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

Osteogenesis Imperfecta Clinical Trial

— MOVE-OI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04119388
• Other study ID #: 69HCL18_0747
• Secondary ID: ID-RCB
• Status: Completed
• Phase: N/A
• Start date: November 4, 2019
• Est. completion date: October 14, 2022

Study information

• Verified date: January 2023
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 14, 2022
• Est. primary completion date: October 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteogenesis Imperfecta

Intervention

Other:
• Adapted sports practices
Adapted sports practices for 30 minutes twice a week

Locations

Country	Name	City	State
France	Centre de Référence des Maladies Rénales Rares - Hospices Civils de Lyon - Service de Néphrologie et Rhumatologie Pédiatriques - Hôpital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6 minutes walk test	Distance traveled (in meters) in 6 minutes	Month 0
Primary	6 minutes walk test	Distance traveled (in meters) in 6 minutes	Month 6
Primary	6 minutes walk test	Distance traveled (in meters) in 6 minutes	Month 12
Secondary	Weight	weight in kilograms will be measured with a scale	Month 0
Secondary	Weight	weight in kilograms will be measured with a scale	Month 6
Secondary	Weight	weight in kilograms will be measured with a scale	Month 12
Secondary	Height	Size in meter measured with a meter	Month 0
Secondary	Height	Size in meter measured with a meter	Month 6
Secondary	Height	Size in meter measured with a meter	Month 12
Secondary	body mass index	calculated with weight and height	Month 0
Secondary	body mass index	calculated with weight and height	Month 6
Secondary	body mass index	calculated with weight and height	Month 12
Secondary	blood pressure	measurement of blood pressure (cm Hg)	Month 0
Secondary	blood pressure	measurement of blood pressure (cm Hg)	Month 6
Secondary	blood pressure	measurement of blood pressure (cm Hg)	Month 12
Secondary	phosphocalcic biologic parameters	Ionosodium (mmol/L)	Month 0 and Month 12
Secondary	phosphocalcic biologic parameters	potassium (mmol/L)	Month 0 and Month 12
Secondary	phosphocalcic biologic parameters	calcium (mmol/L)	Month 0 and Month 12
Secondary	phosphocalcic biologic parameters	chlore (mmol/L)	Month 0 and Month 12
Secondary	phosphocalcic biologic parameters	bicarbonates (mmol/L)	Month 0 and Month 12
Secondary	phosphocalcic biologic parameters	glucose (mmol/L)	Month 0 and Month 12
Secondary	phosphocalcic biologic parameters	urea (mmol/L)	Month 0 and Month 12
Secondary	phosphocalcic biologic parameters	creatinemia (mmol/L)	Month 0 and Month 12
Secondary	phosphocalcic biologic parameters	phosphorus (mmol/L)	Month 0 and Month 12
Secondary	phosphocalcic biologic parameters	proteinemia (g/L)	Month 0 and Month 12
Secondary	phosphocalcic biologic parameters	Vitamin D (nmol/L)	Month 0 and Month 12
Secondary	phosphocalcic biologic parameters	1-25 OH vitamin D (pmol/L)	Month 0 and Month 12
Secondary	phosphocalcic biologic parameters	PTH (ng/L)	Month 0 and Month 12
Secondary	phosphocalcic biologic parameters	alkaline bone phosphatases (U/L)	Month 0 and Month 12
Secondary	phosphocalcic biologic parameters	CTX (pg/ml)crosslaps	Month 0 and Month 12
Secondary	phosphocalcic biologic parameters	osteocalcin (µg/L)	Month 0 and Month 12
Secondary	phosphocalcic biologic parameters	ferritin (µg/L)	Month 0 and Month 12
Secondary	phosphocalcic biologic parameters	blood count formula : leucocytes (giga/L), erythrocytes (tera/L), hemoglobin (g/L), hematocrit (%), platelets (giga/L)	Month 0 and Month 12
Secondary	phosphocalcic biologic parameters	calciuria (mmol/L)	Month 0 and Month 12
Secondary	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
Secondary	ration lean mass / fat mass	Dual-energy X-ray absorptiometry (DXA)	Month 0
Secondary	ration lean mass / fat mass	Dual-energy X-ray absorptiometry (DXA)	Month 12
Secondary	Respiratory Functional Exploration		Month 0
Secondary	Respiratory Functional Exploration		Month 12
Secondary	Thickness intima / media	echography	Month 0
Secondary	Parameters of the connected watch : number of steps	data recovery of the connected watch	Month 0 and Month 6 and Month 12
Secondary	Parameters of the connected watch : distance traveled	data recovery of the connected watch	Month 0 and Month 6 and Month 12
Secondary	Parameters of the connected watch : calories consumption	data recovery of the connected watch	Month 0 and Month 6 and Month 12
Secondary	Ratio thickness intima / media	echography	Month 12
Secondary	Bone mineral density	Dual-energy X-ray absorptiometry (DXA)	Month 0
Secondary	Bone mineral density	Dual-energy X-ray absorptiometry (DXA)	Month 12
Secondary	Number of new fractures		Month 1
Secondary	Number of new fractures		Month 3
Secondary	Number of new fractures		Month 6
Secondary	Number of new fractures		Month 9
Secondary	Number of new fractures		Month 12
Secondary	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
Secondary	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
Secondary	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