Adapted Physical Activity Program (APA) for Effort Rehabilitation of Children and Teenagers With Osteogenesis Imperfecta (BONeMOVE)

February 27, 2024 updated by: University Hospital, Toulouse

BONeMOVE : an Adapted Physical Activity Program (APA) for Effort Rehabilitation of Children and Teenagers With Osteogenesis Imperfecta: an Interventional, Prospective, Regional, Bicentric Study.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Osteogenesis Imperfecta (OI) is a rare genetic disease characterised mainly by bone fragility, decreased bone mass and a susceptibility to fractures of varying severity. Different forms have been described according to the severity of the bone manifestations. Although it is a genetically heterogeneous disease, approximately 90% of OI patients have a mutation in the gene encoding gene encoding type 1 collagen, a major component of the extracellular matrix.

Chronic fatigue and decreased physical endurance are almost constant complaints of patients with OI (more than 95% according to some studies), which impacts the activities of daily living and quality of life of these patients. The causes of this decrease in endurance are multifactorial involving prolonged immobilisation secondary to fractures, chronic osteoarticular pain, but also primary muscle damage.

Mechanography studies carried out in children with OI have shown a significant deficit in muscle function in terms of both strength and power.

In healthy adults, physical inactivity is an important predictor of feeling of tired. In addition, in some chronic diseases (such as multiple sclerosis, rheumatoid arthritis or systemic lupus erythematosus), physical activity and training have been shown to be effective in improving muscle strength and functional capacity as well as fatigue and quality of life. In OI, it has been reported that physical activity improves muscle function and bone mass. Patients with OI should therefore benefit from a regular exercise programme taking into account their risk of fracture.

This study aims to evaluate the effect of a life-skills physical activity (LSPA) programme on the endurance capacities and quality of life of children and adolescents with OI.

The VO2 peak evolution will be evaluated after 6 months of program. This is a recognized parameter for the evaluation of endurance and has been validated in children. The hypothesis of this study is that the implementation of a physical activity program adapted to the daily life and interests of the child with OI will efficiently improve endurance, prevent deconditioning and promote long term benefits.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Montpellier, France
        • Not yet recruiting
        • CHU Montpellier Hôpital Arnaud de Villeneuve
        • Contact:
          • Marjolaine WILLEMS, MD
        • Contact:
        • Principal Investigator:
          • Marjolaine WILLEMS
      • Toulouse, France

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group: 6 months APA program

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline maximum endurance capacity at 6 months
Time Frame: Change from Baseline to 6 months
Maximum oxygen consumption (VO2 peak) during an exercise test will be measured
Change from Baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline quality of life questionnaire score at 6 months
Time Frame: Change from Baseline to 6 months
Osteogenesis Imperfecta Specific Quality of Life Questionnaire (OIQoL). Total scores are based on a 0-100 scale, where a high score represents better quality of life
Change from Baseline to 6 months
Change from baseline number of steps at 6 months
Time Frame: Change from Baseline to 6 months
6-minute walk test (6MWT) assessed by connected watch
Change from Baseline to 6 months
Change from baseline Weight at 6 months
Time Frame: Change from Baseline to 6 months
Body Mass Index
Change from Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Investigators

  • Principal Investigator: Thomas EDOUARD, MD, CHU Toulouse

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2024

Primary Completion (Estimated)

July 15, 2026

Study Completion (Estimated)

July 15, 2026

Study Registration Dates

First Submitted

June 13, 2023

First Submitted That Met QC Criteria

June 27, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/23/0248

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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