Clinical trials

This study evaluates whether a brief educational workshop can improve knowledge of healthy habits and postural hygiene in primary school children. The study will be conducted in 3rd grade students (8-9 years old) from a primary school in Spain. Children in the intervention group will attend a 45-minute health promotion workshop covering physical activity, correct posture in daily activities, backpack organization and basic musculoskeletal self-care. Children in the control group will not receive the workshop during the initial phase. All participating students will complete a short knowledge questionnaire before and after the workshop period. The study aims to determine whether children who receive the workshop show greater improvement in knowledge compared to those who do not. Participation is voluntary and requires written informed consent from parents or legal guardians. No medical procedures, treatments, access to medical records or biological samples are involved. Data will be coded and treated confidentially.

This study aims to evaluate whether a short educational session about safe therapeutic exercise during pregnancy can improve knowledge, confidence, and physical activity levels in pregnant women. Although exercise during pregnancy is safe and beneficial, many women have doubts or lack information about how to exercise correctly. This can lead to low physical activity levels during pregnancy. In this pilot randomized controlled trial, pregnant women attending primary care health centers will be invited to participate. After completing baseline questionnaires, participants will be randomly assigned to one of two groups. The control group will receive standard prenatal information provided during routine care. The experimental group will receive standard care plus a structured educational session about therapeutic exercise during pregnancy. Participants will complete questionnaires measuring knowledge about exercise during pregnancy, confidence to exercise safely, and physical activity levels before the intervention and two weeks afterward. The study is educational only. No mandatory physical exercise is required, and usual medical care will not be modified. The results will help determine whether brief educational interventions can support healthier lifestyles during pregnancy.

Background. Primary hypothyroidism, both clinical and subclinical, is frequently associated with persistent fatigue, reduced psychological well-being, and lower levels of physical activity in adult women. However, evidence integrating these psychosocial factors remains limited and methodologically heterogeneous. Objective. To analyze the association between physical activity and fatigue, social support, and psychological well-being in women with primary hypothyroidism; to compare these profiles between clinical and subclinical hypothyroidism; and to explore the moderating effect of social support and psychological well-being on the relationship between fatigue and physical activity. Methods. An observational, analytical, multicenter cohort study will be conducted including 96 adult women with primary hypothyroidism from the Principality of Asturias. Physical activity levels will be assessed using the International Physical Activity Questionnaire-Short Form (IPAQ-SF), while fatigue, social support, and psychological well-being will be measured using the Fatigue Severity Scale (FSS), the Medical Outcomes Study Social Support Survey (MOS-SSS), and the WHO-5 Well-Being Index, respectively. Confounding variables will include age, body mass index, type of hypothyroidism (clinical or subclinical), and time since diagnosis. Descriptive analyses, comparisons between clinical and subclinical groups, and multiple linear regression models will be performed. Expected results. The study is expected to identify physical activity levels within the sample and determine which psychosocial factors are independently associated with physical activity. Additionally, fatigue is anticipated to be negatively associated with physical activity, whereas social support and psychological well-being are expected to show positive associations and potential moderating effects.

Background. Rhythmic gymnastics is a sport characterized by high physical and aesthetic demands and typically early competitive retirement. In this context, athletic identity and body image play a central role during the athletic career and may be compromised after retirement, particularly in aesthetic disciplines. However, the relationship between these constructs in retired rhythmic gymnasts has been scarcely investigated. Objective. To analyze the relationship between athletic identity and body image in retired rhythmic gymnasts, in order to better understand the psychosocial factors influencing post-retirement adaptation. Methods. An observational, analytical, cross-sectional study will be conducted using a self-administered online survey targeting retired rhythmic gymnasts aged ≥18 years. The primary study variables will be positive body image and residual athletic identity. Additional independent and predictive variables will include sociodemographic characteristics and sport career-related factors (age, age at initiation in rhythmic gymnastics, duration of the athletic career, highest competitive level achieved, and satisfaction with the athletic career). A set of potential confounding or moderating variables will also be considered (time since retirement and type of sport retirement). Statistical analyses will include descriptive statistics, bivariate analyses, and multiple linear regression models adjusted for potential confounders. Expected results. An association between residual athletic identity and body image after sport retirement is expected, moderated by time since retirement and type of retirement, with implications for identifying profiles of greater vulnerability and informing the design of preventive interventions.

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.

Background. Systemic lupus erythematosus is a chronic autoimmune disease. Among its main clinical manifestations are musculoskeletal symptoms such as myopathies, arthritis, arthralgias or osteonecrosis. Physical activity can improve the perception of quality of life and well-being of these patients. Objective. To assess the degree of physical activity in patients with systemic lupus erythematosus, and to identify the main clinical, sociodemographic and anthropometric variables that influence it. Method. Ambispective cohort study. Sixty-three patients with systemic lupus erythematosus will be recruited. The primary variable will be the degree of physical activity (International Physical Activity Questionnaire). Secondary and modifying variables will be: fatigue (Fatigue Assessment Scale), health-related quality of life (Short Form-36 Health Survey), sleep disorders (Pittsburgh Sleep Quality Index), depressive (Beck Depression Inventory -II) and anxiety symptoms (Hamilton Anxiety Rating Scale), age, and disease activity, duration and damage. Possible confounding variables will be sex, toxic habits (smoking), diagnosis of other pathologies and exposure to therapy. In the analysis, the degree of physical activity of patients with lupus erythematosus will be calculated and a multiple regression analysis will be performed to evaluate the predictive model that best fits the degree of activity of these patients. Expectedresults. To identify the degree of physical activity of patients with systemic lupus erythematosus and to identify the predictive model of physical activity in these patients.

This study aims to analyze the prevalence of temporomandibular joint disorders (TMD) in wind musicians, differentiating the impact by instrument type (woodwind vs. brass) and identifying potential risk factors (embouchure, posture, practice time). A cross-sectional observational design will be used, including professional and student musicians from orchestras and conservatories.

The goal of this clinical trial is to evaluate the efficacy and safety of shock wave therapy (SWT) in reducing muscle spasticity in patients who have suffered a stroke. The main questions it aims to answer are: Does SWT reduce muscle tone and improve joint range of motion in post-stroke patients with spasticity? Does SWT improve the quality of life for these patients? What side effects, if any, occur during or after SWT? Researchers will compare SWT to conventional spasticity treatments to determine its effectiveness and potential advantages. Participants will: Undergo SWT sessions as part of their rehabilitation protocol over a period of 8 weeks. Attend follow-up visits to assess muscle tone, joint mobility, and overall functional improvement. Complete quality-of-life questionnaires to measure the therapy's impact on daily living.

This observational cross-sectional study investigates the impact of equestrian sports, CrossFit, and gym training on pelvic floor health in both athletes and non-athletes. The study aims to determine whether specific sports are associated with a higher risk of pelvic floor dysfunction, including urinary incontinence, pelvic organ prolapse, and chronic pelvic pain. Participants will complete an online survey that collects demographic information, sports participation details, and pelvic floor health symptoms. The survey includes standardized questionnaires to assess pelvic floor function. Data will be analyzed to compare the prevalence of pelvic floor issues among different sports and between athletes and non-athletes. The study seeks to provide insights into how sports participation influences pelvic health and to raise awareness of pelvic floor dysfunction in both male and female athletes.

Given the high prevalence of deaths per year attributable to tobacco use, improving smoking cessation treatments is an important public health priority Worldwide. It is also known that practicing physical activity (PA) may help smoking cessation. Physical activity trackers have been demonstrated to increase PA levels in different studies with various populations, as a sole intervention or in combination with interventions targeting PA. This study aims to examine the feasibility, effect, and cost-effectiveness of cognitive-behavioral therapy (CBT) + Personalized physical activity (PA) + Physical Activity Tracker use (Fitbit Versa 3®) for smoking cessation. Given the high prevalence of deaths per year attributable to tobacco use, improving smoking cessation treatments is an important public health priority worldwide. In this study, an estimated sample of 128 adult smokers will be randomly allocated to one of the following conditions: 1) CBT for smoking cessation + personalized PA plan + Fitbit Versa 3®; 2) CBT for smoking cessation + personalized PA plan. Mail goals: 1) To examine the feasibility (i.e., adherence, perceived utility, satisfaction) of integrating Fitbit Versa 3® into a CBT protocol for smoking cessation; 2) to examine the effectiveness of CBT for smoking cessation + personalized PA plan + Fitbit Versa 3® and CBT for smoking cessation + personalized PA plan in terms of smoking abstinence rates (point-prevalence and days of continuous abstinence), PA (i.e., steps per day, moderate to vigorous physical activity) and mental health outcomes (anxiety and depression symptoms, emotional dysregulation); 3) to examine the cost-effectiveness of CBT for smoking cessation + personalized PA plan + Fitbit Versa 3® vs. CBT for smoking cessation + personalized PA plan in terms of smoking abstinence rates (point-prevalence and days of continuous abstinence), PA (i.e., steps per day, moderate to vigorous physical activity) and mental health outcomes (anxiety and depression symptoms, emotional dysregulation).