An observational study in Marfan Syndrome, sponsored by University of Oviedo. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by University of Oviedo · Observational
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.
61 studies on the registry are indexed under Marfan Syndrome; 15 are open to participants now.
This study's planned enrollment of 118 is below the median of 144 across 34 observational studies indexed under Marfan Syndrome.
Browse Marfan Syndrome studies →University of Oviedo is the lead sponsor of 47 studies on the registry; 10 are open to participants now.
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Adults with Marfan syndrome
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with a diagnosis of Marfan syndrome
Other: Adults with Marfan syndrome
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)
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.
Time frame: Screening visit.
Measurement of kinesiophobia (fear of movement or physical exertion)
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.
Time frame: Screening visit
Measurement of physical activity self-efficacy
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.
Time frame: Screening visit
Measurement of perceived fatigue
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.
Time frame: Screening visit
Measurement of musculoskeletal pain
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.
Time frame: Screening visit
Measurement of history of cardiovascular surgery
This cardiovascular clinical factor will be recorded as a dichotomous variable (Yes/No).
Time frame: Screening visit
Measurement of history of aortic dissection
This cardiovascular clinical factor will be recorded as a dichotomous variable (Yes/No).
Time frame: Screening visit
Measurement of current cardiovascular treatment
This cardiovascular clinical factor will be recorded as a dichotomous variable (Yes/No).
Time frame: Screening visit
Measurement of presence of current or stable aortic pathology
This cardiovascular clinical factor will be recorded as an ordinal variable (Yes/No/Unknown).
Time frame: Screening visit
Measurement of age
This variable, considered a potential confounder or moderator, will be measured as a quantitative variable (years).
Time frame: Screening visit
Measurement of gender
This variable, considered a potential confounder or moderator, will be measured as a qualitative variable (male/female).
Time frame: Screening visit
Measurement of body mass index
This variable, considered a potential confounder or moderator, will be measured as a quantitative variable calculated from body weight (kg) and height (m).
Time frame: Screening visit
Measurement of time since diagnosis of Marfan syndrome
This variable, considered a potential confounder or moderator, will be measured as a quantitative variable (years).
Time frame: Screening visit
Measurement of current medical recommendation regarding physical exercise
This variable, considered a potential confounder or moderator, will be measured as an ordinal categorical variable (restricted / unrestricted / unknown).
Time frame: Screening visit
Measurement of current pain
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
Time frame: Screening visit
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Feb 2026; primary completion for Apr 2026, 1 month later.
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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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University of Oviedo