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NCT Number: NCT07419386

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

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.

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Key information

Conditions

Marfan Syndrome Abnormalities, Multiple Anxiety Disorders Behavior Bone Diseases Bone Diseases, Developmental Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Fatigue Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases Kinesiophobia Mental Disorders Motor Activity Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Phobic Disorders Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad de Oviedo

Oviedo, Principality of Asturias, 33006, Spain

Location contact

Rubén Cuesta-Barriuso

CONTACT

[email protected]

607547274

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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)

Primary outcomes

  1. Measurement of physical activity level

    Time frame: Screening visit.

    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.

Secondary outcomes

  1. Measurement of kinesiophobia (fear of movement or physical exertion)

    Time frame: Screening visit

    This variable will be assessed using the Spanish validated version of the Tampa Scale for Kinesiophobia. The scale consists of 11 items with a 4-point Likert-type response format. Total scores range from 11 to 44, with higher scores indicating greater levels of kinesiophobia.

  2. Measurement of physical activity self-efficacy

    Time frame: Screening visit

    This variable will be assessed using the Physical Activity Self-Efficacy Scale, which consists of 10 items evaluating the individual's perceived confidence in maintaining exercise behavior in the presence of common barriers. The total score will be used as a continuous variable, with higher values indicating greater perceived self-efficacy.

  3. Measurement of perceived fatigue

    Time frame: Screening visit

    Perceived fatigue will be assessed using the Fatigue Severity Scale (FSS), which consists of 9 items rated on a scale from 1 (never) to 7 (always). The score will be expressed as the mean of the item responses. A mean score ≥ 4 will be considered indicative of clinically significant fatigue.

  4. Measurement of musculoskeletal pain

    Time frame: Screening visit

    This variable will be assessed using the Spanish version of the Brief Pain Inventory-Short Form (BPI-SF). The pain severity and pain interference subscales will be used, expressed as mean scores on a 0-10 scale, where higher values indicate greater pain intensity or functional interference due to pain.

  5. Measurement of history of cardiovascular surgery

    Time frame: Screening visit

    This cardiovascular clinical factor will be recorded as a dichotomous variable (Yes/No).

  6. Measurement of history of aortic dissection

    Time frame: Screening visit

    This cardiovascular clinical factor will be recorded as a dichotomous variable (Yes/No).

  7. Measurement of current cardiovascular treatment

    Time frame: Screening visit

    This cardiovascular clinical factor will be recorded as a dichotomous variable (Yes/No).

  8. Measurement of presence of current or stable aortic pathology

    Time frame: Screening visit

    This cardiovascular clinical factor will be recorded as an ordinal variable (Yes/No/Unknown).

Other outcomes

  1. Measurement of age

    Time frame: Screening visit

    This variable, considered a potential confounder or moderator, will be measured as a quantitative variable (years).

  2. Measurement of gender

    Time frame: Screening visit

    This variable, considered a potential confounder or moderator, will be measured as a qualitative variable (male/female).

  3. Measurement of body mass index

    Time frame: Screening visit

    This variable, considered a potential confounder or moderator, will be measured as a quantitative variable calculated from body weight (kg) and height (m).

  4. Measurement of time since diagnosis of Marfan syndrome

    Time frame: Screening visit

    This variable, considered a potential confounder or moderator, will be measured as a quantitative variable (years).

  5. Measurement of current medical recommendation regarding physical exercise

    Time frame: Screening visit

    This variable, considered a potential confounder or moderator, will be measured as an ordinal categorical variable (restricted / unrestricted / unknown).

  6. Measurement of current pain

    Time frame: Screening visit

    This variable, considered a potential confounder or moderator, will be measured as a quantitative variable using a numerical rating scale (NRS 0-10). This measure is already included in the BPI-SF and will be used solely as a descriptive control variable

Study contacts

Contact information is provided by the study sponsor or research team.

Rubén Cuesta-Barriuso, PhD

CONTACT

[email protected]

0034 985103386

Sponsors and collaborators

Lead sponsor

University of Oviedo

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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