An interventional study of Adapted Physical Activity program in Osteogenesis Imperfecta, sponsored by University Hospital, Toulouse. Recruiting at 2 sites in France. Open to participants aged 7 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Prevention
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.
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.
84 studies on the registry are indexed under Osteogenesis Imperfecta; 20 are open to participants now.
This study's planned enrollment of 30 is close to the median of 28 across 60 interventional studies indexed under Osteogenesis Imperfecta.
Browse Osteogenesis Imperfecta studies →University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: Adapted Physical Activity program
The Adaptated Physical Activity program consists of a Personalized Training Program adapted to each patient's condition and capacities
Change from Baseline maximum endurance capacity at 6 months
Maximum oxygen consumption (VO2 peak) during an exercise test will be measured
Time frame: Change from Baseline to 6 months
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
Time frame: Change from Baseline to 6 months
Change from baseline number of steps at 6 months
6-minute walk test (6MWT) assessed by connected watch
Time frame: Change from Baseline to 6 months
Change from baseline Weight at 6 months
Body Mass Index
Time frame: Change from Baseline to 6 months
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Toulouse →