Marfan SyndromeNCT07419386
Clinical and Psychosocial Factors Associated With Physical Activity Level in Adults With Marfan Syndrome
An observational study of Marfan Syndrome, run by University of Oviedo at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Marfan Syndrome
- What is being tested?
- Adults with Marfan syndrome
- How many people
- 118 participants
- Where
- 1 siteSpain
- Study dates
- 22 Feb 2026to 26 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with Marfan syndrome
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Universidad de Oviedo
Oviedo, Principality of Asturias, 33006
Rubén Cuesta-Barriuso, 607547274, cuestaruben@uniovi.es
About this study
Official title: Clinical and Psychosocial Factors Associated With Physical Activity Level in Adults With Marfan Syndrome: A Cross-Sectional Observational Study
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.
Read more
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
- Being tested
- Adults with Marfan syndrome
- Keywords
- Marfan syndrome, Motor activity, Exercise, Kinesiophobia, Fatigue, Pain, Self efficacy
- Medical subject headings
- Marfan Syndrome, Motor Activity, Kinesiophobia, Fatigue, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adults with Marfan syndromeOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Observational group | Adults with a diagnosis of Marfan syndrome Receives: Other: Adults with Marfan syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening visit.
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Screening visit
Measurement of history of cardiovascular surgery
This cardiovascular clinical factor will be recorded as a dichotomous variable (Yes/No).
Measured: Screening visit
Measurement of history of aortic dissection
This cardiovascular clinical factor will be recorded as a dichotomous variable (Yes/No).
Measured: Screening visit
Measurement of current cardiovascular treatment
This cardiovascular clinical factor will be recorded as a dichotomous variable (Yes/No).
Measured: 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).
Measured: Screening visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start22 Feb 2026 (estimated)
- Primary completion13 Apr 2026 (estimated)
- Study completion26 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Marfan SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oviedo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruben Cuesta Barriuso, University of Oviedo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07419386
- Sponsor's protocol ID
- ActMarf
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Psychosocial Factors Associated With Physical Activity Level in Adults With Marfan Syndrome: A Cross-Sectional Observational Study
- ClinicalTrials.gov ID
- NCT07419386
- Acronym / sponsor ID
- ActMarf
- Conditions
- Marfan Syndrome
- Keywords
- Marfan syndrome, Motor activity, Exercise, Kinesiophobia, Fatigue, Pain, Self efficacy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- University of OviedoUniversity, hospital or other
- Study start
- 22 Feb 2026 (estimated)
- Primary completion
- 13 Apr 2026 (estimated)
- Study completion
- 26 May 2026 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group | – | Other: Adults with Marfan syndromeAdults with a diagnosis of Marfan syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with Marfan syndrome
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adults with Marfan syndromeAssessment 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) | Other | Observational group |
Primary outcome
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.
8 secondary outcomes
Measurement of kinesiophobia (fear of movement or physical exertion)
Time frame: Screening visit
Measurement of physical activity self-efficacy
Time frame: Screening visit
Measurement of perceived fatigue
Time frame: Screening visit
Measurement of musculoskeletal pain
Time frame: Screening visit
Measurement of history of cardiovascular surgery
Time frame: Screening visit
Measurement of history of aortic dissection
Time frame: Screening visit
Measurement of current cardiovascular treatment
Time frame: Screening visit
Measurement of presence of current or stable aortic pathology
Time frame: Screening visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Marfan Syndrome, run by University of Oviedo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rubén Cuesta-Barriuso, PhD (0034 985103386, cuestaruben@uniovi.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of physical activity level (time frame: Screening visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.