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CompletedNCT04119388MOVE-OIUpdated Sep 10, 2025

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

An interventional study of Adapted sports practices in Osteogenesis Imperfecta, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-09-10.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
6 Years to 17 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Osteogenesis Imperfecta

Keywords

  • osteogenesis imperfecta
  • Adapted sport
  • Quality of life
03

In context

Osteogenesis Imperfecta

84 studies on the registry are indexed under Osteogenesis Imperfecta; 20 are open to participants now.

This study's enrollment of 30 is close to the median of 28 across 60 interventional studies indexed under Osteogenesis Imperfecta.

Browse Osteogenesis Imperfecta studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Browse Hospices Civils de Lyon studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Medical and surgical to adapted physical activity.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

Interventions

  • OtherAdapted sports practices

    Adapted sports practices for 30 minutes twice a week

06

What researchers measure

Primary outcomes

  1. 6 minutes walk test

    Distance traveled (in meters) in 6 minutes

    Time frame: Month 0

  2. 6 minutes walk test

    Distance traveled (in meters) in 6 minutes

    Time frame: Month 6

  3. 6 minutes walk test

    Distance traveled (in meters) in 6 minutes

    Time frame: Month 12

Secondary outcomes

  1. Weight

    weight in kilograms will be measured with a scale

    Time frame: Month 0

  2. Weight

    weight in kilograms will be measured with a scale

    Time frame: Month 6

  3. Weight

    weight in kilograms will be measured with a scale

    Time frame: Month 12

  4. Height

    Size in meter measured with a meter

    Time frame: Month 0

  5. Height

    Size in meter measured with a meter

    Time frame: Month 6

  6. Height

    Size in meter measured with a meter

    Time frame: Month 12

  7. body mass index

    calculated with weight and height

    Time frame: Month 0

  8. body mass index

    calculated with weight and height

    Time frame: Month 6

  9. body mass index

    calculated with weight and height

    Time frame: Month 12

  10. blood pressure

    measurement of blood pressure (cm Hg)

    Time frame: Month 0

  11. blood pressure

    measurement of blood pressure (cm Hg)

    Time frame: Month 6

  12. blood pressure

    measurement of blood pressure (cm Hg)

    Time frame: Month 12

  13. phosphocalcic biologic parameters

    Ionosodium (mmol/L)

    Time frame: Month 0 and Month 12

  14. phosphocalcic biologic parameters

    potassium (mmol/L)

    Time frame: Month 0 and Month 12

  15. phosphocalcic biologic parameters

    calcium (mmol/L)

    Time frame: Month 0 and Month 12

  16. phosphocalcic biologic parameters

    chlore (mmol/L)

    Time frame: Month 0 and Month 12

  17. phosphocalcic biologic parameters

    bicarbonates (mmol/L)

    Time frame: Month 0 and Month 12

  18. phosphocalcic biologic parameters

    glucose (mmol/L)

    Time frame: Month 0 and Month 12

  19. phosphocalcic biologic parameters

    urea (mmol/L)

    Time frame: Month 0 and Month 12

  20. phosphocalcic biologic parameters

    creatinemia (mmol/L)

    Time frame: Month 0 and Month 12

  21. phosphocalcic biologic parameters

    phosphorus (mmol/L)

    Time frame: Month 0 and Month 12

  22. phosphocalcic biologic parameters

    proteinemia (g/L)

    Time frame: Month 0 and Month 12

  23. phosphocalcic biologic parameters

    Vitamin D (nmol/L)

    Time frame: Month 0 and Month 12

  24. phosphocalcic biologic parameters

    1-25 OH vitamin D (pmol/L)

    Time frame: Month 0 and Month 12

  25. phosphocalcic biologic parameters

    PTH (ng/L)

    Time frame: Month 0 and Month 12

  26. phosphocalcic biologic parameters

    alkaline bone phosphatases (U/L)

    Time frame: Month 0 and Month 12

  27. phosphocalcic biologic parameters

    CTX (pg/ml)crosslaps

    Time frame: Month 0 and Month 12

  28. phosphocalcic biologic parameters

    osteocalcin (µg/L)

    Time frame: Month 0 and Month 12

  29. phosphocalcic biologic parameters

    ferritin (µg/L)

    Time frame: Month 0 and Month 12

  30. phosphocalcic biologic parameters

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

    Time frame: Month 0 and Month 12

  31. phosphocalcic biologic parameters

    calciuria (mmol/L)

    Time frame: Month 0 and Month 12

  32. 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).

    Time frame: Month 0 and Month 12

  33. ration lean mass / fat mass

    Dual-energy X-ray absorptiometry (DXA)

    Time frame: Month 0

  34. ration lean mass / fat mass

    Dual-energy X-ray absorptiometry (DXA)

    Time frame: Month 12

  35. Respiratory Functional Exploration

    Time frame: Month 0

  36. Respiratory Functional Exploration

    Time frame: Month 12

  37. Thickness intima / media

    echography

    Time frame: Month 0

  38. Parameters of the connected watch : number of steps

    data recovery of the connected watch

    Time frame: Month 0 and Month 6 and Month 12

  39. Parameters of the connected watch : distance traveled

    data recovery of the connected watch

    Time frame: Month 0 and Month 6 and Month 12

  40. Parameters of the connected watch : calories consumption

    data recovery of the connected watch

    Time frame: Month 0 and Month 6 and Month 12

  41. Ratio thickness intima / media

    echography

    Time frame: Month 12

  42. Bone mineral density

    Dual-energy X-ray absorptiometry (DXA)

    Time frame: Month 0

  43. Bone mineral density

    Dual-energy X-ray absorptiometry (DXA)

    Time frame: Month 12

  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

    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)

    Time frame: Month 0

  50. 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)

    Time frame: Month 6

  51. 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)

    Time frame: Month 12

07

Study locations

1 site
  • Centre de Référence des Maladies Rénales Rares - Hospices Civils de Lyon - Service de Néphrologie et Rhumatologie Pédiatriques - Hôpital Femme Mère Enfant
    Bron, 69500, France
08

References and documents

Publications

  • Al Arab H, Flammier S, Espitalier M, Bacchetta J, Fouillet-Desjonqueres M. Evaluation of the benefits of adapted physical activity in children and adolescents with osteogenesis imperfecta: the MOVE-OI trial. Orphanet J Rare Dis. 2025 Apr 12;20(1):175. doi: 10.1186/s13023-025-03678-4. PubMed 40221747 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2019 to primary completion in Oct 2022, 35 months.

Of 17 interventional studies with no phase under Osteogenesis Imperfecta, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 35. This study's 35 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 1, 2019
First posted
Oct 8, 2019
StartActual
Nov 4, 2019
Primary completionActual
Oct 14, 2022
CompletionActual
Oct 14, 2022
Last update
Sep 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04119388
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Oct 8, 2019
Start date
Nov 4, 2019
Primary completion
Oct 14, 2022
Completion
Oct 14, 2022
Last update
Sep 10, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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