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Behavioural Intervention

Exercise for Marfan Syndrome

N/A

Recruiting

Led By Shaine A Morris, MD, MPH

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 10-25 years at enrollment

Male and female patients diagnosed with Marfan syndrome (defined by Ghent criteria and either a pathogenic variant in FBN1 or ectopia lentis)

Must not have

History of aortic surgery

Aortic dilation meeting threshold for prophylactic aortic surgical intervention (>/= 4.5 cm in diameter)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 2 weeks for 4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will study the effects of exercise in people with Marfan or Loeys-Dietz Syndrome, which affect the heart, bones, ligaments, and eyes. Exercise may have beneficial effects like improving strength, joint pain, and mood.

Who is the study for?

This trial is for young individuals aged 10-25 with Marfan syndrome, which affects the body's connective tissue. Participants must meet specific diagnostic criteria and cannot have had aortic or spinal surgery, major heart defects (except some conditions like mitral valve prolapse), conditions that limit moderate exercise, or an aorta wider than 4.5 cm.

What is being tested?

The study examines how safe and effective moderated dynamic exercise is for adolescents and young adults with Marfan Syndrome. It compares an exercise intervention group to a control group that does not receive this intervention.

What are the potential side effects?

While the trial primarily focuses on safety and effectiveness of moderate exercise in patients with Marfan Syndrome, potential side effects may include increased joint pain or cardiovascular stress due to physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 10 and 25 years old.

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I have been diagnosed with Marfan syndrome.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery on my aorta.

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My aorta is enlarged to 4.5 cm or more, needing surgery.

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I have had spinal surgery with implants that might affect MRI scans.

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I cannot do moderate exercise due to my condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 2 weeks for 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 2 weeks for 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 weeks for 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum VO2

Secondary study objectives

Aortic Root Distensibility

Aortic Root β-Stiffness index

Aortic pulse wave velocity from MRI

+24 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Exercise Intervention GroupExperimental Treatment1 Intervention

Group of up to 50 patients will randomly allocated into an experimental group at a 4:1 ratio intervention to controls. The experimental group will receive all of the preliminary outcome measure testing (cardiovascular, musculoskeletal, and psychological screening) in addition to exercise intervention education, demonstration, and follow up to ensure compliance and safety.

Group II: Control GroupExperimental Treatment1 Intervention

Control group will be randomly allocated at a 4:1 ratio, intervention to controls.. The control group will receive all of the preliminary outcome measure testing (cardiovascular, musculoskeletal, and psychological screening) and will be instructed to continue with baseline physical activities. They will be asked to return for a reassessment of all baseline procedures (cardiovascular, musculoskeletal, and psychological screening).

0 / 6Eligibility criteria met