Adapted Physical Activity Program (APA) for Effort Rehabilitation of Children and Teenagers With Marfan Syndrome

Marfan Syndrome Clinical Trial

— M&M's  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05838235
• Other study ID #: RC31/22/0206
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: November 2024

Study information

• Verified date: April 2023
• Source: University Hospital, Toulouse
• Contact: Thomas EDOUARD, MD
• Phone: 05 34 54 91 95
• Email: edouard.t[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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] on a cardiopulmonary exercise test) of children and adolescents with Marfan syndrome or related.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: November 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Marfan Syndrome
• Syndrome

Intervention

Other:
• Adapted Physical Activity program
The Adaptated Physical Activity program will consist of a Personalized Training Program

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of maximum endurance	maximum oxygen consumption (VO2 peak) during a cardiopulmonary exercise test will be measured	At baseline
Primary	Measurement of maximum endurance	maximum oxygen consumption (VO2 peak) during a cardiopulmonary exercise test will be measured	Up to 6 month