Adapted physical activity program to improve endurance in children and teens with Marfan syndrome
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 project will try a 6‑month tailored exercise program to see if it improves endurance (VO2 peak) and quality of life in children and teenagers with Marfan syndrome.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 7 Years to 17 Years |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 1 site (Toulouse) |
| Trial ID | NCT05838235 on ClinicalTrials.gov |
What this trial studies
Marfan syndrome causes connective tissue fragility that often leads to musculoskeletal problems, marked fatigue, and reduced endurance in young patients. This interventional program enrolls genetically confirmed participants aged 7–17 and uses a baseline cardiopulmonary exercise test (CPET) with VO2 peak measurement at the Reference Centre for Marfan syndrome in Toulouse to tailor a 6‑month adapted physical activity (APA) plan. An APA coach designs activities matched to daily life and interests and provides ongoing support to promote adherence and prevent deconditioning. The primary outcome is change in VO2 peak after six months, with secondary assessments of fatigue and quality of life.
Who should consider this trial
Good fit: Ideal candidates are children and teenagers aged 7–17 with genetically confirmed Marfan syndrome who have parental informed consent, are affiliated to a social security scheme or equivalent, and do not have the trial's cardiac contraindications.
Not a fit: Patients with severe cardiac involvement (aortic diameter >45 mm, left ventricular ejection fraction <45%, or severe mitral regurgitation ≥ grade 3), pregnant patients, or those unable to participate in the activity program are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, the program could increase endurance, reduce fatigue, and improve daily functioning and quality of life for children and adolescents with Marfan syndrome.
How similar studies have performed: A prior study (Marfanpower, NCT03236571) found greatly reduced VO2 peak in young people with Marfan syndrome and showed that an intensive rehabilitation program significantly increased endurance, so this adapted program builds on promising earlier results.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toulouse
- CHU Toulouse — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Thomas EDOUARD, MD — University Hospital, Toulouse
- Study coordinator: Thomas EDOUARD, MD
- Email: edouard.t@chu-toulouse.fr
- Phone: 05 34 54 91 95
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.