Evaluation of the Benefits of Adaptive Physical Activity in Children and Adolescents With Osteogenesis Imperfecta (MOVE-OI)

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.

Study Overview

• Status: Completed
• Conditions: Osteogenesis Imperfecta
• Intervention / Treatment: Other: Adapted sports practices

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69500
    • Centre de Référence des Maladies Rénales Rares - Hospices Civils de Lyon - Service de Néphrologie et Rhumatologie Pédiatriques - Hôpital Femme Mère Enfant

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Adapted sports practices; Adapted sports practices for 30 minutes twice a week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	weight in kilograms will be measured with a scale	Month 0
Weight	weight in kilograms will be measured with a scale	Month 6
Weight	weight in kilograms will be measured with a scale	Month 12
Height	Size in meter measured with a meter	Month 0
Height	Size in meter measured with a meter	Month 6
Height	Size in meter measured with a meter	Month 12
body mass index	calculated with weight and height	Month 0
body mass index	calculated with weight and height	Month 6
body mass index	calculated with weight and height	Month 12
blood pressure	measurement of blood pressure (cm Hg)	Month 0
blood pressure	measurement of blood pressure (cm Hg)	Month 6
blood pressure	measurement of blood pressure (cm Hg)	Month 12
phosphocalcic biologic parameters	Ionosodium (mmol/L)	Month 0 and Month 12
phosphocalcic biologic parameters	potassium (mmol/L)	Month 0 and Month 12
phosphocalcic biologic parameters	calcium (mmol/L)	Month 0 and Month 12
phosphocalcic biologic parameters	chlore (mmol/L)	Month 0 and Month 12
phosphocalcic biologic parameters	bicarbonates (mmol/L)	Month 0 and Month 12
phosphocalcic biologic parameters	glucose (mmol/L)	Month 0 and Month 12
phosphocalcic biologic parameters	urea (mmol/L)	Month 0 and Month 12
phosphocalcic biologic parameters	creatinemia (mmol/L)	Month 0 and Month 12
phosphocalcic biologic parameters	phosphorus (mmol/L)	Month 0 and Month 12
phosphocalcic biologic parameters	proteinemia (g/L)	Month 0 and Month 12
phosphocalcic biologic parameters	Vitamin D (nmol/L)	Month 0 and Month 12
phosphocalcic biologic parameters	1-25 OH vitamin D (pmol/L)	Month 0 and Month 12
phosphocalcic biologic parameters	PTH (ng/L)	Month 0 and Month 12
phosphocalcic biologic parameters	alkaline bone phosphatases (U/L)	Month 0 and Month 12
phosphocalcic biologic parameters	CTX (pg/ml)crosslaps	Month 0 and Month 12
phosphocalcic biologic parameters	osteocalcin (µg/L)	Month 0 and Month 12
phosphocalcic biologic parameters	ferritin (µg/L)	Month 0 and Month 12
phosphocalcic biologic parameters	blood count formula : leucocytes (giga/L), erythrocytes (tera/L), hemoglobin (g/L), hematocrit (%), platelets (giga/L)	Month 0 and Month 12
phosphocalcic biologic parameters	calciuria (mmol/L)	Month 0 and Month 12
phosphocalcic biologic parameters	Ionosodium (mmol/L) potassium (mmol/L), calcium (mmol/L), chlore (mmol/L), bicarbonates (mmol/L), glucose (mmol/L), urea (mmol/L), creatinemia (mmol/L), phosphorus (mmol/L), proteinemia (g/L), Vitamin D (nmol/L), 1-25 OH vitamin D (pmol/L), PTH (ng/L), alkaline bone phosphatases (U/L), CTX (pg/ml)crosslaps, osteocalcin (µg/L), NFS, ferritin (µg/L), blood count formula : leucocytes (giga/L), erythrocytes (tera/L), hemoglobin (g/L), hematocrit (%), platelets (giga/L), calciuria (mmol/L), urinary creatinin (mmol/L).	Month 0 and Month 12
ration lean mass / fat mass	Dual-energy X-ray absorptiometry (DXA)	Month 0
ration lean mass / fat mass	Dual-energy X-ray absorptiometry (DXA)	Month 12
Respiratory Functional Exploration		Month 0
Respiratory Functional Exploration		Month 12
Thickness intima / media	echography	Month 0
Parameters of the connected watch : number of steps	data recovery of the connected watch	Month 0 and Month 6 and Month 12
Parameters of the connected watch : distance traveled	data recovery of the connected watch	Month 0 and Month 6 and Month 12
Parameters of the connected watch : calories consumption	data recovery of the connected watch	Month 0 and Month 6 and Month 12
Ratio thickness intima / media	echography	Month 12
Bone mineral density	Dual-energy X-ray absorptiometry (DXA)	Month 0
Bone mineral density	Dual-energy X-ray absorptiometry (DXA)	Month 12
Number of new fractures		Month 1
Number of new fractures		Month 3
Number of new fractures		Month 6
Number of new fractures		Month 9
Number of new fractures		Month 12
Quality of life questionnaire : PedsQL	Measurement Model for the Pedratric Quality of Life Inventory The 4 Multidimensional Scales and 3 Summary Scores are Scales Physical Functioning (8 items) Emotional Functioning (5 items) Social Functioning (5 items) School Functioning (5 items) Summary Scores Total Scale Score (23 items) Physical Health Summary Score (8 items) Psychosocial Health Summary Score (15 items)	Month 0
Quality of life questionnaire : PedsQL	Measurement Model for the Pedratric Quality of Life Inventory The 4 Multidimensional Scales and 3 Summary Scores are Scales Physical Functioning (8 items) Emotional Functioning (5 items) Social Functioning (5 items) School Functioning (5 items) Summary Scores Total Scale Score (23 items) Physical Health Summary Score (8 items) Psychosocial Health Summary Score (15 items)	Month 6
Quality of life questionnaire : PedsQL	Measurement Model for the Pedratric Quality of Life Inventory The 4 Multidimensional Scales and 3 Summary Scores are Scales Physical Functioning (8 items) Emotional Functioning (5 items) Social Functioning (5 items) School Functioning (5 items) Summary Scores Total Scale Score (23 items) Physical Health Summary Score (8 items) Psychosocial Health Summary Score (15 items)	Month 12

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Actual): October 14, 2022
• Study Completion (Actual): October 14, 2022

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 7, 2019
• First Posted (Actual): October 8, 2019

Study Record Updates

• Last Update Posted (Estimated): September 10, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Quality of life; osteogenesis imperfecta; Adapted sport
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Osteochondrodysplasias; Bone Diseases, Developmental; Collagen Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Osteogenesis Imperfecta
• Other Study ID Numbers: 69HCL18_0747; ID-RCB (Other Identifier: 2025-A02239-40)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No