Osteogenesis ImperfectaBONeMOVENCT05927389
Adapted Physical Activity Program (APA) for Effort Rehabilitation of Children and Teenagers With Osteogenesis Imperfecta
A study testing Adapted Physical Activity program in people with Osteogenesis Imperfecta, run by University Hospital, Toulouse at 2 sites in France.
Trial summary
This research study aims to evaluate the effect of a 6-month adapted physical activity program (APA) on the endurance capacities (evaluated as the maximum oxygen consumption [VO2 peak]) of children and adolescents with Osteogenesis Imperfecta. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Osteogenesis Imperfecta
- What is being tested?
- Adapted Physical Activity program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Feb 2024to 26 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed Osteogenesis Imperfecta
- Informed and written consent signed by at least one of the two holders of parental authority
- Patient affiliated to a social security scheme or equivalent
Who cannot join
- Non-walking children (unable to perform the effort test)
- Pregnant or breastfeeding
- Participation in other interventional research
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Marjolaine WILLEMS, MD contact
France2 sites, 2 recruiting
- Not yet recruiting
CHU Montpellier Hôpital Arnaud de Villeneuve
Montpellier
Marjolaine WILLEMS, MD
m-willems@chu-montpellier.fr
- Recruiting
CHU Toulouse
Toulouse
Thomas EDOUARD, MD, 05 61 77 61 10, edouard.t@chu-toulouse.fr
About this study
Official title: BONeMOVE : an Adapted Physical Activity Program (APA) for Effort Rehabilitation of Children and Teenagers With Osteogenesis Imperfecta: an Interventional, Prospective, Regional, Bicentric Study.
This research study aims to evaluate the effect of a 6-month adapted physical activity program (APA) on the endurance capacities (evaluated as the maximum oxygen consumption [VO2 peak]) of children and adolescents with Osteogenesis Imperfecta.
Read the detailed description
Osteogenesis Imperfecta (OI) is a rare genetic disease characterised mainly by bone fragility, decreased bone mass and a susceptibility to fractures of varying severity. Different forms have been described according to the severity of the bone manifestations. Although it is a genetically heterogeneous disease, approximately 90% of OI patients have a mutation in the gene encoding gene encoding type 1 collagen, a major component of the extracellular matrix.
Chronic fatigue and decreased physical endurance are almost constant complaints of patients with OI (more than 95% according to some studies), which impacts the activities of daily living and quality of life of these patients. The causes of this decrease in endurance are multifactorial involving prolonged immobilisation secondary to fractures, chronic osteoarticular pain, but also primary muscle damage.
Mechanography studies carried out in children with OI have shown a significant deficit in muscle function in terms of both strength and power.
In healthy adults, physical inactivity is an important predictor of feeling of tired. In addition, in some chronic diseases (such as multiple sclerosis, rheumatoid arthritis or systemic lupus erythematosus), physical activity and training have been shown to be effective in improving muscle strength and functional capacity as well as fatigue and quality of life. In OI, it has been reported that physical activity improves muscle function and bone mass. Patients with OI should therefore benefit from a regular exercise programme taking into account their risk of fracture.
This study aims to evaluate the effect of a life-skills physical activity (LSPA) programme on the endurance capacities and quality of life of children and adolescents with OI.
The VO2 peak evolution will be evaluated after 6 months of program. This is a recognized parameter for the evaluation of endurance and has been validated in children. The hypothesis of this study is that the implementation of a physical activity program adapted to the daily life and interests of the child with OI will efficiently improve endurance, prevent deconditioning and promote long term benefits.
- Conditions
- Osteogenesis Imperfecta
- Being tested
- Adapted Physical Activity program
- Keywords
- Osteogenesis Imperfecta, Children, Adolescents, Maximum oxygen consumption, Adapted physical activity, Effort rehabilitation
- Medical subject headings
- Osteogenesis Imperfecta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Physical Activity programOther
The Adaptated Physical Activity program consists of a Personalized Training Program adapted to each patient's condition and capacities
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: 6 months APA program | Experimental | The various assessments will be carried out during 2 visits at 6 months interval as part of the usual follow-up at the "Constitutional Bone Diseases" unit at the Toulouse University Hospital.
The APA program built from the initial assessment will be returned to the child and his family during a videoconference.
In addition, a regular reassessment and adjustment of this program will be made every 15 days during phone calls by the APA coach. Receives: Other: Adapted Physical Activity program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline maximum endurance capacity at 6 months
Maximum oxygen consumption (VO2 peak) during an exercise test will be measured
Measured: Change from Baseline to 6 months
Secondary outcomes (3)
Change from baseline quality of life questionnaire score at 6 months
Osteogenesis Imperfecta Specific Quality of Life Questionnaire (OIQoL). Total scores are based on a 0-100 scale, where a high score represents better quality of life
Measured: Change from Baseline to 6 months
Change from baseline number of steps at 6 months
6-minute walk test (6MWT) assessed by connected watch
Measured: Change from Baseline to 6 months
Change from baseline Weight at 6 months
Body Mass Index
Measured: Change from Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start26 Feb 2024
- Primary completion26 Aug 2027 (estimated)
- Study completion26 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Osteogenesis ImperfectaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas EDOUARD, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927389
- Sponsor's protocol ID
- RC31/23/0248
- Acronym
- BONeMOVE
- Status last verified
- May 2026
- First submitted
- 13 Jun 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sillence DO, Senn A, Danks DM. Genetic heterogeneity in osteogenesis imperfecta. J Med Genet. 1979 Apr;16(2):101-16. doi: 10.1136/jmg.16.2.101.
PubMed 458828Rossi V, Lee B, Marom R. Osteogenesis imperfecta: advancements in genetics and treatment. Curr Opin Pediatr. 2019 Dec;31(6):708-715. doi: 10.1097/MOP.0000000000000813.
PubMed 31693577Monti E, Mottes M, Fraschini P, Brunelli P, Forlino A, Venturi G, Doro F, Perlini S, Cavarzere P, Antoniazzi F. Current and emerging treatments for the management of osteogenesis imperfecta. Ther Clin Risk Manag. 2010 Sep 7;6:367-81. doi: 10.2147/tcrm.s5932.
PubMed 20856683Arponen H, Waltimo-Siren J, Valta H, Makitie O. Fatigue and disturbances of sleep in patients with osteogenesis imperfecta - a cross-sectional questionnaire study. BMC Musculoskelet Disord. 2018 Jan 8;19(1):3. doi: 10.1186/s12891-017-1922-5.
PubMed 29310646Harsevoort AGJ, Gooijer K, van Dijk FS, van der Grijn DAFM, Franken AAM, Dommisse AMV, Janus GJM. Fatigue in adults with Osteogenesis Imperfecta. BMC Musculoskelet Disord. 2020 Jan 3;21(1):6. doi: 10.1186/s12891-019-3000-7.
PubMed 31900144
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BONeMOVE : an Adapted Physical Activity Program (APA) for Effort Rehabilitation of Children and Teenagers With Osteogenesis Imperfecta: an Interventional, Prospective, Regional, Bicentric Study.
- ClinicalTrials.gov ID
- NCT05927389
- Acronym / sponsor ID
- BONeMOVE / RC31/23/0248
- Conditions
- Osteogenesis Imperfecta
- Keywords
- Osteogenesis Imperfecta, Children, Adolescents, Maximum oxygen consumption, Adapted physical activity, Effort rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 26 Aug 2027 (estimated)
- Study completion
- 26 Aug 2027 (estimated)
- First posted
- 3 Jul 2023 (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.
This research study aims to evaluate the effect of a 6-month adapted physical activity program (APA) on the endurance capacities (evaluated as the maximum oxygen consumption [VO2 peak]) of children and adolescents with Osteogenesis Imperfecta.
Detailed description
Osteogenesis Imperfecta (OI) is a rare genetic disease characterised mainly by bone fragility, decreased bone mass and a susceptibility to fractures of varying severity. Different forms have been described according to the severity of the bone manifestations. Although it is a genetically heterogeneous disease, approximately 90% of OI patients have a mutation in the gene encoding gene encoding type 1 collagen, a major component of the extracellular matrix.
Chronic fatigue and decreased physical endurance are almost constant complaints of patients with OI (more than 95% according to some studies), which impacts the activities of daily living and quality of life of these patients. The causes of this decrease in endurance are multifactorial involving prolonged immobilisation secondary to fractures, chronic osteoarticular pain, but also primary muscle damage.
Mechanography studies carried out in children with OI have shown a significant deficit in muscle function in terms of both strength and power.
In healthy adults, physical inactivity is an important predictor of feeling of tired. In addition, in some chronic diseases (such as multiple sclerosis, rheumatoid arthritis or systemic lupus erythematosus), physical activity and training have been shown to be effective in improving muscle strength and functional capacity as well as fatigue and quality of life. In OI, it has been reported that physical activity improves muscle function and bone mass. Patients with OI should therefore benefit from a regular exercise programme taking into account their risk of fracture.
This study aims to evaluate the effect of a life-skills physical activity (LSPA) programme on the endurance capacities and quality of life of children and adolescents with OI.
The VO2 peak evolution will be evaluated after 6 months of program. This is a recognized parameter for the evaluation of endurance and has been validated in children. The hypothesis of this study is that the implementation of a physical activity program adapted to the daily life and interests of the child with OI will efficiently improve endurance, prevent deconditioning and promote long term benefits.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group: 6 months APA program | Experimental | Other: Adapted Physical Activity programThe various assessments will be carried out during 2 visits at 6 months interval as part of the usual follow-up at the "Constitutional Bone Diseases" unit at the Toulouse University Hospital. The APA program built from the initial assessment will be returned to the child and his family during a videoconference. In addition, a regular reassessment and adjustment of this program will be made every 15 days during phone calls by the APA coach. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosed Osteogenesis Imperfecta
- Informed and written consent signed by at least one of the two holders of parental authority
- Patient affiliated to a social security scheme or equivalent
Key exclusion criteria (3 listed)
- Non-walking children (unable to perform the effort test)
- Pregnant or breastfeeding
- Participation in other interventional research
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 |
|---|---|---|
| Adapted Physical Activity programThe Adaptated Physical Activity program consists of a Personalized Training Program adapted to each patient's condition and capacities | Other | Experimental group: 6 months APA program |
Primary outcome
Change from Baseline maximum endurance capacity at 6 months
Time frame: Change from Baseline to 6 months
Maximum oxygen consumption (VO2 peak) during an exercise test will be measured
3 secondary outcomes
Change from baseline quality of life questionnaire score at 6 months
Time frame: Change from Baseline to 6 months
Change from baseline number of steps at 6 months
Time frame: Change from Baseline to 6 months
Change from baseline Weight at 6 months
Time frame: Change from Baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 458828Sillence DO, Senn A, Danks DM. Genetic heterogeneity in osteogenesis imperfecta. J Med Genet. 1979 Apr;16(2):101-16. doi: 10.1136/jmg.16.2.101.
- Background: PubMed 31693577Rossi V, Lee B, Marom R. Osteogenesis imperfecta: advancements in genetics and treatment. Curr Opin Pediatr. 2019 Dec;31(6):708-715. doi: 10.1097/MOP.0000000000000813.
- Background: PubMed 20856683Monti E, Mottes M, Fraschini P, Brunelli P, Forlino A, Venturi G, Doro F, Perlini S, Cavarzere P, Antoniazzi F. Current and emerging treatments for the management of osteogenesis imperfecta. Ther Clin Risk Manag. 2010 Sep 7;6:367-81. doi: 10.2147/tcrm.s5932.
- Background: PubMed 29310646Arponen H, Waltimo-Siren J, Valta H, Makitie O. Fatigue and disturbances of sleep in patients with osteogenesis imperfecta - a cross-sectional questionnaire study. BMC Musculoskelet Disord. 2018 Jan 8;19(1):3. doi: 10.1186/s12891-017-1922-5.
- Background: PubMed 31900144Harsevoort AGJ, Gooijer K, van Dijk FS, van der Grijn DAFM, Franken AAM, Dommisse AMV, Janus GJM. Fatigue in adults with Osteogenesis Imperfecta. BMC Musculoskelet Disord. 2020 Jan 3;21(1):6. doi: 10.1186/s12891-019-3000-7.
- Individual participant dataSharing planned: No
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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.
Marjolaine WILLEMS, MD contact
Thomas EDOUARD, MD principal investigator
University Hospital, Toulouse
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 program in people with Osteogenesis Imperfecta, run by University Hospital, Toulouse 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 8 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas EDOUARD, MD (05 61 77 61 10, edouard.t@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline maximum endurance capacity at 6 months (time frame: Change from Baseline to 6 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 NCT05927389, which also lists 5 linked publications.
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 8 May 2026.