Survey on Physical Activity and Qualify of Life in Fibromuscular Dysplasia

April 14, 2026 updated by: Amanda Morrison, Vanderbilt University Medical Center

National Survey of Physical Activity Restrictions and Quality of Life Among Patients With Fibromuscular Dysplasia

Fibromuscular dysplasia (FMD) is a disease of the arteries that is not due to plaque build-up or inflammation. While some patients with FMD are health, some may experience heart attacks, strokes, aneurysms or blood vessel dissection/tearing which can be life-threatening. It predominantly impacts women and younger patients. As a result of this diagnosis, many patients are counseled to restrict or avoid certain physical activities out of concern for provoking or worsening vascular complications. There are no guidelines or consensus recommendations regarding appropriate physical activity for patients with FMD. The lack of consensus may lead to confusion for patients and may negatively impact their quality of life. This study will conduct a large, national survey of patients with FMD to assess the type of physical activity restrictions and impact on quality of life and emotional well-being.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Fibromuscular dysplasia (FMD) is a non-atherosclerotic, non-inflammatory disease of medium-sized arteries characterized by intimal and medial hyperplasia. The exact prevalence of FMD is unknown, but it predominantly impacts women and middle-age patients, with a mean age of 52 at the time of diagnosis. The manifestations of FMD are variable and may include spontaneous coronary artery dissection (SCAD) as well as extra-coronary vascular abnormalities (EVAs), such as peripheral artery aneurysms or dissections. Many patients are counseled to restrict or avoid certain physical activities out of concern for provoking or worsening vascular complications.3,4 However, there are no guidelines or consensus recommendations regarding appropriate physical activity for patients with FMD in the available 2018 American Heart Association (AHA) Scientific statement or the 2019 first international consensus document on FMD. Recommendations are formed based on expert opinion, and may vary based on a variety of factors including severity of disease, treating institution, or sex. The lack of consensus may lead to confusion for patients and may negatively impact their quality of life. This survey will be delivered electronically via RedCap to participants who self-identify as having a diagnosis of fibromuscular dysplasia. It will be the first to identify the breadth and content, as well as the impact, of physical activity recommendations provided by healthcare personnel to patients with FMD. Data gathered from this study will encourage the creation of an expert consensus document on recommendations for physical activity by FMD phenotype, which will have implications for patient education and empowerment for those living with FMD. This may also lead to areas of future intervention to mitigate adverse quality of life if identified.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amanda M Morrison, MD
        • Sub-Investigator:
          • Aaron W Aday, MD, MSc

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals with a diagnosis of fibromuscular dysplasia

Description

Inclusion criteria:

  • Participants with a diagnosis of fibromuscular dysplasia
  • Age range = 18-100 years

Exclusion Criteria:

  • Subjects who have an inability to complete the electronic consent form or electronic survey for any reason
  • Subjects who are non-English speaking who cannot read the electronic consent form or electronic survey

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with fibromuscular dysplasia
Patients who identify as having a confirmed diagnosis of fibromuscular dysplasia, or patients at Vanderbilt University Medical Center who have a confirmed diagnosis of fibromuscular dysplasia as determined by their provider.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician-Recommended Physical Activity Restrictions
Time Frame: Baseline
Prevalence and type of clinician-recommended physical activity restrictions among patients diagnosed with fibromuscular dysplasia (FMD), including aerobic, resistance, and activity-specific limitations.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Reported Change in Physical Activity Following Diagnosis
Time Frame: Baseline
Change in physical activity behavior following FMD diagnosis based on patient self-report.
Baseline
Emotional Impact of Physical Activity Recommendations
Time Frame: Baseline
Self-reported anxiety or depression to physical activity recommendations and/or disease-related limitations.
Baseline
Physical Impact of Activity Recommendations
Time Frame: Baseline
Self-reported physical consequences (e.g. weight gain, sedentary lifestyle) associated with modification of activity level following FMD diagnosis.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University Medical Center

Collaborators

Fibromuscular Dysplasia Society of America

Investigators

  • Study Chair: Aaron W Aday, MD, MSc, Vanderbilt University Medical Center

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 Major Dates

Study Start (Actual)

April 14, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

April 6, 2026

First Submitted That Met QC Criteria

April 10, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 251831

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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