RECRUITING

Marfan Syndrome Moderate Exercise Trial II

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Clinical Trial On The Effects Of Moderate Physical Activity On Health And Well-Being In Adolescents And Young Adults With Marfan Syndrome

Quick Facts

Study Start:2023-09-01
Study Completion:2027-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05809323

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 25 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female patients diagnosed with Marfan syndrome (defined by Ghent criteria and either a pathogenic variant in FBN1 or ectopia lentis)
  2. * Age 10-25 years at enrollment
  1. 1. History of aortic surgery
  2. 2. History of spinal surgery with implanted materials that may negatively impact MRI safety or imaging quality.
  3. 3. Diagnosis of major congenital heart disease (ASD, VSD, bicuspid aortic valve, and mitral valve prolapse will not qualify as exclusion criteria)
  4. 4. Condition limiting the ability to perform moderate exercise.
  5. 5. Major concurrent diagnosis that may confound the interpretation of the effect of the proposed intervention on the proposed outcome measures.
  6. 6. Aortic dilation meeting threshold for prophylactic aortic surgical intervention (\>/= 4.5 cm in diameter)

Contacts and Locations

Study Contact

Shaine A Morris, MD, MPH
CONTACT
832-826-5692
shainem@bcm.edu
Jennifer Bogardus, PT, MPT, PhD
CONTACT
713-794-2070
jennifer.bogardus@utah.edu

Principal Investigator

Shaine A Morris, MD, MPH
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine

Study Locations (Sites)

Texas Children's Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

  • Shaine A Morris, MD, MPH, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-01
Study Completion Date2027-07-01

Study Record Updates

Study Start Date2023-09-01
Study Completion Date2027-07-01

Terms related to this study

Keywords Provided by Researchers

  • Cardiovascular
  • Moderate Exercise
  • Physical Therapy

Additional Relevant MeSH Terms

  • Marfan Syndrome