Clinical trials

In Greece, people of different age groups, including young children to older adults, participate in dance exercise training. Although it is well-known that regular participation in dancing is associated with benefits such as entertainment, socialization and increased physical activity, the long-term effects of dancing on metabolic and mental health as well as physical performance remain largely unknown. Therefore, the aim of this study is to investigate the effects of a 6-month dancing exercise intervention on metabolic and mental health and physical performance in premenopausal and postmenopausal women.

Obesity is a major challenge for public health and renders it imperative to reduce its prevalence. High intensity interval training (HIIT) is a form of exercise training that can efficiently induce weight loss in adults with overweight or obesity, even in the absence of dietary intake manipulation. Hybrid type training represents a form of HIIT, that incorporates both cardiorespiratory and musculoskeletal stimuli, by combining multiple types of exercise into a circuit-type, interval style workout. Recent evidence suggests that long-term participation in hybrid HIIT results in significant health-related benefits. However, the molecular mechanisms driving the chronic effects of hybrid HIIT on cardiometabolic and musculoskeletal health remains to be elucidated.

The prevalence of Vitamin D deficiency is significantly higher in adults with overweight/obesity compared to those with normal body mass index (BMI). The "entrapment" of Vitamin D in adipose tissue due to impaired lipolytic stimulation and/or adipose tissue dysfunction has been proposed as the driving mechanism. Exercise training has been proposed as a promising strategy to increase mobilization of Vitamin D from adipose tissue, given its well described role in stimulating lipolysis. Indeed, a recent study revealed that participation in moderate-intensity cardiovascular type exercise over winter can mitigate the decline in 25-hydroxyvitamin D \[25(OH)D\] in adults with overweight/obesity, independent of weight loss. The aim of this study is to investigate the impact of hybrid-type high-intensity interval training over winter on vitamin D metabolism, in adults with overweight/obesity.

We ought to investigate if hip fracture patients suffering from frailty have higher inflammatory burden according to simple inflammatory biomarkers.

This study will evaluate the impact of complex thoraco-abdominal aortic aneurysm repair in coagulation during the immediate postoperative period in patients undergoing omplex thoraco-abdominal aortic aneurysm repair.

This study attempts to the translation and the cultural adaptation of the Groningen Frailty Indicator (GFI) questionnaire in the Greek population in patients suffering from hip fracture.

This randomized controlled trial aims to evaluate the effectiveness of the "Algo(S)Therapy" Pain Neuroscience Education (PNE) program in patients with chronic musculoskeletal pain. The study will assess whether the integration of communication skills training for physiotherapists enhances the outcomes of PNE. Participants will be randomly assigned to one of three groups: (1) PNE with communication-focused delivery, (2) PNE without communication emphasis, or (3) standard- usual physiotherapy care. The primary objective is to determine whether PNE combined with enhanced communication skills leads to greater improvements in pain, function, and psychosocial outcomes compared to the other interventions.

Cerebral palsy is one of the most common causes of physical disability in childhood and is often associated with impaired trunk control, reduced upper limb strength, and limitations in functional mobility and daily activities. Trunk control is essential for postural stability and directly influences upper limb function and the ability to perform goal-directed tasks. Neurodevelopmental Treatment (NDT/Bobath) and functional physiotherapy are widely used approaches in pediatric neurorehabilitation. NDT/Bobath focuses on facilitating postural control and promoting efficient movement patterns, while functional physiotherapy emphasizes task-specific training and the improvement of motor performance through meaningful activities. However, evidence comparing the effectiveness of these approaches on trunk control and upper arm strength remains limited. This study aims to investigate and compare the effectiveness of Neurodevelopmental Treatment (NDT/Bobath) and functional physiotherapy on upper arm strength and trunk control in children with cerebral palsy. Participants will be allocated to different intervention groups, with each group receiving one of the two therapeutic approaches. Additionally, wearable Inertial Measurement Units (IMUs) will be used to provide objective and quantitative assessment of trunk movement under both static (sitting) and dynamic (functional movement) conditions. We hypothesize that both intervention groups will demonstrate improvements in trunk control and upper arm strength, with potential differences in the magnitude of improvement between the two approaches. Furthermore, IMU-based measurements are expected to detect subtle changes in movement quality that may not be captured by traditional clinical assessment tools. The findings of this study may contribute to a better understanding of the comparative effectiveness of commonly used therapeutic approaches and support evidence-based decision-making in pediatric rehabilitation.

Rheumatic diseases constitute a group of non-communicable diseases characterized by chronic inflammation. The most common autoimmune rheumatic diseases (ARDs) are rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, myositis, Sjogren's syndrome and systemic scleroderma. These autoimmune disorders lead to joint destruction and adversely influence the human body systemically. One of their characteristics is comorbidity, since patients usually suffer also from other pathologies such as cardiovascular diseases and obesity. In addition, their treatment requires a combination of both biological and conventional pharmaceutical interventions as well as other parameters such as physical activity programs, nutrition, and the use of smart electronic devices. Therefore, the ARDs burden health systems worldwide. Apart from the physiological manifestations of ARDs, specific changes are observed at the cellular and molecular level. A common biochemical/molecular symptom of these diseases is oxidative stress. This condition leads to the disturbance of blood and tissue redox status due to the excessive production of free radicals. Given that free radicals are highly reactive moieties with strong oxidative capacity against biomolecules (i.e., proteins, lipids, DNA), they compromise the efficacy of the intrinsic antioxidant mechanisms and, finally, induce the disruption of redox homeostasis. However, there is no sufficient data linking the levels of redox status of patients with the progression of ARDs over time. Indeed, the onset and symptoms of ARDs are intertwined with the disruption of the patient redox homeostasis and the induction of oxidative stress. Concurrently, the absence of a completely effective pharmaceutical treatment emerges the need for the adoption of novel biomarkers for monitoring the severity of the symptoms and the evolution of ARDs in general. To that end, this study aims at first to investigate the blood redox status of patients with ARDs. Thus, specific redox biomarkers will be evaluated in the blood of patients in three time points (i.e., at Days 1, 180 and 360), and they will be associated with the clinical manifestations of their diseases. The ultimate goal is to clarify whether these biomarkers could putatively exert clinical significance, namely whether they could constitute an additional tool for the monitoring of the progression of these diseases in clinical practice.

The existence of social inequalities is a major global issue and a salient challenge for the European Union. During COVID-19 pandemic, health disparities became more evident. Indeed, the low-income residents in several European countries, including Greece, had limited access to the healthcare system for several reasons. In addition, vulnerable populations, with patients suffering from opioid use disorders and incarcerated individuals being among them, do not have the same chances regarding health services, compared to the general population. According to the World Health Organization, physical activity is a key non-pharmaceutical intervention for both prevention of chronic non-communicable diseases and address of social health inequalities. Thus, this study will focus on specific population groups of the Region of Thessaly, Greece, who have limited access to healthcare services. It aims, primarily, to the assessment of demographic characteristics (i.e., body mass index, alcohol consumption, smoking, educational level etc), which are fundamental parameters for the assessment of health inequalities. Secondly, quality of life, physical activity levels and biomarkers in the level of Biochemistry (i.e., blood oxidative stress and inflammation) and Physiology (i.e., cardiorespiratory fitness, body composition) will be collected a well. All data will be integrated into an interactive digital platform that will be accessible by any putative stakeholder in the area of health system or administration. Based on scientifically robust data and evidence-based findings, the research team of the project will draft recommendations and guidelines that will be communicated to all stakeholders. To that end, the problem of limited access to health system that the examined populations face, will be highlighted and targeted actions and policies are expected to be adopted by local (i.e., in the province of Thessaly) and national (i.e., Greek) authorities. In this respect, non-pharmaceutical interventions and guidelines will be proposed towards the trajectory of holistically approaching the issue of health inequalities.

The purpose of this study is to examine the effect of sideritis consumption on physiological and performance indicators in adult subjects and compare it with the control trial.

The escalating environmental heat-stress associated with global warming is a societal challenge with large and potential harmful consequences for humans. Excess morbidity and mortality during heat waves provides strong evidence for fatal outcomes. However, it is unclear why some people are particularly vulnerable and get sick from hyperthermia, while others adapt and tolerate exposure. The Icarus project aims to provide a psycho-physiological framework for improved mitigation of the health threats associated with global warming. Combining expertise in integrative thermal physiology, pharmacology, photobiology, psychology and machine learning, we will collaborate on comprehensive cross-scientific studies using controlled lab-exposure combined with investigations in ecological settings including vulnerable and highly tolerant people across populations from northern to southern Europe. Advanced algorithms will be developed to generate personalized alerts and advising based on behavioral patterns, psychological profiling, predicted vulnerability and willingness to adopt resilience-building strategies. Global warming is projected to continue towards the end of the 21st century and constitutes an increasing threat to human health unless we as individuals and collectively become better in preventing acute effects, as well as devise sustainable strategies to limit further anthropogenic warming of the climate system. Acutely, improved guidance is important for both individual and public health, where Icarus aims at providing a highly improved basis for preventing heat-related disease, advising or nudging people towards pro-health behavior, including smarter use of technologies to mitigate heat stress, or adjusting medication to reduce adverse effects during heat events. In support of the sustainability agenda, our framework also forms a novel basis for developing advising algorithms relevant for optimization of climate change mitigation policy-making.

Type of study: Randomized controlled study Investigated Procedure: Artificial Intelligence Software for Polyp Detection in Colonoscopy training Trial participants: Endoscopy trainees during their training with at least one year of training ahead and no previous structured exposure to CADe Objectives: Primary: Adenoma Miss Rate (AMR) in the end of the first year of training for each group and after the crossover. Secondary: Further endoscopists-related parameters will be recorded and compared between the two arms: PDR, ADR, aADR, PMR, withdrawal time, CIR, AEs The investigators will be asked, when possible, to follow-up the patients until they have their next colonoscopy or a diagnosis of CRC to assess for interval cancer.

Failure of liberation from mechanical ventilation increases days spent being mechanically ventilated, the length of stay and the morbidity of patients. Thus it is crucial that those patients who are ready to be liberated are accurately detected. In this study the investigators want to externally validate an index (the volume-velocity index, VVI) which in a preliminary study was found to predict with high accuracy the outcome of ventilator liberation. In this study, in patients who are deemed ready to undergo weaning by their treating physician the investigators will measure the excursion of the diaphragm, the principal respiratory muscle, the inspiratory time and the tidal volume and the volume breathed by the patient at each respiration in three phases: 1. during pressure support ventilation with 5/5, 2. during pressure support ventilation with 8/0, 3. during t-tube or pressure support ventilation with 0/0. All of these phases are ventilatory modalities widely used during weaning from mechanical ventilation. The investigators will evaluate whether VVI can predict accurately the weaning outcome.

This is a prospective, single-center, two-arm (1:1), assessor-blinded, randomized controlled clinical trial that will be conducted in collaboration with the outpatient clinic of the third Pediatric Pulmonology Unit, "Attikon" University Hospital of Athens in Greece. The aim of the study is to investigate the effects of applying digital physiotherapy services in the management of specific clinical outcomes in children with chronic suppurative lung diseases, other than cystic fibrosis. The research question is whether airway clearance techniques and exercise training that are performed remotely using digital health services (DHSs) can improve functional and exercise capacity, as well as compliance with ACTs, compared to usual care. The intervention program includes airway clearance techniques (ACTs), as well as aerobic and strengthening exercises that can be implemented easily in an online setting at home with minimal equipment. The duration of the program will be 12 weeks, and the prescribed weekly regimen will consist of 50-minute remote sessions: two synchronous, supervised sessions conducted via the Vsee platform, and a minimum of one asynchronous, unsupervised session. Children will be encouraged to maintain daily adherence to the exercise protocol.

The primary objective of the present postdoctoral research is to evaluate the acceptability and adherence of two dietary supplements containing microbial phytase, Goodphyte IB Defense and Goodphyte Immunity, in adult individuals with chronic diseases, namely Idiopathic Inflammatory Bowel Diseases (IIBD)-that is, Crohn's disease (CD) or Ulcerative Colitis (UC)-Arterial Hypertension (AH), Anemia (AN), or Multiple Sclerosis (MS). Secondarily, this study will investigate potential changes in iron and zinc absorption following phytase supplementation in these individuals and, consequently, possible changes in their quality of life.

This open-label interventional study aims to evaluate the acceptability and adherence of adult participants to the multistrain probiotic Vivomixx® 460 Neo 9 when administered concurrently with antibiotic therapy. Participants are randomized to receive one of two dosing regimens: a low daily dose or a high daily dose. The study will assess the effects of these regimens on the prevention of antibiotic-associated diarrhea (AAD), gastrointestinal symptoms, and patient adherence and acceptability. The results are intended to provide evidence to optimize the clinical use of probiotics alongside antibiotics.

The goal of this clinical trial is to examine the compliance and acceptability of the probiotic Smile Probio 45B in healthy adults, as well as its effect on gastrointestinal symptoms, fatigue levels, and quality of life. Specifically, the study examines the effect of probiotic intake on improving health-related quality of life, reducing self-reported gastrointestinal symptoms such as bloating, as well as regulating stool consistency and frequency. In addition, its impact on participants' self-reported energy levels is investigated, with a particular emphasis on reducing fatigue symptoms. Participants will: * take 1 capsule daily (with a main meal) during the first and second week of the intervention, and 3 capsules daily (after each main meal) during the third and fourth week of the intervention, for a total duration of 30 days. * complete a three-day food record on a weekly basis. * record their daily bowel habits, including the number of bowel movements and their consistency/form, according to the Bristol Stool Chart, which will be provided to them. * complete questionnaires assessing health-related quality of life \[WHOQOL-BREF (World Health Organization Quality of Life)\],a health status questionnaire \[EQ-5D (EuroQol-5D)\] and a questionnaire evaluating energy levels and fatigue \[Chalder Fatigue Scale (CFQ)\]. * complete, at baseline and at the end of each intervention week a weekly symptom assessment questionnaire. * undergo body composition assessment at the beginning, midpoint, and end of the study. * complete an acceptability questionnaire at the end of the intervention.

This 12-week study protocol outlines a randomized controlled trial designed to evaluate the effectiveness of a Dance-Mindfulness intervention integrating Modern Theatre Dance with mindfulness-based embodied practices to enhance psychological wellbeing, nervous system regulation, and embodied awareness in adults. The intervention combines: (1) polyvagal-informed breath-movement synchronization (nasal breathing, grounding); (2) ISTD (Imperial Society of Teachers of Dancing) Modern Theatre Dance technique progression and dance movements (Grades 2-4); (3) nervous system regulation through somatic practices; and (4) phenomenological reflection via weekly journaling and post-session integration. Study Design: Parallel-assignment randomized controlled trial (approx. N=320; n=160 intervention, n=160 waitlist control). Randomization uses computer-generated block randomization (block sizes 4-6). Outcomes: Perceived stress, mindfulness psychological wellbeing (happiness, life satisfaction), emotional regulation, social connection, movement confidence. Qualitative Component: Phenomenological interviews and weekly reflective journals from subsample (approx. n=20) analyzed via Interpretative Phenomenological Analysis and Reflexive Thematic Analysis. Intervention Delivery: 90-100 minute weekly sessions delivered over 12 weeks by qualified facilitator(s) trained in Modern Theatre Dance, mindfulness (≥3 years personal practice, MBSR, yoga or equivalent), trauma-informed care, and group facilitation. Sessions include 8 structured components: breath-grounding (9-10 min), technical dance work (14-15 min), conditioning (9-10 min), break-settling (4-5 min), rhythm improvisation (8-9 min), choreographed sequences (15-17 min), cool-down-integration (8-9 min), and phenomenological journaling (10-20 min). Safety \& Fidelity: Structured facilitator guidelines, session checklists, weekly supervision, adverse event protocols, and external fidelity monitoring ensure protocol integrity. Classroom size: 15-18 participants per session. Data Collection: Baseline (Week 0), mid-intervention (Week 6 only for qualitative), post-intervention (Week 12), and optional 1-3 month follow-up. Intent to treat analysis and mixed-effects modeling for between-group comparisons. Population: Adults (age 18+) seeking wellbeing enhancement through recreation or stress reduction. Eligible participants without acute mental health crisis. Primary Purpose: Health promotion and mental health improvement through nervous system regulation, embodied awareness, and psychosocial wellbeing enhancement.

The purpose of this study is to assess the reliability (intra-rater and inter-rater) and criterion validity (using a Cybex isokinetic dynamometer as the reference) of the K-Pull (traction) dynamometer for evaluating lower limb function in children with neurotypical development.

Excess fat accumulation is a key feature of overweight and obesity that is mainly driven by nutrient overload and insufficient physical activity. White adipose tissue displays lipid overload and hypertrophy accompanied by macrophages infiltration, hypoxia, inflammation and excess production of reactive oxygen species (ROS). An inflammatory response and ROS production are also evident in other metabolism regulating tissues and organs such as skeletal muscle, liver, pancreas and hypothalamus, contributing to a chronic inflammatory state, redox status disturbances and metabolic complications. There is overwhelming evidence showing that adults with overweight/obesity exhibit lower glutathione (GSH) levels in blood erythrocytes, skeletal muscle cells and subcutaneous and visceral adipose tissue cells. GSH, a tripeptide consisting of the amino acids glutamate, cysteine and glycine, is the most abundant thiol-containing antioxidant in the human body and has been, recently, characterized as a novel therapeutic target for the treatment of numerous chronic diseases, due to its potent intracellular redox buffering capacity. Interestingly, lower GSH levels have been associated with diet-induced weight loss resistance, while enhancement of GSH levels through N-acetylcysteine (NAC) supplementation reduces markers of oxidative stress, inflammation, insulin resistance, hypertension, endothelia dysfunction and improves vitamin D metabolism. NAC is a thiol donor that elicits antioxidant effects by (i) directly scavenging ROS and (ii) providing reduced cysteine through deacetylation, which supports the biosynthesis of endogenous GSH via the activity of γ-glutamylcysteine synthase. The aim of this study is to investigate whether NAC supplementation can enhance the exercise training-induced improvements on physical fitness and metabolic health in adult men and women with overweight/obesity.

The aims of the study are: 1. To examine skeletal muscle and blood metabolites during an official basketball game and to relate those to skeletal muscle performance during and after the game. 2. To investigate whether skeletal muscle and blood metabolites are related to game-induced fatigue. 3. To relate field activity during a basketball game with the responses of skeletal muscle and blood metabolites. 4. To investigate how blood lactate reflects muscle lactate concentration during a basketball game. 5. To determine whether temporary fatigue develops during a basketball game. game.

This randomized controlled trial aims to investigate whether the use of an attention distraction application during exercise increases patient adherence to exercise programs in chronic non-specific low back pain (CNSLBP). In addition, the study will examine whether higher adherence to exercise leads to improved outcomes in pain levels, functional capacity, kinesiophobia, quality of life, central sensitization, and pain catastrophizing.

Aim: This randomized clinical study aims to compare occurrence of DGE in patients undergoing either antecolic or retrocolic gastrojejunostomy following pancreaticoduodenectomy. Methods: Participants of this study will be patients undergoing pylorus preserving pancreaticoduodenectomy at the Surgical Department of the University Hospital of Larissa. Patients will be randomized to undergo either an antecolic or a retrocolic gastrojejunostomy and the occurrence of DGE will then be compared between the two groups. Individuals younger than 18 or older than 75 years old, as well as patients who do not consent to participate in this trial, will be excluded. Expected results: Based on available literature, antecolic gastrojejunostomy may be related with a lower incidence of DGE, without a statistically significant difference between the two methods. We aim to show if one of the two methods of gastrointestinal reconstruction (antecolic versus retrocolic) affects DGE.

Previous evidence suggests that though N-acetylcysteine (NAC) supplementation following eccentric exercise-induced muscle damage disrupts the skeletal muscle's repair and remodelling process at 8 days of recovery, it attenuates substantially the decline of skeletal muscle performance during the first 48 hours of recovery. The enhanced performance capacity during the first phase of recovery in response to NAC supplementation might be attributed to the altered redox status in skeletal muscle as a consequence of the NAC-mediated elevation of reduced glutathione (GSH) levels. The rise in GSH results in a redox-dependent attenuation of immune cell mobilisation and reduction of oxidative stress response, leading to a blunted rise of muscle damage and inflammatory markers during the first 2-3 days of recovery. However, following exercise-induced muscle damage, protein synthesis increases in skeletal muscle over the next 24-48 hours to support its repair process, and thus protein supplementation might accelerate the recovery process by enhancing the protein synthetic response. Therefore, the present study aims at investigating for first time the combined effect of NAC and whey protein supplementation on the short-term (during the first 72 hours) recovery process of skeletal muscle following damaging exercise (eccentric exercise) and compared it with the well-documented efficacy of NAC supplementation. The results of this study might be particularly useful for athletes, such as those in soccer and basketball, that participate in 3 games or intense training sessions during the same macrocycle with only 48-72 hours of recovery in-between.