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Completed

NCT Number: NCT04119388

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

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.

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Key information

Conditions

Osteogenesis Imperfecta Bone Diseases Bone Diseases, Developmental Collagen Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Osteochondrodysplasias Skin and Connective Tissue Diseases

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de Référence des Maladies Rénales Rares - Hospices Civils de Lyon - Service de Néphrologie et Rhumatologie Pédiatriques - Hôpital Femme Mère Enfant

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adapted sports practices

Other

Adapted sports practices for 30 minutes twice a week

Primary outcomes

  1. 6 minutes walk test

    Time frame: Month 0

    Distance traveled (in meters) in 6 minutes

  2. 6 minutes walk test

    Time frame: Month 6

    Distance traveled (in meters) in 6 minutes

  3. 6 minutes walk test

    Time frame: Month 12

    Distance traveled (in meters) in 6 minutes

Secondary outcomes

  1. Weight

    Time frame: Month 0

    weight in kilograms will be measured with a scale

  2. Weight

    Time frame: Month 6

    weight in kilograms will be measured with a scale

  3. Weight

    Time frame: Month 12

    weight in kilograms will be measured with a scale

  4. Height

    Time frame: Month 0

    Size in meter measured with a meter

  5. Height

    Time frame: Month 6

    Size in meter measured with a meter

  6. Height

    Time frame: Month 12

    Size in meter measured with a meter

  7. body mass index

    Time frame: Month 0

    calculated with weight and height

  8. body mass index

    Time frame: Month 6

    calculated with weight and height

  9. body mass index

    Time frame: Month 12

    calculated with weight and height

  10. blood pressure

    Time frame: Month 0

    measurement of blood pressure (cm Hg)

  11. blood pressure

    Time frame: Month 6

    measurement of blood pressure (cm Hg)

  12. blood pressure

    Time frame: Month 12

    measurement of blood pressure (cm Hg)

  13. phosphocalcic biologic parameters

    Time frame: Month 0 and Month 12

    Ionosodium (mmol/L)

  14. phosphocalcic biologic parameters

    Time frame: Month 0 and Month 12

    potassium (mmol/L)

  15. phosphocalcic biologic parameters

    Time frame: Month 0 and Month 12

    calcium (mmol/L)

  16. phosphocalcic biologic parameters

    Time frame: Month 0 and Month 12

    chlore (mmol/L)

  17. phosphocalcic biologic parameters

    Time frame: Month 0 and Month 12

    bicarbonates (mmol/L)

  18. phosphocalcic biologic parameters

    Time frame: Month 0 and Month 12

    glucose (mmol/L)

  19. phosphocalcic biologic parameters

    Time frame: Month 0 and Month 12

    urea (mmol/L)

  20. phosphocalcic biologic parameters

    Time frame: Month 0 and Month 12

    creatinemia (mmol/L)

  21. phosphocalcic biologic parameters

    Time frame: Month 0 and Month 12

    phosphorus (mmol/L)

  22. phosphocalcic biologic parameters

    Time frame: Month 0 and Month 12

    proteinemia (g/L)

  23. phosphocalcic biologic parameters

    Time frame: Month 0 and Month 12

    Vitamin D (nmol/L)

  24. phosphocalcic biologic parameters

    Time frame: Month 0 and Month 12

    1-25 OH vitamin D (pmol/L)

  25. phosphocalcic biologic parameters

    Time frame: Month 0 and Month 12

    PTH (ng/L)

  26. phosphocalcic biologic parameters

    Time frame: Month 0 and Month 12

    alkaline bone phosphatases (U/L)

  27. phosphocalcic biologic parameters

    Time frame: Month 0 and Month 12

    CTX (pg/ml)crosslaps

  28. phosphocalcic biologic parameters

    Time frame: Month 0 and Month 12

    osteocalcin (µg/L)

  29. phosphocalcic biologic parameters

    Time frame: Month 0 and Month 12

    ferritin (µg/L)

  30. phosphocalcic biologic parameters

    Time frame: Month 0 and Month 12

    blood count formula : leucocytes (giga/L), erythrocytes (tera/L), hemoglobin (g/L), hematocrit (%), platelets (giga/L)

  31. phosphocalcic biologic parameters

    Time frame: Month 0 and Month 12

    calciuria (mmol/L)

  32. phosphocalcic biologic parameters

    Time frame: 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).

  33. ration lean mass / fat mass

    Time frame: Month 0

    Dual-energy X-ray absorptiometry (DXA)

  34. ration lean mass / fat mass

    Time frame: Month 12

    Dual-energy X-ray absorptiometry (DXA)

  35. Respiratory Functional Exploration

    Time frame: Month 0

  36. Respiratory Functional Exploration

    Time frame: Month 12

  37. Thickness intima / media

    Time frame: Month 0

    echography

  38. Parameters of the connected watch : number of steps

    Time frame: Month 0 and Month 6 and Month 12

    data recovery of the connected watch

  39. Parameters of the connected watch : distance traveled

    Time frame: Month 0 and Month 6 and Month 12

    data recovery of the connected watch

  40. Parameters of the connected watch : calories consumption

    Time frame: Month 0 and Month 6 and Month 12

    data recovery of the connected watch

  41. Ratio thickness intima / media

    Time frame: Month 12

    echography

  42. Bone mineral density

    Time frame: Month 0

    Dual-energy X-ray absorptiometry (DXA)

  43. Bone mineral density

    Time frame: Month 12

    Dual-energy X-ray absorptiometry (DXA)

  44. Number of new fractures

    Time frame: Month 1

  45. Number of new fractures

    Time frame: Month 3

  46. Number of new fractures

    Time frame: Month 6

  47. Number of new fractures

    Time frame: Month 9

  48. Number of new fractures

    Time frame: Month 12

  49. Quality of life questionnaire : PedsQL

    Time frame: 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)

  50. Quality of life questionnaire : PedsQL

    Time frame: 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)

  51. Quality of life questionnaire : PedsQL

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: MOVE-OI

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 8, 2019
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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