Health TrialsbyHealthPanel

Marfan Syndrome Moderate Exercise Trial II

ConditionMarfan Syndrome
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-25
SponsorBaylor College of Medicine

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

History of aortic surgery

History of spinal surgery with implanted materials that may negatively impact MRI safety or imaging quality.

Diagnosis of major congenital heart disease (ASD, VSD, bicuspid aortic valve, and mitral valve prolapse will not qualify as exclusion criteria)

Condition limiting the ability to perform moderate exercise.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise Intervention Group

    Other intervention

    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

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Exercise Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupOther 1 intervention

Trial outcomes

Primary outcomes

1

Maximum VO2

Maximum VO2 in ml/kg/minute will be collected via Exercise Stress Test. Range 30-85, higher is better.

Time frame
4 Months

Secondary outcomes

1

Mean systolic blood pressure

mmHg, range 20-200, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile

Time frame
4 Months
2

Mean diastolic blood pressure

mmHg, range 20-150, both low and high are abnormal, goal is age, sex and height-based, goal 10-50 percentile

Time frame
4 Months
3

Mean pulse pressure

mmHg, systolic blood pressure minus diastolic blood pressure, range 30-70 mmHg, goal is normal range for age and sex

Time frame
4 Months
4

Weight

kg, range 50-300kg, lower is better, excluding underweight patients

Time frame
4 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Baylor College of Medicine

Lead sponsor

Southern Star Research

Collaborator

Source ClinicalTrials.gov
Apply now