Adapted Physical Activity Program (APA) for Effort Rehabilitation of Children and Teenagers With Marfan Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Adapted Physical Activity program.
- Who it may be relevant to
- Registry conditions: Marfan Syndrome. Basic parameters: 7 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Marfan&Moves (M&M's) : an Adapted Physical Activity Program (APA) for Effort Rehabilitation of Children and Teenagers With Marfan Syndrome: an Interventional, Prospective, Monocentric Study.
Overview
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 \[VO2 peak\] on a cardiopulmonary exercise test) of children and adolescents with Marfan syndrome or related.
Detailed description
Marfan syndrome (MFS) is characterized by the association of multisystem damage related to connective tissue fragility. The risk of aortic dissection has diverted attention from significant musculoskeletal damage despite commonly reported extreme fatigue and pain with impact on the patient's quality of life. In a recent study (Marfanpower, NCT03236571), investigators have observed reduced endurance capacities in children and teenagers with MFS (average VO2 peak at 60% of expected), which were significantly increased by an intensive rehabilitation program. Based on this experience, investigators aim to evaluate the effect of a physical activity program adapted to the daily life of the young patients on their endurance capacities and their quality of life. This program will be set up by an adapted physical activity (APA) coach after a complete assessment, including a cardiopulmonary exercise test with VO2 peak measurement, which will be carried out in the Reference Centre for Marfan syndrome at the Toulouse University Hospital. 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. Investigators hypothesize that the implementation of a physical activity program adapted to the daily life and interests of the child with MFS will efficiently improve endurance, prevent deconditioning and promote long term benefits.
Interventions
- Other Adapted Physical Activity program
The Adaptated Physical Activity program will consist of a Personalized Training Program
Primary outcome measures
- Measurement of maximum endurance [Time frame: At baseline]
- Measurement of maximum endurance [Time frame: Up to 6 month]
Eligibility criteria
Inclusion criteria
- Genetically confirmed Marfan syndrome or related syndrome
- Girl or boy aged 7 to 17
- 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
- Cardiac contraindications to the APA program:
- Severe aortic dilation (aortic diameter > 45 mm)
- and/or left ventricular failure (left ventricular ejection fraction <45%)
- and/or severe mitral leakage ≥ grade 3
- Pregnancy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
France · 1 center
- CHU Toulouse — Toulouse
Identifiers
NCT: NCT05838235 · RC31/22/0206