Actively Recruiting
Clinical Trial On The Effects Of Moderate Physical Activity On Health And Well-Being In Adolescents And Young Adults With Marfan Syndrome
Led by Baylor College of Medicine · Updated on 2024-01-24
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
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 connective tissue disorder that affects the heart, bones, ligaments, and eyes, with a high risk of aortic dissection. Most patients are advised to avoid certain physical activities due to concerns about safety, leading many to become sedentary. This inactivity can cause weakness, joint pain, reduced endurance, and depressive symptoms. Research in rodents suggests moderate dynamic exercise might protect heart and aorta structures, prompting this trial to assess such exercise effects in adolescents and young adults with MFS. The study randomly assigns up to 50 patients aged 10 to 25 years with MFS to either a moderate dynamic exercise intervention group or a control group, using a 4:1 ratio. The exercise group receives education, supervised practice, and weekly phone follow-ups to reach and maintain moderate intensity exercise for at least 150 minutes per week over 12 weeks. The control group continues their usual physical activities. Both groups undergo cardiovascular, musculoskeletal, and psychological testing before and after the intervention period. Participants will complete baseline assessments including maximal oxygen uptake, blood pressure, aortic stiffness, heart function by MRI, physical therapy evaluation, and mental health questionnaires. They will use activity trackers to monitor exercise and have regular follow-ups to ensure safety and adherence. The primary outcome is maximum VO2 after 4 months, with secondary outcomes measuring blood pressure, heart strain, aortic dimensions, quality of life, and anxiety or depression symptoms. The study aims to evaluate whether moderate exercise improves health without harming the aorta.
CONDITIONS
Brief Title
Marfan Syndrome Moderate Exercise Trial II
Who Can Participate
Eligibility Criteria
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
You will not qualify if you...
- History of aortic surgery
- History of spinal surgery with implanted materials that may negatively impact MRI safety or imaging quality
- Diagnosis of major congenital heart disease (except ASD, VSD, bicuspid aortic valve, and mitral valve prolapse)
- Condition limiting the ability to perform moderate exercise
- Major concurrent diagnosis that may confound interpretation of intervention effects
- Aortic dilation meeting threshold for prophylactic aortic surgical intervention (≥ 4.5 cm in diameter)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants in the exercise group receive education on moderate physical activity, learn to self-monitor exertion, and perform moderate exercise for at least 150 minutes per week with weekly phone support. Control participants continue their baseline physical activities. Both groups use activity trackers during this period.
Weekly phone calls and 1 in-person re-assessment visit at the end of 12 weeks
Duration - 1 visit at 12 weeks post-treatment
Participants return for re-assessment of cardiovascular, musculoskeletal, and psychological outcomes to evaluate the effects of the intervention or control condition.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Shaine A Morris, MD, MPH
J
Jennifer Bogardus, PT, MPT, PhD
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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