NCT05927389

Brief Summary

This research study aims to evaluate the effect of a 6-month adapted physical activity program (APA) on the endurance capacities (evaluated as the maximum oxygen consumption \[VO2 peak\]) of children and adolescents with Osteogenesis Imperfecta.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress92%
Feb 2024Jul 2026

First Submitted

Initial submission to the registry

June 13, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

February 26, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2026

Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

2.4 years

First QC Date

June 13, 2023

Last Update Submit

February 27, 2024

Conditions

Osteogenesis Imperfecta

Keywords

Osteogenesis ImperfectaChildrenAdolescentsMaximum oxygen consumptionAdapted physical activityEffort rehabilitation

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline maximum endurance capacity at 6 months

    Maximum oxygen consumption (VO2 peak) during an exercise test will be measured

    Change from Baseline to 6 months

Secondary Outcomes (3)

  • Change from baseline quality of life questionnaire score at 6 months

    Change from Baseline to 6 months

  • Change from baseline number of steps at 6 months

    Change from Baseline to 6 months

  • Change from baseline Weight at 6 months

    Change from Baseline to 6 months

Study Arms (1)

Experimental group: 6 months APA program

EXPERIMENTAL

The various assessments will be carried out during 2 visits at 6 months interval as part of the usual follow-up at the "Constitutional Bone Diseases" unit at the Toulouse University Hospital. The APA program built from the initial assessment will be returned to the child and his family during a videoconference. In addition, a regular reassessment and adjustment of this program will be made every 15 days during phone calls by the APA coach.

Other: Adapted Physical Activity program

Interventions

Adapted Physical Activity programOTHER

The Adaptated Physical Activity program consists of a Personalized Training Program adapted to each patient's condition and capacities

Experimental group: 6 months APA program

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosed Osteogenesis Imperfecta
  • Informed and written consent signed by at least one of the two holders of parental authority
  • Patient affiliated to a social security scheme or equivalent

You may not qualify if:

  • Non-walking children (unable to perform the effort test)
  • Pregnant or breastfeeding
  • Participation in other interventional research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Montpellier Hôpital Arnaud de Villeneuve

Montpellier, France

NOT YET RECRUITING

CHU Toulouse

Toulouse, France

RECRUITING

Related Publications (5)

  • Sillence DO, Senn A, Danks DM. Genetic heterogeneity in osteogenesis imperfecta. J Med Genet. 1979 Apr;16(2):101-16. doi: 10.1136/jmg.16.2.101.

    PMID: 458828BACKGROUND

  • Rossi V, Lee B, Marom R. Osteogenesis imperfecta: advancements in genetics and treatment. Curr Opin Pediatr. 2019 Dec;31(6):708-715. doi: 10.1097/MOP.0000000000000813.

    PMID: 31693577BACKGROUND

  • Monti E, Mottes M, Fraschini P, Brunelli P, Forlino A, Venturi G, Doro F, Perlini S, Cavarzere P, Antoniazzi F. Current and emerging treatments for the management of osteogenesis imperfecta. Ther Clin Risk Manag. 2010 Sep 7;6:367-81. doi: 10.2147/tcrm.s5932.

    PMID: 20856683BACKGROUND

  • Arponen H, Waltimo-Siren J, Valta H, Makitie O. Fatigue and disturbances of sleep in patients with osteogenesis imperfecta - a cross-sectional questionnaire study. BMC Musculoskelet Disord. 2018 Jan 8;19(1):3. doi: 10.1186/s12891-017-1922-5.

    PMID: 29310646BACKGROUND

  • Harsevoort AGJ, Gooijer K, van Dijk FS, van der Grijn DAFM, Franken AAM, Dommisse AMV, Janus GJM. Fatigue in adults with Osteogenesis Imperfecta. BMC Musculoskelet Disord. 2020 Jan 3;21(1):6. doi: 10.1186/s12891-019-3000-7.

    PMID: 31900144BACKGROUND

MeSH Terms

Conditions

Osteogenesis Imperfecta

Condition Hierarchy (Ancestors)

OsteochondrodysplasiasBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCollagen DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Thomas EDOUARD, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas EDOUARD, MD

CONTACT

05 61 77 61 10edouard.t@chu-toulouse.fr

Marjolaine WILLEMS, MD

CONTACT

m-willems@chu-montpellier.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2023

First Posted

July 3, 2023

Study Start

February 26, 2024

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

July 15, 2026

Last Updated

February 29, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)