Clinical and Psychosocial Factors Associated With Physical Activity Level in Adults With Marfan Syndrome: A Cross-Sectional Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Measurement of physical activity level
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Observational group
Adults with a diagnosis of Marfan syndrome
干预措施: Adults with Marfan syndrome (Other)
结局指标
主要结局
Measurement of physical activity level
时间窗: 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.
次要结局
- 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)
- Measurement of history of aortic dissection(Screening visit)
- Measurement of current cardiovascular treatment(Screening visit)
- Measurement of presence of current or stable aortic pathology(Screening visit)
研究者
Ruben Cuesta Barriuso
Principal Investigator
University of Oviedo