Evaluation of the Benefits of Adaptive Physical Activity in Children and Adolescents With Osteogenesis Imperfecta
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- 6 minutes walk test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Adapted sports practices (Other)
Outcomes
Primary Outcomes
6 minutes walk test
Time Frame: Month 12
Distance traveled (in meters) in 6 minutes
6 minutes walk test
Time Frame: Month 6
Distance traveled (in meters) in 6 minutes
6 minutes walk test
Time Frame: Month 0
Distance traveled (in meters) in 6 minutes
Secondary Outcomes
- phosphocalcic biologic parameters(Month 0 and Month 12)
- Thickness intima / media(Month 0)
- Parameters of the connected watch : number of steps(Month 0 and Month 6 and Month 12)
- Ratio thickness intima / media(Month 12)
- Number of new fractures(Month 12)
- Weight(Month 12)
- ration lean mass / fat mass(Month 12)
- Bone mineral density(Month 12)
- Height(Month 12)
- body mass index(Month 12)
- Parameters of the connected watch : calories consumption(Month 0 and Month 6 and Month 12)
- blood pressure(Month 12)
- Parameters of the connected watch : distance traveled(Month 0 and Month 6 and Month 12)
- Quality of life questionnaire : PedsQL(Month 12)
- Respiratory Functional Exploration(Month 12)
- body mass index(Month 0)
- body mass index(Month 6)
- blood pressure(Month 0)
- blood pressure(Month 6)
- Height(Month 6)
- Weight(Month 0)
- Weight(Month 6)
- Height(Month 0)
- ration lean mass / fat mass(Month 0)
- Respiratory Functional Exploration(Month 0)
- Bone mineral density(Month 0)
- Number of new fractures(Month 1)
- Number of new fractures(Month 3)
- Number of new fractures(Month 6)
- Number of new fractures(Month 9)
- Quality of life questionnaire : PedsQL(Month 0)
- Quality of life questionnaire : PedsQL(Month 6)