Clinical trial NCT04119388: Evaluation of the Benefits of Adaptive Physical Activity in Children and Adolescents With Osteogenesis Imperfecta
Official title: Evaluation of the Benefits of Adaptive Physical Activity in Children and Adolescents With Osteogenesis Imperfecta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteogenesis Imperfecta
Keywords: osteogenesis imperfecta
Adapted sport
Quality of life
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: 6 minutes walk test
timeFrame: Month 0
measure: 6 minutes walk test
timeFrame: Month 6
measure: 6 minutes walk test
timeFrame: Month 12
Secondary outcomes:
measure: Weight
timeFrame: Month 0
measure: Weight
timeFrame: Month 6
measure: Weight
timeFrame: Month 12
measure: Height
timeFrame: Month 0
measure: Height
timeFrame: Month 6
measure: Height
timeFrame: Month 12
measure: body mass index
timeFrame: Month 0
measure: body mass index
timeFrame: Month 6
measure: body mass index
timeFrame: Month 12
measure: blood pressure
timeFrame: Month 0
measure: blood pressure
timeFrame: Month 6
measure: blood pressure
timeFrame: Month 12
measure: phosphocalcic biologic parameters
timeFrame: Month 0 and Month 12
measure: phosphocalcic biologic parameters
timeFrame: Month 0 and Month 12
measure: phosphocalcic biologic parameters
timeFrame: Month 0 and Month 12
measure: phosphocalcic biologic parameters
timeFrame: Month 0 and Month 12
measure: phosphocalcic biologic parameters
timeFrame: Month 0 and Month 12
measure: phosphocalcic biologic parameters
timeFrame: Month 0 and Month 12
measure: phosphocalcic biologic parameters
timeFrame: Month 0 and Month 12
measure: phosphocalcic biologic parameters
timeFrame: Month 0 and Month 12
measure: phosphocalcic biologic parameters
timeFrame: Month 0 and Month 12
measure: phosphocalcic biologic parameters
timeFrame: Month 0 and Month 12
measure: phosphocalcic biologic parameters
timeFrame: Month 0 and Month 12
measure: phosphocalcic biologic parameters
timeFrame: Month 0 and Month 12
measure: phosphocalcic biologic parameters
timeFrame: Month 0 and Month 12
measure: phosphocalcic biologic parameters
timeFrame: Month 0 and Month 12
measure: phosphocalcic biologic parameters
timeFrame: Month 0 and Month 12
measure: phosphocalcic biologic parameters
timeFrame: Month 0 and Month 12
measure: phosphocalcic biologic parameters
timeFrame: Month 0 and Month 12
measure: phosphocalcic biologic parameters
timeFrame: Month 0 and Month 12
measure: phosphocalcic biologic parameters
timeFrame: Month 0 and Month 12
measure: phosphocalcic biologic parameters
timeFrame: Month 0 and Month 12
measure: ration lean mass / fat mass
timeFrame: Month 0
measure: ration lean mass / fat mass
timeFrame: Month 12
measure: Respiratory Functional Exploration
timeFrame: Month 0
measure: Respiratory Functional Exploration
timeFrame: Month 12
measure: Thickness intima / media
timeFrame: Month 0
measure: Parameters of the connected watch : number of steps
timeFrame: Month 0 and Month 6 and Month 12
measure: Parameters of the connected watch : distance traveled
timeFrame: Month 0 and Month 6 and Month 12
measure: Parameters of the connected watch : calories consumption
timeFrame: Month 0 and Month 6 and Month 12
measure: Ratio thickness intima / media
timeFrame: Month 12
measure: Bone mineral density
timeFrame: Month 0
measure: Bone mineral density
timeFrame: Month 12
measure: Number of new fractures
timeFrame: Month 1
measure: Number of new fractures
timeFrame: Month 3
measure: Number of new fractures
timeFrame: Month 6
measure: Number of new fractures
timeFrame: Month 9
measure: Number of new fractures
timeFrame: Month 12
measure: Quality of life questionnaire : PedsQL
timeFrame: Month 0
measure: Quality of life questionnaire : PedsQL
timeFrame: Month 6
measure: Quality of life questionnaire : PedsQL
timeFrame: Month 12
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre de Référence des Maladies Rénales Rares - Hospices Civils de Lyon - Service de Néphrologie et Rhumatologie Pédiatriques - Hôpital Femme Mère Enfant
Study officials:
References: