Search Results (516)

Background: This systematic review evaluates the efficacy of rehabilitation-focused exercise interventions for lumbar degenerative disc disease (DDD), a leading cause of chronic low back pain. Methods: Following PRISMA guidelines, a comprehensive search was conducted across international and regional databases (PubMed, Scopus, Web of Science, Magiran, SID, and Noormags) covering the period from January 2010 to January 2025. The review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) under registration number CRD420251088811. Using keywords such as “lumbar DDD,” “exercise therapy,” and “rehabilitation,” a total of 2495 records were identified. After screening, 20 studies—including clinical trials, quasi-experimental, and experimental designs—met the inclusion criteria and were assessed using the McMaster Critical Review Form for Quantitative Studies. Results: Interventions such as hydrotherapy, core stability training, Pilates, and suspension exercises were found to significantly reduce pain and improve functional outcomes. While multimodal approaches (e.g., aquatic exercise combined with acupuncture) showed positive effects, the comparative studies revealed no significant differences between modalities. Suspension training demonstrated superior efficacy in pain reduction compared to isolated core stability exercises. The methodological quality of included studies ranged from good to excellent, with the majority rated as very good or excellent (McMaster scores: 8 “excellent,” 7 “very good,” and 5 “good”). Common limitations among the studies included methodological heterogeneity, small sample sizes (n = 14–30), and insufficient long-term follow-up. Conclusions: Exercise-based rehabilitation is an effective strategy for managing lumbar DDD. Evidence particularly supports the use of suspension training and aquatic therapy for superior improvements in pain and functional outcomes. Future research should aim to adopt standardized protocols, recruit larger sample sizes, and include extended follow-up periods to produce more robust and generalizable findings. Full article

Objective: This study aimed to investigate whether the subjective assessments of strong and weak muscles in the Functional Myodiagnosis muscle test (FMD-MT) can be objectively and reproducibly verified using physically measurable parameters. Additionally, we sought to evaluate the reliability of the manual muscle test in order to reinforce the scientific evidence supporting this accepted, yet not widely adopted, complementary medicine method. Methods: In a crossover observational study, three experienced medical practitioners conducted the FMD-MT of the rectus femoris muscle on 24 healthy participants using a specially designed therapy bench, with all measurements recorded via an oscillogram. The study investigated the force–time integral, joint angle change, additional force load, mean force turning point 1, as well as the interrater reliability and validity of both examiner assessments and instrumental analyses for the two muscle reaction variants: strong and weak. Results: A significant difference between the response pattern of strong and weak muscles was identified for the force–time integral (p = 0.005), the change in joint angle (p < 0.001), and the additional force load (p = 0.001). No difference between strong and weak muscles could be detected regarding the force turning point 1 (p = 0.972). The examiners demonstrated 100% accuracy in identifying weak muscle reactions as weak, and 99.2% accuracy in identifying strong muscle reactions as strong (p = 0.316). The overall intra-class correlation coefficient was 0.984. The oscillogram correctly visualized weak muscle reactions in weak muscles with an accuracy of 81.7%, and strong muscle reactions in strong muscles with an accuracy of 86.7% (p = 0.289). Conclusions: The Functional Myodiagnosis muscle test (FMD-MT) enables a clear and objective differentiation between strong and weak muscles, with statistically significant differences observed in the force–time integral, additional force load, and joint angle changes. Under rigorously standardized testing conditions, the FMD-MT of the rectus femoris muscle demonstrates a validity rate of 99.6% and an excellent reliability (ICC 0.984). Consequently, the FMD muscle test proves to be a reliable, reproducible, and objective diagnostic method. Trial registration: German Register of Clinical Studies U1111-1212-6622. Full article

Background/Objectives: This study aimed to compare the effects of low- and medium-frequency NMES, combined with a standard physical therapy (SPT) program, on functional capacity in critically ill patients. Methods: Fifty-four critically ill patients admitted into Intensive Care Unit (ICU) and on mechanical ventilation participated in this randomized, single-blinded, experimental study. Participants were randomly assigned to a Control group, who received a lower limb SPT program; the Low-frequency NMES group received lower limb SPT + NMES at 100 Hz; and the Medium-frequency NMES group received lower limb SPT + NMES at 100 Hz with a carrier frequency of 2500 Hz. The outcomes, encompassing functional capacity in the hospital, included muscle strength, handgrip strength, functional status, degree of independence for activities of daily living, functional and dynamic mobility, quality of life, and total days hospitalized. Results: Both NMES protocols combined with SPT improved functional capacity compared to the control group. Medium-frequency NMES provided additional benefits on dynamic balance, in the degree of independence to perform activities of daily living and quality of life (all p < 0.001) prior to hospital discharge. It also promoted larger gains on functional status prior to ICU discharge and on knee extension strength (both p < 0.05) prior to intermediate care unit discharge. Medium-frequency NMES also enhanced handgrip strength earlier than low-frequency NMES when compared to the control group. Notably, medium-frequency NMES was the only intervention associated with a significant reduction in total hospital stay duration (p < 0.05). Conclusions: Medium-frequency NMES, along with an SPT program in critically ill patients, showed greater benefits on functional capacity during recovery than low-frequency NMES. (Trial registration: This trial is registered on ClinicalTrials.gov: NCT05287919). Implications for rehabilitation: 1. Medium-frequency NMES may enhance physical functionality and quality of life in critically ill patients with ICU-acquired weakness. 2. Medium-frequency NMES can reduce the number of hospitalization days. 3. NMES combined with SPT represents a feasible and effective option for patients unable to engage in active rehabilitation during critical illness. Full article

Background/Objectives: This study aimed to assess real-world toxicity and efficacy data of patients with early and advanced breast cancer (BC) who received treatment with abemaciclib. Methods: This was a prospective/retrospective multi-institutional collection of clinicopathological, toxicity, and outcome data from patients with early or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative BC who received treatment with abemaciclib in combination with endocrine therapy in departments of oncology in Greece. Treatment combinations of abemaciclib with any endocrine therapy were accepted. The primary end point was toxicity rate in all patients of the study. Results: From June/2021 to May/2024, 245 women received abemaciclib/endocrine combination therapy; the median age was 57 years. Of these, 169 (69%) received abemaciclib as adjuvant therapy for early-stage disease, while 76 (31%) were treated for advanced BC. At the time of the data cutoff, 133 (84.7%) patients remained in the 2-year treatment period. The most common adverse event (AE) was diarrhea (51%), primarily Grade ≤ 2. Dose modifications due to AEs were required in 19.2% of cases, while treatment discontinuation occurred in 5.1%. There was no difference in dose modification/discontinuation rates between older patients (>65 years) and the remaining patients. For early-stage BC patients, the 2-year DFS and OS rates were 90.8% and 100%, respectively. In patients with advanced cancer (70, 30.8%), 1-year PFS and OS rates were 78% and 96.3%, respectively. Conclusions: This study confirms the safety and effectiveness of abemaciclib in alignment with registrational trials offering valuable insights into toxicity management and clinical outcomes in routine practice without identifying new safety concerns. Clinical Trial Registration: ClinicalTrials.gov NCT04985058. Full article

Background/Objectives: Anxiety before ophthalmic surgery under local anesthesia may hinder patient cooperation and surgical outcomes. Nurse-led auditory interventions offer a promising non-pharmacological approach to perioperative anxiety management. This study evaluated the effectiveness of superimposed binaural beats (SBBs)—classical music layered with frequency differentials—in reducing anxiety during pterygium surgery with conjunctival autografting. Methods: In this randomized controlled trial, 111 adult patients scheduled for elective pterygium excision with conjunctival autografting under local anesthesia were allocated to one of three groups: SBBs, plain music (PM), or silence (control). A trained perioperative nurse administered all auditory interventions. The patients’ anxiety was assessed using the State–Trait Anxiety Inventory—State (STAI-S), and physiological parameters (blood pressure, heart rate, respiratory rate, and oxygen saturation) were recorded before and after surgery. Results: The SBB group showed significantly greater reductions in their STAI-S scores (p < 0.001), systolic blood pressure (p = 0.011), heart rate (p = 0.003), and respiratory rate (p = 0.009) compared to the PM and control groups. No adverse events occurred. Conclusions: SBBs are a safe, nurse-delivered auditory intervention that significantly reduces perioperative anxiety and supports physiological stability. Their integration into routine nursing care for minor ophthalmic surgeries is both feasible and beneficial. Trial Registration: This study was registered with the Thai Clinical Trials Registry (TCTR) under registration number TCTR20250125002 on 25 January 2025. Full article

Background/Objectives: There is a need for randomized clinical trials with higher quality, especially for older people at high risk of falls, with interventions that consider individual needs, comprehensiveness of care, and connection with primary health care. We designed a randomized controlled trial to examine the effects of a case management intervention combined with a physical exercise protocol on risk factors for falls, falls data, adherence, satisfaction, costs, and implementation in community-dwelling older adults with high risk of falls. Methods: A minimum of 60 community-dwelling older people with high falls risk will participate in the randomized controlled assessor-blinded trial (MAGIC—v. 2). The trial will be conducted in a regional health department of São Paulo state (Brazil), which includes 6 cities. Participants will be randomized to the Intervention Group (case management intervention based on all individual risk factors for falls identified by a multidimensional assessment, over 16 weeks, once a week, by telephone calls). Both groups will perform a physical exercise protocol based on falls prevention for 16 weeks (twice a week) in Health Units. The assessment will be performed at baseline, after 16 weeks of intervention, after 6-month follow-up, and after 12-month follow-up. Primary outcome measures include falls data and potentially modifiable risk factors for falls. Discussion: This study has the potential to facilitate the future implementation of the intervention based on case management with a focus on fall prevention in the health sectors. Trial registration: Brazilian Registry of Clinical Trials (ReBEC). Full article

Introduction/Objective: Peritonitis remains a serious complication in patients undergoing automated peritoneal dialysis (APD), requiring prompt and effective antibiotic administration. This study evaluated whether delivering antibiotics directly through APD bags is as effective as administering them via an additional manual daytime exchange. Methods: We conducted a randomized, single-blind, non-inferiority clinical trial involving patients diagnosed with peritonitis. Participants were randomly assigned to receive Ceftazidime and Vancomycin, either via APD bags or through a combined approach of continuous ambulatory peritoneal dialysis (CAPD) plus APD. A total of 64 patients (32 per group) were enrolled, with comparable baseline demographic and clinical profiles, including laboratory markers of infection severity and dialysis history. Results: Peritonitis resolved in 90.6% of the patients treated via APD bags and in 81.3% of those receiving antibiotics through manual exchange plus APD. Although this difference did not reach statistical significance ($p$ = 0.281), the observed absolute difference of 9.3% was well within the predefined non-inferiority margin of 30%, supporting the clinical non-inferiority of the APD-only method. The mean time to resolution was similar between groups ($p$ = 0.593). Post hoc power analyses indicated limited statistical power (18.5% for the resolution rate and 9.2% for time to resolution), suggesting that modest differences may not have been detectable given the sample size. Nevertheless, the high resolution rates observed in both groups reflect valid and encouraging clinical outcomes. Conclusion: Antibiotic administration via APD bags demonstrated comparable clinical effectiveness to the combined manual exchange plus APD method for treating peritonitis. Given its operational simplicity and favorable results, the APD-only strategy may offer a pragmatic alternative in routine care. Further studies with larger sample sizes are recommended to confirm these findings and optimize treatment protocols. Trial registration: NCT04077996. Funding source: None to declare. Full article

Background/Objectives: Semaglutide, a glucagon-like peptide-1 receptor (GLP-1R) agonist, is a well-established pharmacologic agent for inducing weight loss in individuals with obesity and is prescribed regardless of type 2 diabetes mellitus (DM) status. However, it remains unclear whether the weight-lowering efficacy of semaglutide differs significantly between individuals with and without DM. To address this question, we conducted a systematic review and meta-analysis comparing the effects of once-weekly subcutaneous semaglutide at 2.4 mg on weight loss in adults with and without DM. Methods: A comprehensive literature search was performed using the PubMed database to identify randomized controlled trials (RCTs) involving overweight or obese adults receiving semaglutide at 2.4 mg weekly for 40 to 70 weeks. Using a random-effects model, we estimated the weighted mean differences in body weight reduction between the two groups. Nine RCTs met the inclusion criteria, among which two provided subgroup data for participants with and without DM within the same trial population. Registration number in PROSPERO: CRD420251077610. Results: In participants with DM (n = 4 studies), semaglutide was associated with a weighted mean body weight reduction of −6.34% (95% confidence interval: −6.98 to −5.69), with negligible heterogeneity across studies (I² = 0.0%). By contrast, among participants without DM (n = 7 studies), the weighted estimate of weight loss was −11.57% (95% confidence interval: −12.94 to −10.19), with moderate heterogeneity observed (I² = 63.6%). Conclusions: The observed difference in weight loss efficacy between the groups was clinically meaningful. While once-weekly semaglutide at 2.4 mg elicited significant weight loss in both populations, the magnitude of effect was notably greater in those without DM. This disparity may be explained by metabolic characteristics frequently present in individuals with DM, such as insulin resistance, hyperinsulinemia, and compensatory mechanisms related to glycemic control. Full article

Background: Endometrial cancer (EC) is the most common gynecological malignancy, increasingly affecting premenopausal women. While hysterectomy is the standard treatment, it eliminates reproductive potential, highlighting the need for effective fertility-sparing alternatives. Current ESHRE/ESGO/ESGE guidelines recommend progestin-based therapies, often with hysteroscopic resection. However, these are based on limited pharmacological options and moderate to low-quality evidence. Novel and combination therapies have shown promise but remain absent from current clinical guidelines. This review aims to evaluate the efficacy and safety of fertility-preserving treatments for early-stage EC, emphasizing the need to update current strategies based on emerging data. Methods: A systematic review and meta-analysis will follow PRISMA guidelines and the Cochrane Handbook. Eligible studies, including randomized and non-randomized designs, will assess fertility-preserving treatments for early-stage EC. Data will be extracted on complete response, recurrence, and long-term fertility outcomes. The GRADE system will assess evidence certainty. Risk of bias will be evaluated using RoB 2 for RCTs and ROBINS-I for non-randomized studies. Meta-analysis will be performed if sufficient data are available. Conclusions: This review will provide a comprehensive analysis of fertility-sparing treatments for early-stage EC, support personalized strategies, identify evidence gaps, and guide future research. Trial registration—Prospero: CRD420251032161. Full article

Long-acting (LA) antiretroviral therapies for human immunodeficiency virus (HIV), such as injectable formulations of cabotegravir and rilpivirine (CAB+RPV LA), are now available. Considering the limited data on the out-of-hospital administration of this combination, evaluating the implementation strategies needed is essential to support future clinical efforts. To gather data on barriers and facilitators of implementation for CAB+RPV LA in alternative outpatient facilities, this study used qualitative interviews informed by the Consolidated Framework for Implementation Research (CFIR), with 13 staff participating in the HOLA study (NCT06185452). Data analysis followed qualitative descriptive methods, assisted by Atlas.ti software version 22. The study adhered to the COREQ guidelines. Findings reveal five main factors to consider for implementation: operational and infrastructure adaptations, integrated management of human and organizational resources, need for coordination and follow-up, professional attitudes and work environment, and patient experience and patients’ needs perceived by professionals. This study emphasizes the comprehensive operational and infrastructure adaptations, adequate staff training, and supportive professional environment required for the successful implementation of CAB+RPV LA, while considering patients’ needs throughout the externalization process (trial registration number: NCT06643897). Full article

Background/Objectives: The effects of combining chemotherapy with hormonal therapy based on hormone receptor (HR) expression in epithelial ovarian, fallopian tube, or primary peritoneal (EOC) remain unclear. This study evaluated the efficacy and safety of physician-chosen chemotherapy combined with hormonal therapy in patients with heavily pretreated advanced EOC, stratified by HR expression. Methods: This phase II, multicenter, pilot study included patients with heavily pretreated advanced EOC, allocated to estrogen receptor (ER)-dominant or progesterone receptor (PR)-dominant arms. Patients in the ER-dominant arm received tamoxifen plus physician-selected chemotherapy, while those in the PR-dominant arm received megestrol acetate (MA) plus chemotherapy. The primary outcome was the best objective response rate (ORR) for six months, assessed using an optimal two-stage Simon design. Results: Among 33 ER-dominant patients with high-grade serous carcinoma (HGSC), the six-month best ORR was 27.3% (3% complete response, 24.2% partial response). The six-month ORR and clinical benefit rate (CBR) were 18.8% and 37.5%, respectively, with 62.5% experiencing progressive disease (PD). Among three PR-dominant patients (two clear cell carcinoma and one HGSC), the six-month best ORR was 0%. The six-month ORR and CBR were also 0%, and all experienced PD within six months. No unacceptable toxicity related to tamoxifen or MA was encountered. Conclusions: In heavily pretreated advanced HGSC patients with ER-dominant expression, chemotherapy combined with tamoxifen showed encouraging clinical activity with favorable safety. While limited by the study design, these findings suggest a potential role for tailored hormonal therapy combined with chemotherapy based on HR expression in heavily pretreated advanced EOC. Clinical Trial Registration: KCT0004571 Full article

Background: This study aimed to evaluate the changes in fat utilization associated with transitioning from a traditional to a vegan Mediterranean diet in healthy, physically active men during a ramp exercise test. Methods: In a controlled crossover design, fourteen healthy, physically active men followed a traditional Mediterranean diet for three weeks (baseline). Then, participants transitioned to a four-week isocaloric vegan version of the Mediterranean diet, matched for macronutrient distribution but excluding all animal foods. Immediately after each dietary intervention, participants completed an incremental exercise test (from 30% to 70% of VO_2peak) on a cycle ergometer in a fasted state to determine peak fat oxidation (PFO) and its associated exercise intensity (Fatmax). Exercise heart rate and the rating of perceived exertion were also recorded at each exercise intensity. Results: The traditional and vegan Mediterranean diets provided comparable amounts of energy (2599.6 ± 180.8 and 2634.9 ± 148.3 kcal/day, p = 0.140) and total fat (97.0 ± 17.8 and 99.0 ± 13.2 g/day; p = 0.620). However, the vegan Mediterranean diet contained a lower proportion of saturated fat (25.2 ± 6.8 vs. 13.6 ± 4.4% of total fat, p < 0.010). Still, the dietary transition was not associated with modifications in PFO (0.323 ± 0.153 and 0.347 ± 0.147 g/min; p = 0.678) or Fatmax (40.51 ± 7.30 and 40.51 ± 10.71%VO_2peak; p = 1.000) during exercise. Moreover, the dietary transition did not significantly change the response curves across exercise intensities for fat oxidation (p = 0.553), heart rate (p = 0.280), or the rating of perceived exertion (p = 0.433). Conclusions: Switching from a traditional to a vegan Mediterranean diet did not affect fat oxidation, exercise intensity at peak fat oxidation, or perceptual responses during exercise in healthy, active men. These findings suggest that physically active individuals can adopt a vegan version of the Mediterranean diet without compromising fat utilization during submaximal aerobic exercise. Clinical Trial Registry: NCT06008886. Date of registration: 28 July 2023. Full article

Background/objectives: Racial and ethnic minority patients are underrepresented in cancer clinical trials (CCTs) and multilevel strategies are required to increase participation. This study describes barriers and facilitators to minority CCT participation alongside feedback on a multilevel intervention (MLI) designed to reduce participation barriers, as posited by the socioecological model (SEM). Methods: Interviews with Moffitt Cancer Center (MCC) physicians, community physicians, patients with cancer, community residents, and clinical research coordinators (CRCs) were conducted from June 2023–February 2024. Verbal responses were analyzed using thematic analysis and categorized into SEM levels. Mean helpfulness scores rating interventions (from 1 (not helpful) to 5 (very helpful)) were summarized. Results: Approximately 50 interviews were completed. Thematic findings confirmed CCT referral and enrollment barriers across all SEM levels. At the community level, MCC patients and community residents felt that community health educators can improve patient experiences and suggested they connect patients to social/financial resources, assist with patient registration, and provide CCT education. While physicians and CRCs reacted positively to all institutional-level tools, the highest scored tool simultaneously addressed CCT referral and enrollment at the institution (e.g., trial identification/referrals) and interpersonal level (communication platform for community and MCC physicians) (mean = 4.27). At the intrapersonal level, patients were enthusiastic about a digital CCT decision aid (mean = 4.53) and suggested its integration into MCC’s patient portal. Conclusions: Results underscore the value of conducting formative research to tailor interventions to target population needs. Our approach can be leveraged by future researchers seeking to evaluate MLIs addressing additional CCT challenges or broader health topics. Full article

Background: Obesity is a global health challenge associated with metabolic and cardiovascular diseases. Traditional Chinese Medicine (TCM) body constitution theory offers a unique perspective on individual susceptibility to obesity; however, its integration into public health strategies remains underexplored. Objective: To examine the associations between vegetarian dietary patterns, TCM body constitution types (Phlegm stasis, Yang deficiency, and Yin deficiency), and overweight/obesity in a large-scale national cohort. Methods: Data were obtained from 3597 participants enrolled in the Taiwan Biobank. Socio-demographic variables, lifestyle behaviors (diet, smoking, physical activity), and anthropometric indicators (BMI and waist circumference) were assessed. Participants were categorized by weight status and TCM body constitution. Polytomous logistic regression models were used to evaluate associations between vegetarian dietary patterns, constitution types, and overweight/obesity, adjusting for potential confounders. Results: Among participants (mean age, 50.1 ± 9.4 years), 55.6% had normal BMI, 27.3% were overweight, and 17.1% were obese. Vegetarian dietary patterns were significantly associated with lower odds of Phlegm stasis (OR: 0.96; p < 0.001), Yang deficiency (OR: 0.97; p < 0.001), and Yin deficiency (OR: 0.97; p < 0.001), as well as with lower odds of overweight (OR: 0.72; p < 0.05) and obesity (OR: 0.67; p < 0.05). Physical activity was also associated with lower odds of all three constitution types and obesity. Phlegm stasis constitution was associated with higher odds of obesity (range of ORs: 1.18–1.58; p < 0.001). Conclusions: Vegetarian dietary patterns and regular physical activity were associated with lower odds of obesity and TCM constitution imbalances, particularly Phlegm stasis. These findings suggest a potential role for constitution-informed strategies in obesity-related public health approaches. Longitudinal studies are warranted to clarify temporal relationships and mechanisms. Clinical Trials Registration: ClinicalTrials.gov NCT03938207 (Study Start: 1 October 2022). Full article

Background: Metabolic bariatric surgery is a highly effective and long-lasting treatment for obesity and related chronic conditions. Women of reproductive age represent the largest group undergoing these procedures. Observational studies suggest an increased risk of preterm birth and impaired foetal growth in this population, though the underlying mechanisms remain unclear. A key hypothesis is that altered glucose metabolism, characterised by frequent hypoglycaemia and glycaemic fluctuations, may contribute to these adverse outcomes. While glycaemic variability following metabolic bariatric surgery has been documented, its pattern during pregnancy and impact on pregnancy outcomes are still underexplored. Methods: In this Belgian multicentre prospective cohort study, we will investigate glycaemic patterns during pregnancy in women who have undergone metabolic bariatric surgery. Women aged 18–45 years with a confirmed singleton pregnancy up to 11 weeks and 6 days and a history of Roux-en-Y gastric bypass or sleeve gastrectomy will be eligible for inclusion. Women with pregestational diabetes or those taking medication known to interfere with glucose metabolism will be excluded. All participants will receive blinded continuous glucose monitoring (Dexcom^® G6) for a 10-day period at four time points throughout the pregnancy. Foetal body composition and growth will be measured during routine ultrasound; skinfolds will be measured in the neonate. The primary outcome is the association between mean glycemia and glycaemic variability on continuous glucose monitoring and birth weight. The planned sample size is ninety-five women. Linear mixed models for repeated measurements will be used for analysis. Confounders such as smoking, micronutrient deficiency, and surgery-to-conception interval will be added to the model as covariates. In a second exploratory phase, each participant in the surgical group will be matched with a control participant—without a history of metabolic bariatric surgery—based on pre-pregnancy BMI and age. Control participants will undergo the same study procedures, allowing for exploratory comparison of glycaemic patterns and other study outcomes. Discussion: This prospective longitudinal study will be the largest study using continuous glucose monitoring to investigate glucose metabolism during pregnancy after metabolic bariatric surgery and its impact on foetal growth and newborn body composition. Trial registration: ClinicalTrials.gov: NCT05084339. Registration date: 15 October 2021. Full article