Adapted Physical Activity Program (APA) for Effort Rehabilitation of Children and Teenagers With Marfan Syndrome
M&M's
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.
1 other identifier
interventional
30
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2023
CompletedStudy Start
First participant enrolled
April 24, 2023
CompletedFirst Posted
Study publicly available on registry
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
March 3, 2026
March 1, 2026
4.9 years
March 31, 2023
March 2, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Measurement of maximum endurance
maximum oxygen consumption (VO2 peak) during a cardiopulmonary exercise test will be measured
At baseline
Measurement of maximum endurance
maximum oxygen consumption (VO2 peak) during a cardiopulmonary exercise test will be measured
Up to 6 month
Study Arms (1)
6 month adapted physical activity
EXPERIMENTALThe 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.
Interventions
The Adaptated Physical Activity program will consist of a Personalized Training Program
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Toulouse
Toulouse, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas EDOUARD, MD
University Hospital, Toulouse
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2023
First Posted
May 1, 2023
Study Start
April 24, 2023
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
October 1, 2028
Last Updated
March 3, 2026
Record last verified: 2026-03