Adapted Physical Activity Program (APA) for Effort Rehabilitation of Children and Teenagers With Osteogenesis Imperfecta

Osteogenesis Imperfecta Clinical Trial

— BONeMOVE  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05927389
• Other study ID #: RC31/23/0248
• Status: Recruiting
• Phase: N/A
• Start date: February 26, 2024
• Est. completion date: July 15, 2026

Study information

• Verified date: February 2024
• Source: University Hospital, Toulouse
• Contact: Thomas EDOUARD, MD
• Phone: 05 61 77 61 10
• Email: edouard.t[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 15, 2026
• Est. primary completion date: July 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Non-walking children (unable to perform the effort test)

• Pregnant or breastfeeding

• Participation in other interventional research

Related Conditions & MeSH terms

• Osteogenesis Imperfecta

Intervention

Other:
• Adapted Physical Activity program
The Adaptated Physical Activity program consists of a Personalized Training Program adapted to each patient's condition and capacities

Locations

Country	Name	City	State
France	CHU Montpellier Hôpital Arnaud de Villeneuve	Montpellier
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (5)

Arponen 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. — View Citation

Harsevoort 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. — View Citation

Monti 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. — View Citation

Rossi 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline maximum endurance capacity at 6 months	Maximum oxygen consumption (VO2 peak) during an exercise test will be measured	Change from Baseline to 6 months
Secondary	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	Change from Baseline to 6 months
Secondary	Change from baseline number of steps at 6 months	6-minute walk test (6MWT) assessed by connected watch	Change from Baseline to 6 months
Secondary	Change from baseline Weight at 6 months	Body Mass Index	Change from Baseline to 6 months