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

NCT07419386 | Not Yet Recruiting

• 1 other identifier: ActMarf
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Marfan Syndrome

Keywords

Marfan syndrome; Motor activity; Exercise; Kinesiophobia; Fatigue; Pain; Self efficacy

Outcome Measures

Primary Outcomes (1)

• Measurement of physical activity level

  This variable will be assessed using the validated Spanish version of the International Physical Activity Questionnaire-Short Form (IPAQ-SF). The questionnaire records the frequency (days/week) and duration (minutes/day) of vigorous-intensity activities, moderate-intensity activities, and walking performed during the previous 7 days. Total physical activity will be expressed in MET-minutes per week, calculated according to the official IPAQ scoring protocol (8.0 METs for vigorous activity, 4.0 METs for moderate activity, and 3.3 METs for walking). In addition, physical activity level will be categorized as low, moderate, or high, based on the criteria established by the instrument.

  Screening visit.

Secondary Outcomes (8)

• Measurement of kinesiophobia (fear of movement or physical exertion)

  Screening visit

• Measurement of physical activity self-efficacy

  Screening visit

• Measurement of perceived fatigue

  Screening visit

• Measurement of musculoskeletal pain

  Screening visit

• Measurement of history of cardiovascular surgery

  Screening visit

Other Outcomes (6)

• Measurement of age

  Screening visit

• Measurement of gender

  Screening visit

• Measurement of body mass index

  Screening visit

Study Arms (1)

Observational group

Adults with a diagnosis of Marfan syndrome

Other: Adults with Marfan syndrome

Interventions

Adults with Marfan syndrome OTHER

Assessment of psychosocial and clinical factors potentially associated with engagement in physical activity, including kinesiophobia, physical activity self-efficacy, perceived fatigue, musculoskeletal pain, and cardiovascular clinical factors (aortic history and treatment)

Observational group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with Marfan syndrome

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Oviedo: lead

Study Sites (1)

Universidad de Oviedo

Oviedo, Principality of Asturias, 33006, Spain

Location

MeSH Terms

Conditions

Marfan Syndrome; Motor Activity; Kinesiophobia; Fatigue; Pain

Interventions

Fibrillins

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Behavior; Phobic Disorders; Anxiety Disorders; Mental Disorders; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Extracellular Matrix Proteins; Scleroproteins

Central Study Contacts

Rubén Cuesta-Barriuso, PhD

CONTACT

0034 985103386; cuestaruben@uniovi.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 19, 2026
• Study Start: February 22, 2026
• Primary Completion: April 13, 2026
• Study Completion (Estimated): May 26, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

ES (1)