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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 2 weeks for 4 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 10 and 25 years old.
Select...
I have been diagnosed with Marfan syndrome.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum VO2
Secondary outcome measures
Aortic Root Distensibility
Aortic Root β-Stiffness index
Aortic pulse wave velocity from MRI
+24 moreTrial 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).
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Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,362 Total Patients Enrolled
1 Trials studying Marfan Syndrome
23 Patients Enrolled for Marfan Syndrome
Southern Star Research Pty Ltd.Industry Sponsor
13 Previous Clinical Trials
556 Total Patients Enrolled
Shaine A Morris, MD, MPHPrincipal InvestigatorBaylor College of Medicine
2 Previous Clinical Trials
52 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 10 and 25 years old.I have had surgery on my aorta.I do not have any major health issues that could affect the study's results.My aorta is enlarged to 4.5 cm or more, needing surgery.I have a major congenital heart disease, but not ASD, VSD, bicuspid aortic valve, or mitral valve prolapse.I have had spinal surgery with implants that might affect MRI scans.I cannot do moderate exercise due to my condition.I have been diagnosed with Marfan syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Control Group
- Group 2: Exercise Intervention Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this clinical investigation accessible to individuals below the age of sixty-five?
"The age limit for this medical study ranges from 10 years to 25 years, as stipulated in the participant eligibility criteria."
Answered by AI
Are there any qualifying criteria that would permit me to join this research?
"Patients who have marfan syndrome and are aged between 10 to 25 years old may qualify for this research trial, which is currently looking to recruit around 50 people."
Answered by AI
Are there any recruitment opportunities available for this experiment?
"According to clinicaltrials.gov, registration for this study has been closed since March 30th of 2023. The initial post date was July 1st, 2023. Fortunately, there are 1443 other studies still recruiting participants at the present moment."
Answered by AI
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