MOVE-OI: Evaluation of the Benefits of Adaptive Physical Activity in Children and Adolescents With Osteogenesis Imperfecta
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 6 minutes walk test [Month 0]
Distance traveled (in meters) in 6 minutes
- 6 minutes walk test [Month 6]
Distance traveled (in meters) in 6 minutes
- 6 minutes walk test [Month 12]
Distance traveled (in meters) in 6 minutes
Secondary Outcome Measures
- Weight [Month 0]
weight in kilograms will be measured with a scale
- Weight [Month 6]
weight in kilograms will be measured with a scale
- Weight [Month 12]
weight in kilograms will be measured with a scale
- Height [Month 0]
Size in meter measured with a meter
- Height [Month 6]
Size in meter measured with a meter
- Height [Month 12]
Size in meter measured with a meter
- body mass index [Month 0]
calculated with weight and height
- body mass index [Month 6]
calculated with weight and height
- body mass index [Month 12]
calculated with weight and height
- blood pressure [Month 0]
measurement of blood pressure (cm Hg)
- blood pressure [Month 6]
measurement of blood pressure (cm Hg)
- blood pressure [Month 12]
measurement of blood pressure (cm Hg)
- phosphocalcic biologic parameters [Month 0 and Month 12]
Ionosodium (mmol/L)
- phosphocalcic biologic parameters [Month 0 and Month 12]
potassium (mmol/L)
- phosphocalcic biologic parameters [Month 0 and Month 12]
calcium (mmol/L)
- phosphocalcic biologic parameters [Month 0 and Month 12]
chlore (mmol/L)
- phosphocalcic biologic parameters [Month 0 and Month 12]
bicarbonates (mmol/L)
- phosphocalcic biologic parameters [Month 0 and Month 12]
glucose (mmol/L)
- phosphocalcic biologic parameters [Month 0 and Month 12]
urea (mmol/L)
- phosphocalcic biologic parameters [Month 0 and Month 12]
creatinemia (mmol/L)
- phosphocalcic biologic parameters [Month 0 and Month 12]
phosphorus (mmol/L)
- phosphocalcic biologic parameters [Month 0 and Month 12]
proteinemia (g/L)
- phosphocalcic biologic parameters [Month 0 and Month 12]
Vitamin D (nmol/L)
- phosphocalcic biologic parameters [Month 0 and Month 12]
1-25 OH vitamin D (pmol/L)
- phosphocalcic biologic parameters [Month 0 and Month 12]
PTH (ng/L)
- phosphocalcic biologic parameters [Month 0 and Month 12]
alkaline bone phosphatases (U/L)
- phosphocalcic biologic parameters [Month 0 and Month 12]
CTX (pg/ml)crosslaps
- phosphocalcic biologic parameters [Month 0 and Month 12]
osteocalcin (µg/L)
- phosphocalcic biologic parameters [Month 0 and Month 12]
ferritin (µg/L)
- phosphocalcic biologic parameters [Month 0 and Month 12]
blood count formula : leucocytes (giga/L), erythrocytes (tera/L), hemoglobin (g/L), hematocrit (%), platelets (giga/L)
- phosphocalcic biologic parameters [Month 0 and Month 12]
calciuria (mmol/L)
- 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).
- ration lean mass / fat mass [Month 0]
Dual-energy X-ray absorptiometry (DXA)
- ration lean mass / fat mass [Month 12]
Dual-energy X-ray absorptiometry (DXA)
- Respiratory Functional Exploration [Month 0]
- Respiratory Functional Exploration [Month 12]
- Thickness intima / media [Month 0]
echography
- Parameters of the connected watch : number of steps [Month 0 and Month 6 and Month 12]
data recovery of the connected watch
- Parameters of the connected watch : distance traveled [Month 0 and Month 6 and Month 12]
data recovery of the connected watch
- Parameters of the connected watch : calories consumption [Month 0 and Month 6 and Month 12]
data recovery of the connected watch
- Ratio thickness intima / media [Month 12]
echography
- Bone mineral density [Month 0]
Dual-energy X-ray absorptiometry (DXA)
- Bone mineral density [Month 12]
Dual-energy X-ray absorptiometry (DXA)
- 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 [Month 0]
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)
- Quality of life questionnaire : PedsQL [Month 6]
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)
- 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)
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre de Référence des Maladies Rénales Rares - Hospices Civils de Lyon - Service de Néphrologie et Rhumatologie Pédiatriques - Hôpital Femme Mère Enfant | Bron | France | 69500 |
Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 69HCL18_0747
- ID-RCB