secondary outcomes
Change in vertebral BMD
Time frame: At 9 months
Change in femoral body BMD
Time frame: At 9 months
Change in time spent (minutes / day) in moderate to vigorous physical activity measured by accelerometry for 7 days
Time frame: At 9 months
Change in in fat mass measured by two-photon absorptiometry (%)
Time frame: At 9 months
Change in lean mass measured by two-photon absorptiometry (kg)
Time frame: At 9 months
Change IMPACT score III
Time frame: At 9 months
Change in pediatrics crohn's disease activity index or pediatric ulcerative colitis activity index
Time frame: At 9 months
Change in biologic inflammatory parameters by decrease or increase C-reactive protein
Time frame: At 9 months
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 23 Dec 2025.
- Results publication: PubMed 32430452Vanhelst 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.
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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.
Stéphanie COOPMAN, MD principal investigator
University Hospital, Lille
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adapted physical activity in people with Crohn's Enteritis and Crohn Disease, run by University Hospital, Lille at 2 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 6 inclusion and 9 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 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Change in total (whole body) Bone Mineral Density (time frame: At 9 months). 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 NCT03774329, 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 23 Dec 2025.