Search Results (550)

The administration of enteral nutritional therapy (ENT), combined with the use of probiotics, is considered a proactive therapeutic strategy that can modulate the intestinal microbiota, resulting in beneficial effects on intestinal integrity and function, as well as on the immune system of patients. This review aimed to find evidence on the clinical effects of probiotic administration in treating patients using ENT. An integrative search was performed to select scientific articles on the use of probiotics in ENT published in the last 10 years (2014–2025) using PubMed, ScienceDirect, Scielo, and Google Scholar databases. The descriptors used in the search were “probiotics” AND “enteral nutrition” OR “tube feeding” AND “adults” AND “critical illness”. Retrospective studies, pilot single/double-blind placebo-controlled clinical trials, and randomized trials investigating the effects of probiotic supplementation in enteral nutrition were included. A review of 21 manuscripts was conducted, in which all patients received ENT with probiotics, with 14 monitored in the ICU, 4 in the ward, and 3 at home. All 21 studies reviewed included a control group using enteral nutrition alone or a placebo, and some also included the study of other treatments. All studies demonstrated clinical benefits of some nature for patients who received enteral nutrition associated with the use of probiotics, such as reduced hospitalization time, improvement in the gastrointestinal tract, reduction in diarrhea associated with the use of antibiotics and inflammatory and immunological responses, and reduction in the incidence of pneumonia associated with mechanical ventilation. Probiotic supplementation in adult patients using enteral nutritional therapy demonstrates benefits that help promote health and improve intestinal microbiota composition. No side effects or adverse risks have been reported. Full article

Multiple sclerosis (MS) is a chronic disease of the central nervous system that significantly impairs gait and mobility, contributing to a high risk of falls, reduced participation in daily activities, and diminished quality of life. Despite existing interventions such as exercise programs and pharmacological treatments, challenges such as fatigue, pain, and limited accessibility underscore the need for alternative therapies. Focal vibration therapy (FVT) has shown promise in improving gait, reducing spasticity, and enhancing mobility in people with MS (PwMS). However, further research is required to evaluate its long-term feasibility and optimize its parameters. This study examined the feasibility and preliminary efficacy of a home-based four-week wearable FVT device on gait and explored how FVT parameters impact gait and mobility outcomes. In this pilot double-blind randomized controlled trial, 22 PwMS were randomized into control and vibration groups (four FVT groups with varying vibration intensities/durations). Participants wore Myovolt^® vibrators on distal quadricep muscles near the rectus femoris insertion (approximately 2 cm from the medial edge of the patella), gastrocnemius/soleus, and tibialis anterior muscles (10 min/muscle, 3 days/week, 4 weeks). Feasibility was evaluated via adherence and satisfaction (QUEST 2.0, interviews). Gait (3D motion analysis) and mobility (T25FW) were assessed at baseline and post-intervention. Data were analyzed using descriptive/inferential statistics and thematic analysis. Of 22 participants, 17 completed post-intervention (16 intervention, 1 control). Wearable FVT showed promising feasibility, with high satisfaction despite minor adjustability issues. Intervention groups improved gait speed (p = 0.014), stride length (p = 0.004), and ankle angle (p = 0.043), but T25FW was unchanged (p > 0.05). High-intensity FVT enhanced knee/hip moments. This study’s results support the feasibility of wearable FVT for home-based management of mobility symptoms in MS with high participant satisfaction and acceptance. Notable gains in gait parameters suggest FVT’s potential to enhance neuromuscular control and proprioception but may be insufficient to lead to mobility improvements. Subgroup analyses highlighted the impact of vibration intensity and duration on knee joint mechanics, emphasizing the need for personalized dosing strategies. Challenges included participant retention in the control group and burdensome biomechanical assessments, which will be addressed in future studies through improved sham devices and a larger sample size. Full article

Background/Objectives: Advanced lung cancer is a highly distressing disease that negatively impacts older adults. Supportive care interventions designed for this population are scarce and often inaccessible due to competing demands and transportation access. We adapted and refined an evidence-based treatment, Self-System Therapy (SST), to address the unmet needs of older adults with advanced cancer. Methods: Guided by principles of implementation science, we conducted patient interviews, focus groups, and user testing to refine our new SST for the lung cancer (SST-LC) protocol. We then conducted a single-arm pilot trial (clinicaltrials.gov NCT04057196) for patients aged 65+ and above with Stage III or IV lung cancer (N = 30). Benchmarks for acceptability, feasibility, and preliminary changes in outcome measures were assessed. Results: Our study met the desired recruitment goals and demonstrated high treatment adherence rates (89%) and satisfaction rates (85%), indicating that SST-LC was feasible and well-received. Participants also showed reductions in distress and depression, and improvements in emotional and functional well-being from baseline to post-intervention, with effects mostly maintained at follow-up. Physical well-being, social well-being, and quality of life showed smaller, non-significant changes. Feedback from participants also suggested that SST enhanced their resilience and ability to cope with cancer-related challenges, but also indicated a preference for fewer sessions. Conclusions: SST for older adults living with advanced lung cancer is feasible and acceptable. Moreover, this supportive care intervention shows promise in addressing psychological distress, emotional well-being, and functional well-being in older adults. Future research will include testing the efficacy of SST in a larger randomized controlled trial. Full article

Routine collection of Patient-Reported Outcomes (PROs) can enhance patient–pharmacist communication and identify medication-related concerns. This study aims to explore the influence of RxTalk™, an electronic PRO tool, on patients’ attributes and the dynamics of communication. Secondary aims include describing patients’ experiences with RxTalk™ and identifying suggestions for improvements. This study is part of a pilot randomized controlled trial in which patients used RxTalk™ in the pharmacy while being observed before they spoke with the pharmacist. Patients’ interactions with pharmacists were tape-recorded and analyzed, and patients were interviewed within one week. We integrated data from RxTalk™, patient observations, taped encounters, and interviews to provide a thicker description of patients’ experiences with RxTalk™ and its impact on their communication. A total of 70% of patients found RxTalk™ easy to use, and 59% perceived RxTalk™ as very useful to extremely useful. Triangulated findings show that RxTalk™ met patients’ social and informational needs, improved their communication skills, and cultivated a sense of privacy to share concerns. Furthermore, RxTalk™ validated the appropriateness of reporting any health concerns, not simply medication concerns. As patients had a positive experience with RxTalk™, pharmacists should consider integrating PRO tools into their daily services to improve patient interactions and quality of care. Full article

Background/Objectives: Breast cancer-related lymphedema (BCRL) is more prevalent and severe in women with overweight or obesity. This study evaluated the effect of a comprehensive lifestyle intervention—comprising supervised exercise, a hypocaloric Mediterranean diet, and optional meal replacement—on lymphedema outcomes in this population. Methods: In this pilot randomized controlled trial, 112 women with BCRL and BMI 25–40 kg/m² were assigned to an intervention group—receiving supervised resistance and aerobic training, dietary counseling, and optional high-protein meal replacement—or to a control group with standard advice. The primary outcome was change in affected limb volume at 3 and 6 months. Secondary outcomes included morphofunctional parameters, muscle strength, dietary intake, and serum levels of cytokines (IL-1β, IL-6, IL-10, and TNF-α). Analyses also explored outcomes according to whether participants achieved ≥ 5% weight loss. Results: Ninety-four participants completed the trial (intervention n = 43, control n = 51). At 6 months, women who achieved ≥5% weight loss had greater reductions in affected limb volume (−664.9 ± 362.1 mL vs. −395.6 ± 596.9 mL). The intervention group showed significantly greater improvements in BMI (−1.14 ± 1.22 kg/m²), waist circumference (−3.59 ± 4.6 cm), triceps skinfold (−4.61 ± 3.02 mm), fat mass (−2.38 ± 2.75 kg), extracellular water (−0.58 ± 0.85 L), and quadriceps strength (+7.1 ± 9.7 kg). No significant changes were observed in circulating cytokines. Conclusions: In this pilot randomized controlled trial, a structured dietary and exercise intervention improved morphofunctional outcomes in overweight women with BCRL. Weight loss of ≥5% emerged as a potentially relevant therapeutic target that may inform the design of future studies aimed at optimizing lymphedema management. Full article

(1) Background: Idiopathic or familial nasal hyperkeratosis (NHK) may be considered a cosmetic issue in its uncomplicated form. Nevertheless, the prevention of secondary lesions could be advised by proper management. (2) Methods: In this multicentre, prospective, open-label pilot study, dogs with familial or idiopathic NHK received a topical emollient balm twice daily for 60 days. Evaluation of the global dermatological score (GDS; 0–12) on D0, D30, and D60 by owners and investigators was the main outcome. The score’s percentage decrease versus D0; the evolution of “dryness”, “lichenification”, “crusts”, and “affected area” (0–3); the correlation between observers and the evaluation of clinical improvement; and animal discomfort rated using a VAS (0–10) during follow-up were analysed. (3) Results: Twenty dogs completed the study. The mean GDS decreased significantly from Day 0 to Day 30 and Day 60 (p < 0.0001), with percentage reductions of 44.9% and 54.5% (investigators) and 54.3% and 62.3% (owners) on Day 30 and Day 60, respectively. Correlations between investigators and owners were significant for dryness, crusts (at Day 60), and the affected area, but not for lichenification. Animal discomfort scores decreased by more than 50% from Day 0. Owners reported high satisfaction with the product (mean score 8.1/10) and no adverse events occurred. (4) Conclusions: This open-label pilot study suggests that the tested balm is well tolerated and may improve clinical signs of NHK in dogs. Given the lack of a control group, small sample size, and absence of blinding, these results should be considered preliminary. Further randomized controlled trials and formal validation of the scoring system are warranted. Full article

Background/Objectives: Women with Polycystic Ovary Syndrome (PCOS) often report difficulties adhering to dietary interventions due to a combination of physiological and psychological barriers. Therefore, this study explores the feasibility of a Mediterranean diet (MedDiet) intervention as an effective and acceptable dietary approach for managing PCOS. Methods: Women with PCOS and a BMI ≥ 25 kg/m², aged 18–45 years were randomized to an ad libitum MedDiet or Healthy Eating (HE) diet (control). The 12-week intervention incorporated fortnightly, personalized dietary consultations and tailored resources. Primary outcomes were measures of feasibility, including recruitment metrics, data collection methods, and intervention adherence. Acceptability was examined using semi-structured interviews and surveys for those randomized to the MedDiet. Results: Study promotion resulted in n = 380 interested individuals; a total of n = 26 were randomized to either a MedDiet (n = 12) or HE (n = 14) group. Data collection was mostly appropriate as demonstrated by the collection of 100% of anthropometric and biochemical data; however, only 69% of the 4-day food records were returned. Participants reported the intervention was acceptable, and adherence was enhanced through individualized counselling and the provision of practical resources. At week 12, adherence was significantly greater in the MedDiet group compared to HE (8.1 ± 2.4 vs. 4.6 ± 1.0; p = 0.002). Adherence significantly improved from baseline to week 12 in both groups (MedDiet: 3.67 ± 1.32; 8.11 ± 2.37; p ≤ 0.001; HE: 3.57 ± 1.27; 4.57 ± 0.98; p = 0.02). Conclusions: We showed that a 12-week pilot MedDiet intervention is feasible and acceptable for women with PCOS and a BMI ≥ 25 kg/m². Future investigation warrants a larger, adequately powered study which addresses challenges to recruitment, attrition and collection of dietary intake data. Full article

Introduction: There is a lack of knowledge regarding the acute glycemic and blood pressure responses to resistance exercises that involve different amounts of muscle mass. Objective: To analyze the acute effects of single- and multi-joint resistance exercises on glycemic control and blood pressure in individuals with type 2 diabetes (T2DM). Methods: This is a pilot randomized crossover trial, including adults with T2DM of both genders. The participants performed three sessions (two experimental sessions: one with single-joint exercises (SIN) and the other with multi-joint exercises (MULTI); and a control session (CON)) in a randomized order, with outcomes being evaluated pre-exercise, immediately, 15 and 30 min after the sessions. Both sessions consisted of five exercises performed in three sets of 10 to 12 maximum repetitions. Analyses were performed by generalized estimation equations. Results: Fifteen adults (including eleven women) participated in this study. Both experimental sessions showed glycemic reductions immediately after the sessions (MULTI: −17 mg/dL; SIN: −29 mg/dL; p < 0.001), and these values were kept similar up to 30 min after the session. The control session presented a glycemic reduction immediately after the session (−18 mg/dL), which increased 15 min later (−29 mg/dL), stabilizing up to 30 min after the session. Systolic blood pressure was increased immediately after both experimental sessions, retuning to baseline values 15 min post-session. Diastolic blood pressure increased in the control session with time, without any alterations in the experimental sessions. Conclusions: Similar glycemic reductions were found in the experimental sessions, without superiority over the control session. Minimal changes were found in blood pressure. Full article

Background: Mobility plays a fundamental role in causal reasoning (causal inference or cause–effect learning), which is essential for brain development at early ages. Children naturally develop causal reasoning through interaction with their environment. Therefore, children with severe motor disabilities (GMFCS levels IV–V), who face limited opportunities for interaction, often show delays in causal reasoning. Objective: This study investigates how a wheelchair-mounted, semi-autonomous mobility platform operated via a simple switch may enhance causal learning in children with severe disabilities, compared with traditional therapies. However, due to the scarcity of participants who meet the inclusion criteria and the need for long-term evaluation, recruitment poses a significant challenge. This study aims to provide an initial assessment of the platform and collect preliminary data to estimate the required sample size and number of sessions for future studies. Methods: We conducted a pilot randomized controlled trial (RCT) to assess platform usability and its effect on reaction time and keystroke accuracy. Four children, aged 8.5 ± 2.38, participated in seven 30 min sessions. They were randomly assigned in equal numbers, with two participants in the intervention group (using the platform) and two in the control group (receiving standard therapy). Usability was evaluated through a questionnaire completed by two therapists. Key outcome measures included the System Usability Scale (SUS), reaction time (RT), and keystroke accuracy (NIS). Results: Despite the small sample size and recruitment challenges, the data allowed for preliminary estimates of the sample size and number of sessions required for future studies. Therapists reported positive usability scores. Children using the platform showed promising trends in RT and NIS, suggesting improved engagement with cause–effect tasks. Conclusions: The findings support the feasibility and usability of the mobility platform by therapists, although some improvements should be implemented in the future. No conclusive evidence was found regarding the platform’s effectiveness on causal learning, despite a positive trend over time. This pilot study also provides valuable insights for designing larger, statistically powered trials, particularly focused on NIS. Full article

Background/Objectives: Multidisciplinary approaches spanning the physical, cognitive, and social domains of geriatric evaluation are essential to promote functional well-being and reduce the aversive consequences of aging. The main objective of the pilot study, “Multidomain Interventions to improve the COgnitive and fUNctional well-being of elderly individuals in residential sTructures” (I-COUNT), is to assess the feasibility of a 6-month multidomain intervention performed on older adults in Long-Term Care Facilities (LTCFs), compared with a group of residents following a traditional care approach. Methods: The intervention will involve two LTCFs in Italy and will include physical exercise and cognitive training, administered and monitored using wearable technologies, a nutritional program based on the Mediterranean diet enriched with selected functional foods, and the administration of the vaccinations recommended in the national vaccination plan. The I-COUNT study will assess the feasibility and acceptability of the defined protocol and provide information to determine the sample size for a definitive study. In relation to the potential health impact of multidomain interventions on older people living in LTCFs, the primary outcome will consider the change in microbiota composition assessed 3 months after the start of interventions, while secondary outcomes will include the evaluation of changes in selected biomarkers, physical performance, psychological health, cognitive functioning, and nutritional status at 6- and 9-month follow-up points. Conclusions: The I-COUNT study will allow us to assess the feasibility of delivering a multidomain intervention on elderly people. Exploratory findings on potential health effect will support the development of a larger-scale randomized controlled trial. Trial registration number: ClinicalTrials.gov ID NCT06820710. Full article

Background/Objectives: Exam anxiety is a prevalent issue among university students, affecting both their academic performance and overall subjective well-being. There is an increasing need for efficient psychological interventions to support students. This study aimed to assess the effectiveness of a four-session group intervention based on Solution-Focused Brief Therapy (SFBT) in reducing exam anxiety among 1st-year psychology students in Poland. Additionally, it examined the single-session effects of the SFBT on positive and negative emotions and perceived stress. Methods: A pilot study with a randomized controlled trial with a pretest–post-test design was conducted. The 18 participants aged between 19 and 21 years (M = 19.22, SD = 0.55) were assigned to either the intervention group (SFBT) or a waitlist control group. Exam anxiety was evaluated before and after the intervention. In the experimental group, emotional states and perceived stress were measured before and after each session. Results: The two-way analysis of variance ANOVA 2 (therapy: Before, After treatment) × 2 (group: Experimental, Control) showed significant intervention (p < 0.05, η²_p = 0.27) and interaction effects (p < 0.05, η²_p = 0.22). However, the Experimental and Control groups did not differ significantly in exam anxiety (p = 0.32, η²_p = 0.06). Examining changes during each of the four sessions of SFBT in the Experimental group (n = 10), the study showed a significant decrease in stress (p < 0.05, η²_p = 0.47) and negative emotion levels (p < 0.01, η²_p = 0.57) while increasing positive emotions (p < 0.05, η²_p = 0.14), comparing emotional states before and after SFBT sessions. Conclusions: Even a brief, four-session SFBT intervention is effective in reducing exam anxiety in university students. Moreover, single SFBT sessions were linked to immediate improvements in emotional functioning in the experimental sample. Future research should be repeated to investigate the long-term effects of the SFBT on well-being and include a larger and more heterogeneous sample of university students. Full article

Background: Uterine leiomyomas, commonly known as fibroids, are the most prevalent benign tumors in women of reproductive age and a major contributor to gynecological morbidity. Although surgery and hormonal therapies are standard treatments, their associated side effects have prompted the search for safer, non-hormonal alternatives. Oligo-fucoidan, a sulfated polysaccharide derived from brown seaweed, has demonstrated anti-fibrotic and estrogen-regulating effects in preclinical models, but its clinical potential remains largely unexplored. Methods: In this randomized, double-blind, placebo-controlled pilot trial, 16 women diagnosed with uterine leiomyomas by ultrasound were enrolled and randomly assigned to receive either oligo-fucoidan (4 g/day) or placebo for six months (n = 8 per group). The primary endpoints were changes in the number of leiomyomas and quality of life, assessed using the World Health Organization Quality-of-Life Scale (WHOQOL-BREF) and Menstrual Distress Questionnaire (MDQ). Hormonal and safety parameters were also monitored. Results: Compared with the placebo group, participants receiving oligo-fucoidan exhibited a statistically significant reduction in fibroid number and reported improvements in quality-of-life domains. No serious adverse events occurred, and no clinically significant changes were noted in safety-related laboratory parameters. Conclusions: This pilot study provides preliminary clinical evidence that oligo-fucoidan may be a safe, well-tolerated, and potentially effective functional food-based approach for managing uterine fibroids. Larger trials are warranted to confirm these findings. Full article

Background/Objectives: Beyond the core characteristics of the condition, autistic individuals often significantly struggle with postural balance. This pilot study aimed to investigate the effects of an immersive virtual reality-based training administered with Gait Real-time Analysis Interactive Lab (GRAIL) on postural balance of autistic children. Methods: A total of 20 autistic participants aged 6 to 13 were enrolled in a 5-week randomized, parallel-group, open-label, controlled trial, and received either balance training with the GRAIL system or no training. The trial was registered at ClinicalTrials.gov (identifier: NCT04276571). The primary outcome measures were the change in center of pressure (CoP) metrics during GRAIL balance assessments and the change in motor skills as assessed with Movement Assessment Battery for Children-2. Secondary outcome measures included parent-report Developmental Coordination Disorder Questionnaire, center of mass metrics, and gait parameters evaluated with GRAIL. ANCOVA tests were performed for all outcomes, with time (T0 and T1) as within-subjects factor, the group (training and control groups) as between-subjects factor, and considering age as covariate. Results: Slight but significant time by group interactions were found in some CoP metrics (i.e., sway path length, velocity in the antero-posterior direction, and the jerk). Conclusions: These findings preliminarily suggest that a virtual reality-based training may induce slight modifications in postural balance strategies, which can be enhanced with longer or more intensive training. Full article

Background: Chronic wounds are a growing clinical challenge due to their prolonged healing time and associated healthcare burden. Combined therapeutic approaches, including topical oxygen therapy (TOT) and negative-pressure wound therapy (NPWT), have shown promise in enhancing wound healing. This pilot exploratory study aimed to assess the clinical effectiveness of combined TOT and NPWT in chronic wound treatment and to explore the prognostic value of selected laboratory and thermographic markers. Methods: Eighteen patients with chronic wounds due to type 2 diabetes mellitus or chronic venous insufficiency were treated with either TOT alone (control group) or TOT combined with NPWT (intervention group). Wound characteristics, thermographic data, and laboratory parameters (NLR, MLR, PLR, CRP, and total protein) were collected at baseline and during therapy. The primary endpoints were the total treatment duration and complete wound closure. Statistical analyses were exploratory and used non-parametric tests, correlation analyses, and simple linear regression. Results: Ulcer duration was significantly associated with the wound surface area. Lower serum total protein levels correlated negatively with ulcer duration, wound size, and granulation tissue area. A significant reduction in treatment duration was observed in the intervention group compared to the controls. One strong correlation was found between MLR and peripheral wound temperature on day 7 in the control group. No significant group differences were observed in wound size or thermographic measures after one week of treatment. Conclusions: Combining TOT and NPWT may reduce treatment duration in chronic wound management. Selected laboratory and thermographic markers show promise as prognostic tools. These exploratory findings require confirmation in larger, randomized trials. Full article

Background/Objectives: Conventional ketogenic diets, although effective for weight loss, often contain high total and saturated fat intake, which leads to increased low-density lipoprotein cholesterol (LDL-C). Thus, the Healthy Ketogenic Diet (HKD) was developed to address these concerns. It emphasizes calorie restriction, limiting net carbohydrate intake to 50 g per day, prioritizing unsaturated fats, and reducing saturated fat intake. However, adherence to the HKD remains a challenge in urban, time-constrained environments. Therefore, this pilot randomized controlled trial aimed to investigate the effects of Healthy Ketogenic Diet Ready-To-Eat (HKD-RTE) meals (provided for the first month only) versus HKD alone on weight loss and metabolic parameters among overweight adults. Methods: Multi-ethnic Asian adults (n = 50) with a body mass index (BMI) ≥ 27.5 kg/m² were randomized into the HKD-RTE group (n = 24) and the HKD group (n = 26). Both groups followed the HKD for six months, with the HKD-RTE group receiving HKD-RTE meals during the first month. Five in-person workshops and mobile health coaching through the Nutritionist Buddy Keto app helped to facilitate dietary adherence. The primary outcome was the change in body weight at 6 months. Linear regression was performed on the change from baseline for each continuous outcome, adjusting for demographics and relevant covariates. Logistic regression was performed on binary weight loss ≥ 5%, adjusting for demographics and relevant covariates. Results: In the HKD group, participants’ adherence to the 50 g net carbohydrate target was 15 days, while that in the HKD-RTE group was 19 days over a period of 30 days. Participants’ adherence to calorie targets was 21 days in the HKD group and 23 days in the HKD-RTE. The average compliance with the HKD-RTE meals provided in the HKD-RTE group was 55%. The HKD-RTE group experienced a greater percentage weight loss at 1 month (−4.8 ± 3.0% vs. −1.8 ± 6.2%), although this was not statistically significant. This trend continued up to 6 months, with the HKD-RTE group showing a greater percentage weight reduction (−8.6 ± 6.8% vs. −3.9 ± 8.6%; p = 0.092). At 6 months, the HKD-RTE group had a greater reduction in total cholesterol (−0.54 ± 0.76 mmol/L vs. −0.05 ± 0.56 mmol/L; p = 0.283) and LDL-C (−0.43 ± 0.67 mmol/L vs. −0.03 ± 0.52 mmol/L; p = 0.374) compared to the HKD group. Additionally, the HKD-RTE group exhibited greater reductions in systolic blood pressure (−8.3 ± 9.7 mmHg vs. −5.3 ± 11.0 mmHg), diastolic blood pressure (−7.7 ± 8.8 mmHg vs. −2.0 ± 7.0 mmHg), and HbA1c (−0.3 ± 0.5% vs. −0.1 ± 0.4%) than the HKD group (not statistically significant for any). Conclusions: Both HKD-RTE and HKD led to weight loss and improved metabolic profiles. The HKD-RTE group tended to show more favorable outcomes. Short-term HKD-RTE meal provision may enhance initial weight loss, with sustained long-term effects. Full article