Moderate exercise program for adolescents and young adults with Marfan syndrome
Clinical Trial On The Effects Of Moderate Physical Activity On Health And Well-Being In Adolescents And Young Adults With Marfan Syndrome
This study is testing whether a moderate exercise program can help teenagers and young adults with Marfan syndrome feel better both physically and mentally.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 10 Years to 25 Years |
| Sex | All |
| Sponsor | Baylor College of Medicine Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05809323 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effects of moderate dynamic exercise on adolescents and young adults diagnosed with Marfan syndrome, a connective tissue disorder that poses risks to cardiovascular health. Participants will be divided into an exercise intervention group and a control group to assess the impact of exercise on their physical and mental well-being. The study aims to address the lack of data on exercise effects in this population, as many are currently advised against physical activity due to concerns about aortic dissection. By evaluating the outcomes of moderate exercise, the trial seeks to provide evidence that could inform future guidelines for physical activity in patients with Marfan syndrome.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 10-25 years diagnosed with Marfan syndrome.
Not a fit: Patients with a history of aortic surgery or significant aortic dilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved physical health and quality of life for patients with Marfan syndrome through safe exercise recommendations.
How similar studies have performed: While there are no controlled studies on dynamic exercise in humans with Marfan syndrome, related research in rodent models has shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: 1. History of aortic surgery 2. History of spinal surgery with implanted materials that may negatively impact MRI safety or imaging quality. 3. Diagnosis of major congenital heart disease (ASD, VSD, bicuspid aortic valve, and mitral valve prolapse will not qualify as exclusion criteria) 4. Condition limiting the ability to perform moderate exercise. 5. Major concurrent diagnosis that may confound the interpretation of the effect of the proposed intervention on the proposed outcome measures. 6. Aortic dilation meeting threshold for prophylactic aortic surgical intervention (\>/= 4.5 cm in diameter)
Where this trial is running
Houston, Texas
- Texas Children's Hospital — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Shaine A Morris, MD, MPH — Baylor College of Medicine
- Study coordinator: Shaine A Morris, MD, MPH
- Email: shainem@bcm.edu
- Phone: 832-826-5692
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.