Survey on Physical Activity and Qualify of Life in Fibromuscular Dysplasia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Fibromuscular Dysplasia of Arteries, Fibromuscular Dysplasia, Spontaneous Coronary Artery Dissection. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
National Survey of Physical Activity Restrictions and Quality of Life Among Patients With Fibromuscular Dysplasia
Overview
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.
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.
Primary outcome measures
- Clinician-Recommended Physical Activity Restrictions [Time frame: Baseline]
Secondary outcome measures (3)
- Self-Reported Change in Physical Activity Following Diagnosis [Time frame: Baseline]
- Emotional Impact of Physical Activity Recommendations [Time frame: Baseline]
- Physical Impact of Activity Recommendations [Time frame: Baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Vanderbilt University Medical Center — Nashville
Identifiers
NCT: NCT07529691 · 251831