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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 25
Healthy Volunteers: f
View:

• 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

Locations
United States
Texas
Texas Children's Hospital
RECRUITING
Houston
Contact Information
Primary
Shaine A Morris, MD, MPH
shainem@bcm.edu
832-826-5692
Backup
Jennifer Bogardus, PT, MPT, PhD
jennifer.bogardus@utah.edu
713-794-2070
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 50
Treatments
Experimental: Exercise Intervention Group
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.
Other: Control Group
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).
Related Therapeutic Areas
Sponsors
Leads: Baylor College of Medicine
Collaborators: Southern Star Research

This content was sourced from clinicaltrials.gov