ClinicalTrials.gov record NCT07419386

Clinical and Psychosocial Factors Associated With Physical Activity Level in Adults With Marfan Syndrome

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 6, 2026

Clinical and Psychosocial Factors Associated With Physical Activity Level in Adults With Marfan Syndrome: A Cross-Sectional Observational Study

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.
Age18 years old and older
SexAll
LocationSpain
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a cross-sectional observational study of adults with Marfan syndrome that uses online questionnaires. It measures physical activity level and several psychosocial and clinical factors (for example, fear of movement, fatigue, pain, self-efficacy, and cardiovascular history). The study will analyze which factors are associated with low physical activity.

What it is studying. The study measures how active adults with Marfan syndrome are and tests whether clinical factors (for example, aortic history or cardiovascular treatment) and psychosocial factors (kinesiophobia/fear of movement, physical activity self-efficacy, perceived fatigue, and musculoskeletal pain) are associated with low physical activity.

What the researchers hope to learn. To describe physical activity levels in adults with Marfan syndrome and identify clinical and psychosocial factors that predict low physical activity.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Background. Marfan syndrome is a genetic connective tissue disorder with cardiovascular and musculoskeletal involvement. Despite clinical advances, many patients exhibit low levels of physical activity, influenced by clinical and psychosocial factors such as fear of exertion, fatigue, or pain. Physical activity behavior in this population remains insufficiently characterized. Objective. To assess the level of physical activity in adults with Marfan syndrome and to identify the main associated clinical and psychosocial factors, in order to determine predictors of low physical activity. Methods. An observational, analytical, cross-sectional study will be conducted. Adults with a diagnosis of Marfan syndrome will be included. The primary outcome will be physical activity level, assessed using the International Physical Activity Questionnaire-Short Form. The main independent variables will include kinesiophobia (Tampa Scale for Kinesiophobia), physical activity self-efficacy, perceived fatigue (Fatigue Severity Scale), musculoskeletal pain (Brief Pain Inventory-Short Form), and cardiovascular clinical factors. Potential confounders will include age, sex, body mass index, time since diagnosis, medical recommendations regarding exercise, and current pain. Descriptive analyses and a multivariable logistic regression model will be performed to identify independent predictors of low physical activity. Expected results. To characterize the level of physical activity in adults with Marfan syndrome and to identify the clinical and psychosocial factors that independently predict low physical activity in this population.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Other
  • Adults with Marfan syndrome

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • Adults (≥18 years).
  • A confirmed diagnosis of Marfan syndrome according to accepted clinical criteria used in routine follow-up.
  • Ability to understand and complete an online questionnaire in Spanish.
  • Access to the internet and an appropriate device to complete the survey.
  • Provision of informed consent to participate in the study.

Exclusion criteria

  • Patients with cognitive impairment or comprehension/literacy difficulties that preclude valid completion of the questionnaires.
  • Who have experienced a major cardiovascular event or undergone recent cardiovascular/aortic surgery that substantially limits physical activity during the most recent reference period (e.g., within the past 3 months).
  • With acute conditions or recent musculoskeletal injuries not attributable to Marfan syndrome that markedly restrict physical activity during the previous 7 days (the reference period of the IPAQ-SF).
  • With incomplete questionnaires for essential variables (IPAQ-SF and/or main predictors)

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Take part by completing a Spanish-language online survey (one cross-sectional visit) that includes the IPAQ‑SF (physical activity over the past 7 days) and questionnaires about fear of movement, exercise self-efficacy, fatigue, pain, plus questions about cardiovascular history and current treatment. Study data are collected at that single time point and include the listed questionnaire responses and recorded cardiovascular clinical factors. Completing all essential questionnaires is required; missing essential responses will make the questionnaire ineligible for analysis.

How the study is structured. A single-time, cross-sectional observational study: participants complete validated questionnaires (including the IPAQ‑SF and scales for kinesiophobia, fatigue, pain, and self-efficacy) online. Collected data will be summarized and analyzed to identify factors linked with low physical activity.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in Spain. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on Marfan syndrome

Clinical trials20 trials listed for Marfan syndromeEvery trial the registry lists for Marfan syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in Marfan syndrome researchLatest monthly update: September 2026. Includes: After open aortic repair. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Feb 22, 2026 (estimated)
Primary completion
Apr 13, 2026 (estimated)
Study completion
May 26, 2026 (estimated)
Target enrollment
118 participants (estimated)
Last updated on registry
Feb 19, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
University of Oviedo
Principal investigator
Ruben Cuesta Barriuso, Principal Investigator
University of Oviedo

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

primary outcome
The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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