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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-18
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Non-walking children (unable to perform the effort test)

Pregnant or breastfeeding

Participation in other interventional research

Trial design

Design model

Single group

Treatments tested in this trial

  • Adapted Physical Activity program

    Other intervention

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Experimental group: 6 months APA programExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline maximum endurance capacity at 6 months

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

Time frame
Change from Baseline to 6 months

Secondary outcomes

1

Change from baseline quality of life questionnaire score at 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

Time frame
Change from Baseline to 6 months
2

Change from baseline number of steps at 6 months

6-minute walk test (6MWT) assessed by connected watch

Time frame
Change from Baseline to 6 months
3

Change from baseline Weight at 6 months

Body Mass Index

Time frame
Change from Baseline to 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.