Evaluation of the Benefits of Adaptive Physical Activity in Children and Adolescents With Osteogenesis Imperfecta

NCT ID: NCT04119388

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-04
• Study Completion Date: 2022-10-14

Brief Summary

Osteogenesis imperfecta (OI) is a rare genetic disorder of increased bone fragility and low bone mass. It is conceivable that children and adolescents with OI are less active than healthy peers because of frequent fractures, immobilization,functionals limitations and no adapted physicals activity(APA). The hypothesis is that an Adapted physique activity could improve access of activity for patients with Osteogenesis Imperfecta (OI).

The aim of the study is to evaluate benefice of APA,improve aerobic capacity, cardiovascular and bone benefits, and gain of quality of life.

Children with OI between 6 and 18 years old will have a program of supervised "adapted training program" during one year. The program is adapted at each individual and without risk for the patient.

Conditions

Osteogenesis Imperfecta

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Adapted sports practice

patients with osteogenesis imperfect will practice adapted sport twice a week during 12 months in order to improve their aerobic capacity, cardiovascular and bone benefits, and gain of quality of life.

Group Type: EXPERIMENTAL

Adapted sports practices

Intervention Type: OTHER

Adapted sports practices for 30 minutes twice a week

Interventions

Adapted sports practices

Adapted sports practices for 30 minutes twice a week

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Child with osteogenesis imperfecta
• Child followed in the Reference centre for constitutional bone diseases in the Hôpital Femme Mère Enfant
• Parent (s) / legal guardian who has been informed of the study and has accepted participation in the study by signing the consent.
• Patient benefiting from a social security scheme

Exclusion Criteria

• Medical and surgical contraindications to adapted physical activity.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre de Référence des Maladies Rénales Rares - Hospices Civils de Lyon - Service de Néphrologie et Rhumatologie Pédiatriques - Hôpital Femme Mère Enfant

Bron, , France

Countries

France

References

Al Arab H, Flammier S, Espitalier M, Bacchetta J, Fouillet-Desjonqueres M. Evaluation of the benefits of adapted physical activity in children and adolescents with osteogenesis imperfecta: the MOVE-OI trial. Orphanet J Rare Dis. 2025 Apr 12;20(1):175. doi: 10.1186/s13023-025-03678-4.

Reference Type: BACKGROUND

PMID: 40221747 (View on PubMed)

Other Identifiers

ID-RCB

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL18_0747

Identifier Type: -

Identifier Source: org_study_id