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

March 2, 2026 updated by: University Hospital, Toulouse

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

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

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

Accepts Healthy Volunteers

No

Description

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

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: 6 month adapted physical activity

The various assessments will be carried out during 2 visits at 6 months interval as part of the usual follow-up at the Toulouse University Hospital. Standard cardiopulmonary exercise test assessment will be coupled with an assessment by an APA coach on the same day.

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 will consist of a Personalized Training Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of maximum endurance
Time Frame: At baseline
maximum oxygen consumption (VO2 peak) during a cardiopulmonary exercise test will be measured
At baseline
Measurement of maximum endurance
Time Frame: Up to 6 month
maximum oxygen consumption (VO2 peak) during a cardiopulmonary exercise test will be measured
Up to 6 month

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, University Hospital, Toulouse

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)

April 24, 2023

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

April 20, 2023

First Posted (Actual)

May 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/22/0206

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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