Actively Recruiting

Phase Not Applicable
Age: 10Years - 25Years
All Genders
NCT05809323

Marfan Syndrome Moderate Exercise Trial II

Led by Baylor College of Medicine · Updated on 2024-01-24

50

Participants Needed

1

Research Sites

199 weeks

Total Duration

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Sponsors

B

Baylor College of Medicine

Lead Sponsor

S

Southern Star Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

Marfan syndrome (MFS) is a distinctive connective tissue disorder that affects multiple organ systems including the heart, bones, ligaments, and eyes, and is associated with significant risk of aortic dissection. Given limited evidence from in-vitro studies, and theoretical concerns, the majority of patients with MFS are restricted from certain physical activities. The lack of exercise and deconditioning have detrimental effects including increasing weakness, joint pain, decreased endurance, and depressive symptoms. Given the significant paucity of data currently existing on the effects of exercise in humans with MFS, and the recent, optimistic findings in rodent models, this pilot trial was established to assess the effects of moderated dynamic exercise in adolescents and young adults with MFS.

CONDITIONS

Official Title

Marfan Syndrome Moderate Exercise Trial II

Who Can Participate

Age: 10Years - 25Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female patients diagnosed with Marfan syndrome (defined by Ghent criteria and either a pathogenic variant in FBN1 or ectopia lentis)
  • Age 10-25 years at enrollment
Not Eligible

You will not qualify if you...

  • History of aortic surgery
  • History of spinal surgery with implanted materials that may affect MRI safety or quality
  • Diagnosis of major congenital heart disease (other than ASD, VSD, bicuspid aortic valve, or mitral valve prolapse)
  • Condition limiting the ability to perform moderate exercise
  • Major concurrent diagnosis that may affect interpretation of study outcomes
  • Aortic dilation 4.5 cm or larger requiring prophylactic surgery

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Texas Children's Hospital

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

S

Shaine A Morris, MD, MPH

CONTACT

J

Jennifer Bogardus, PT, MPT, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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