Recruiting

Moderate Exercise

Sponsor:

Baylor College of Medicine

Code:

NCT05809323

Conditions

Marfan Syndrome

Eligibility Criteria

Sex: All

Age: 10 - 25

Healthy Volunteers: Not accepted

Interventions

Exercise Intervention Group

Control Group

Study Details

Brief 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.

Conditions

Marfan Syndrome

Study ID

NCT05809323

Start date

Sep 1, 2023

Status verified date

Aug, 2023

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 25

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

1. History of aortic surgery
2. History of spinal surgery with implanted materials that may negatively impact MRI safety or imaging quality.
3. Diagnosis of major congenital heart disease (ASD, VSD, bicuspid aortic valve, and mitral valve prolapse will not qualify as exclusion criteria)
4. Condition limiting the ability to perform moderate exercise.
5. Major concurrent diagnosis that may confound the interpretation of the effect of the proposed intervention on the proposed outcome measures.
6. Aortic dilation meeting threshold for prophylactic aortic surgical intervention (>/= 4.5 cm in diameter)

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

Interventions

Exercise Intervention Group

Patients will be educated on methods of self-evaluating exertion and cardiovascular effort by assessing respiratory rate and perceived exertion. Next, patients will be given options for cardiovascular activities and complete at a moderate level of activity for a minimum of 150 minutes per week. Patients will perform a combination of exercises under the supervision of a physical therapist until a mod intensity level is reached and sustained. Patients will be taught to use the activity tracker to record their heart rate, activity, and PES. Patients will have a phone call every week to assess status, answer questions, and provide guidance on progressing intensity or duration of exercise. At the end of 12 weeks all patients will return for re-assessment.

Control Group

Patients in the control group will be instructed to continue with baseline physical activities over the duration of the study and be given instructions on the use of the activity tracker. At the end of 12 weeks all patients will return for re-assessment.

Primary outcome measure

  • Maximum VO2 [ Time Frame: 4 Months ]

Central Contacts and Locations

Central contacts

Shaine A Morris, MD, MPH

832-826-5692shainem@bcm.edu

Jennifer Bogardus, PT, MPT, PhD

713-794-2070jennifer.bogardus@utah.edu

Locations

Texas Children's Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Shaine A Morris, MD MPH

832-826-5682shainem@bcm.edu

Jennifer Bogardus, PT, MPT, PhD

713-794-2070jbogardus@twu.edu

More Information

Sponsor

Baylor College of Medicine

Last update posted

Jan 24, 2024

Last verified

Aug, 2023

Keywords

  • Cardiovascular
  • Moderate Exercise
  • Physical Therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Baylor College of Medicine on 2024-01-24.