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

Not Applicable

Completed

• Conditions: Osteogenesis Imperfecta
• Interventions: Other: Adapted sports practices

• Registration Number: NCT04119388
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2019-10-07
• Study First Posted: 2019-10-08
• Study Start: 2019-11-04
• Primary Completion: 2022-10-14
• Study Completion: 2022-10-14
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

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Exclusion Criteria

• Medical and surgical contraindications to adapted physical activity.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adapted sports practice	Adapted sports practices	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.

Primary Outcome Measures

Name	Time	Method
6 minutes walk test	Month 12	Distance traveled (in meters) in 6 minutes

Secondary Outcome Measures

Name	Time	Method
Number of new fractures	Month 12
Weight	Month 12	weight in kilograms will be measured with a scale
Height	Month 12	Size in meter measured with a meter
body mass index	Month 12	calculated with weight and height
Parameters of the connected watch : calories consumption	Month 0 and Month 6 and Month 12	data recovery of the connected watch
Bone mineral density	Month 12	Dual-energy X-ray absorptiometry (DXA)
blood pressure	Month 12	measurement of blood pressure (cm Hg)
ration lean mass / fat mass	Month 12	Dual-energy X-ray absorptiometry (DXA)
Thickness intima / media	Month 0	echography
Parameters of the connected watch : distance traveled	Month 0 and Month 6 and Month 12	data recovery of the connected watch
Quality of life questionnaire : PedsQL	Month 12	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)
phosphocalcic biologic parameters	Month 0 and Month 12	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).
Parameters of the connected watch : number of steps	Month 0 and Month 6 and Month 12	data recovery of the connected watch
Ratio thickness intima / media	Month 12	echography
Respiratory Functional Exploration	Month 12

Trial Locations

Locations (1)

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