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

NCT04119388 | Completed

• 2 other identifiers: 69HCL18_0747ID-RCB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

osteogenesis imperfecta; Adapted sport; Quality of life

Outcome Measures

Primary Outcomes (3)

• 6 minutes walk test

  Distance traveled (in meters) in 6 minutes

  Month 0

• 6 minutes walk test

  Distance traveled (in meters) in 6 minutes

  Month 6

• 6 minutes walk test

  Distance traveled (in meters) in 6 minutes

  Month 12

Secondary Outcomes (51)

• Weight

  Month 0

• Weight

  Month 6

• Weight

  Month 12

• Height

  Month 0

• Height

  Month 6

Study Arms (1)

Adapted sports practice

EXPERIMENTAL

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.

Other: Adapted sports practices

Interventions

Adapted sports practices OTHER

Adapted sports practices for 30 minutes twice a week

Adapted sports practice

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Medical and surgical contraindications to adapted physical activity.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

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

Bron, 69500, France

Location

Related Publications (1)

• 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.

  PMID: 40221747 BACKGROUND

MeSH Terms

Conditions

Osteogenesis Imperfecta

Condition Hierarchy (Ancestors)

Osteochondrodysplasias; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2019
• First Posted: October 8, 2019
• Study Start: November 4, 2019
• Primary Completion: October 14, 2022
• Study Completion: October 14, 2022
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

FR (1)