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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05838235
Other study ID # RC31/22/0206
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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Completed NCT04776668 - Living With Marfan Syndrome and Your Aorta
Recruiting NCT01949233 - The Oxford Marfan Trial Phase 2
Active, not recruiting NCT01145612 - Atenolol Versus Losartan in the Prevention of Progressive Dilation of the Aorta in Marfan Syndrome Phase 3
Completed NCT00723801 - Effects of Losartan Versus Atenolol on Aortic and Cardiac Muscle Stiffness in Adults With Marfan Syndrome Phase 3
Completed NCT04641325 - Marfan Syndrome Moderate Exercise Pilot N/A
Recruiting NCT06257004 - Genome-wide Epistasis for Cardiovascular Severity in Marfan Study
Completed NCT01322165 - National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Cardiovascular Conditions N/A
Recruiting NCT05700175 - Transcriptomic Study of Adult Population With Marfan Syndrome
Completed NCT00782327 - Randomized, Double-blind Study for the Evaluation of the Effect of Losartan Versus Placebo on Aortic Root Dilatation in Patients With Marfan Syndrome Under Treatment With Beta-blockers Phase 3
Recruiting NCT02148900 - Development of a Blood Test for Marfan Syndrome N/A
Active, not recruiting NCT05980104 - Single-Session "Empowered Relief" Class for Marfan Syndrome and Related Conditions N/A
Recruiting NCT02050113 - Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices N/A
Completed NCT00001641 - Study of Heritable Connective Tissue Disorders N/A
Completed NCT01715207 - Comparison Study of the Effect of Aliskiren Versus Negative Controls on Aortic Stiffness in Patients With Marfan Syndrome Under Treatment With Atenolol Phase 3
Completed NCT05516043 - Safety and Performance of POLYTHESE® Vascular Prosthesis
Recruiting NCT04776681 - Living With Marfans and Your Aorta: Surgical Outcomes Study
Completed NCT03236571 - Cardiorespiratory and Muscular Rehabilitation of Children and Young Adults With Marfan Syndrome. N/A
Recruiting NCT00683124 - Nebivolol Versus Losartan Versus Nebivolol+Losartan Against Aortic Root Dilation in Genotyped Marfan Patients Phase 3