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Recent research has begun to identify the neural mechanisms underlying the beneficial impact of mindfulness meditation training (MMT) on health and cognition. However, little is known about the effects of MMT on the global interplay of large-scale networks (LSNs) in the brain. In the present study, healthy, meditation-naïve adults ( N  = 46) underwent resting state fMRI prior to and upon completing 31 days of MMT or an active control intervention. Independent component analysis, sliding time window, and seed-based correlation analyses were performed to assess training-related changes in functional connectivity (FC) within and between networks with relevance to mindfulness meditation. Across sliding time window analyses and seed-based correlation analyses, we found increased FC between nodes of the default mode network (DMN) and nodes of the salience network (SN) in participants of the MMT. Seed-based correlation analyses revealed further connectivity increases between the SN and key regions of the central executive network (CEN). These results indicate, that, among multiple LSNs, one month of mindfulness meditation effectively increases interconnectivity between networks of the triple network model (DMN, SN, CEN), hereby introducing a potential mechanistic concept underlying the beneficial impact of MMT. Clinical trial registration: This study is listed as a clinical trial on the ISRCTN registry with trial ID ISRCTN95197731 (date of first registration: 15/02/2022).

This study aimed to validate a wearable device’s walking speed estimation pipeline, considering complexity, speed, and walking bout duration. The goal was to provide recommendations on the use of wearable devices for real-world mobility analysis. Participants with Parkinson’s Disease, Multiple Sclerosis, Proximal Femoral Fracture, Chronic Obstructive Pulmonary Disease, Congestive Heart Failure, and healthy older adults (n = 97) were monitored in the laboratory and the real-world (2.5 h), using a lower back wearable device. Two walking speed estimation pipelines were validated across 4408/1298 (2.5 h/laboratory) detected walking bouts, compared to 4620/1365 bouts detected by a multi-sensor reference system. In the laboratory, the mean absolute error (MAE) and mean relative error (MRE) for walking speed estimation ranged from 0.06 to 0.12 m/s and − 2.1 to 14.4%, with ICCs (Intraclass correlation coefficients) between good (0.79) and excellent (0.91). Real-world MAE ranged from 0.09 to 0.13, MARE from 1.3 to 22.7%, with ICCs indicating moderate (0.57) to good (0.88) agreement. Lower errors were observed for cohorts without major gait impairments, less complex tasks, and longer walking bouts. The analytical pipelines demonstrated moderate to good accuracy in estimating walking speed. Accuracy depended on confounding factors, emphasizing the need for robust technical validation before clinical application. Trial registration : ISRCTN – 12246987.

The main objective of this study is to analyze the clinical efficacy of telerehabilitation in the recovery of Long COVID patients through ReCOVery APP for 3 months, administered in the Primary Health Care context. The second objective is to identify significant models associated with an improvement in the study variables. An open-label randomized clinical trial was conducted using two parallel groups of a total of 100 Long COVID patients. The first group follows the treatment as usual methods established by their general practitioner (control group) and the second follows the same methods and also uses ReCOVery APP (intervention group). After the intervention, no significant differences were found in favour of the group intervention. Regarding adherence, 25% of the participants made significant use of the APP. Linear regression model establishes that the time of use of ReCOVery APP predicts an improvement in physical function (b = 0.001; p  = 0.005) and community social support (b = 0.004; p  = 0.021). In addition, an increase in self-efficacy and health literacy also contribute to improving cognitive function (b = 0.346; p  = 0.001) and reducing the number of symptoms (b = 0.226; p  = 0.002), respectively. In conclusion, the significant use of ReCOVery APP can contribute to the recovery of Long COVID patients. Trial Registration No.: ISRCTN91104012.

Background Pilot and feasibility studies provide information to be used when planning a full trial. A sufficient sample size within the pilot/feasibility study is required so this information can be extracted with suitable precision. This work builds upon previous reviews of pilot and feasibility studies to evaluate whether the target sample size aligns with recent recommendations and whether these targets are being reached. Methods A review of the ISRCTN registry was completed using the keywords “pilot” and “feasibility”. The inclusion criteria were UK-based randomised interventional trials that started between 2013 (end of the previous review) and 2020. Target sample size, actual sample size and key design characteristics were extracted. Descriptive statistics were used to present sample sizes overall and by key characteristics. Results In total, 761 studies were included in the review of which 448 (59%) were labelled feasibility studies, 244 (32%) pilot studies and 69 (9%) described as both pilot and feasibility studies. Over all included pilot and feasibility studies ( n  = 761), the median target sample size was 30 (IQR 20–50). This was consistent when split by those labelled as a pilot or feasibility study. Slightly larger sample sizes (median = 33, IQR 20–50) were shown for those labelled both pilot and feasibility ( n  = 69). Studies with a continuous outcome ( n  = 592) had a median target sample size of 30 (IQR 20–43) whereas, in line with recommendations, this was larger for those with binary outcomes (median = 50, IQR 25–81, n  = 97). There was no descriptive difference in the target sample size based on funder type. In studies where the achieved sample size was available ( n  = 301), 173 (57%) did not reach their sample size target; however, the median difference between the target and actual sample sizes was small at just minus four participants (IQR −25–0). Conclusions Target sample sizes for pilot and feasibility studies have remained constant since the last review in 2013. Most studies in the review satisfy the earlier and more lenient recommendations however do not satisfy the most recent largest recommendation. Additionally, most studies did not reach their target sample size meaning the information collected may not be sufficient to estimate the required parameters for future definitive randomised controlled trials.

Stress-related overeating can lead to excessive weight gain, increasing the risk of metabolic and cardiovascular disease. Mindfulness meditation has been demonstrated to reduce stress and increase interoceptive awareness and could, therefore, be an effective intervention for stress-related overeating behavior. To investigate the effects of mindfulness meditation on stress-eating behavior, meditation-naïve individuals with a tendency to stress-eat ( N  = 66) participated in either a 31-day, web-based mindfulness meditation training or a health training condition. Behavioral and resting-state fMRI data were acquired before and after the intervention. Mindfulness meditation training, in comparison to health training, was found to significantly increase mindfulness while simultaneously reducing stress- and emotional-eating tendencies as well as food cravings. These behavioral results were accompanied by functional connectivity changes between the hypothalamus, reward regions, and several areas of the default mode network in addition to changes observed between the insula and somatosensory areas. Additional changes between seed regions (i.e., hypothalamus and insula) and brain areas attributed to emotion regulation, awareness, attention, and sensory integration were observed. Notably, these changes in functional connectivity correlated with behavioral changes, thereby providing insight into the underlying neural mechanisms of the effects of mindfulness on stress-eating. Clinical trial on the ISRCTN registry: trial ID ISRCTN12901054

Endurance running is well-documented to affect health beneficially. However, data are still conflicting in terms of which race distance is associated with the maximum health effects to be obtained. Therefore, the aim of this study was to compare the health status of endurance runners over different race distances. A total of 245 recreational runners (141 females, 104 males) completed an online survey. Health status was assessed by measuring eight dimensions in two clusters of health-related indicators (e.g., body weight, mental health, chronic diseases and hypersensitivity reactions, medication intake) and health-related behaviors (e.g., smoking habits, supplement intake, food choice, healthcare utilization). Each dimension consisted of analytical parameters derived to a general domain score between 0 and 1. Data analysis was performed by using non-parametric ANOVA and MANOVA. There were 89 half-marathon (HM), 65 marathon/ultra-marathon (M/UM), and 91 10-km runners. 10-km runners were leaner than both the HM and M/UM runners ( p  ≤ 0.05). HM runners had higher health scores for six dimensions (body weight, mental health, chronic diseases and hypersensitivity reactions, medication intake, smoking habits, and health care utilization), which contributed to an average score of 77.1% (score range 62–88%) for their overall state of health. Whereas 10-km and M/UM runners had lesser but similar average scores in the overall state of health (71.7% and 72%, respectively). Race distance had a significant association with the dimension “chronic diseases and hypersensitivity reactions” ( p  ≤ 0.05). Despite the null significant associations between race distance and seven (out of eight) multi-item health dimensions, a tendency towards better health status (assessed by domain scores of health) among HM runners was found compared to other distance runners. However, the optimal state of health across all race distances supported the notion that endurance running contributed to overall health and well-being. Trial registration number: ISRCTN73074080. Retrospectively registered 12th June 2015.

PurposeLow fruit and vegetable consumption is linked with an increased risk of death from vascular disease and cancer. The benefit of eating fruits and vegetables is attributed in part to antioxidants, vitamins and phytochemicals. Whether increasing intake impacts on markers of disease remains to be established. This study investigates whether increasing daily intake of fruits, vegetables and juices from low (approx. 3 portions), to high intakes (approx. 8 portions) impacts on nutritional and clinical biomarkers. Barriers to achieving the recommended fruit and vegetable intakes are also investigated.MethodIn a randomised clinical trial, the participants [19 men and 26 women (39–58 years)] with low reported fruit, juice and vegetable intake (<3 portions/day) were randomised to consume either their usual diet or a diet supplemented with an additional 480 g of fruit and vegetables and fruit juice (300 ml) daily for 12 weeks. Nutritional biomarkers (vitamin C, carotenoids, B vitamins), antioxidant capacity and genomic stability were measured pre-intervention, at 4-, 8- and 12 weeks throughout the intervention. Samples were also taken post-intervention after a 6-week washout period. Glucose, homocysteine, lipids, blood pressure, weight and arterial stiffness were also measured. Intake of fruit, fruit juice and vegetables was reassessed 12 months after conducting the study and a questionnaire was developed to identify barriers to healthy eating.ResultsIntake increased significantly in the intervention group compared to controls, achieving 8.4 portions/day after 12 weeks. Plasma vitamin C (35%), folate (15%) and certain carotenoids [α-carotene (50%) and β-carotene (70%) and lutein/zeaxanthin (70%)] were significantly increased (P < 0.05) in the intervention group. There were no significant changes in antioxidant capacity, DNA damage and markers of vascular health. Barriers to achieving recommended intakes of fruits and vegetables measured 12 months after the intervention period were amount, inconvenience and cost.ConclusionWhile increasing fruit, juice and vegetable consumption increases circulating level of beneficial nutrients in healthy subjects, a 12-week intervention was not associated with effects on antioxidant status or lymphocyte DNA damage.Trial registrationThis trial was registered at Controlled-Trials.com; registration ISRCTN71368072.

Pectus excavatum (PE) is a congenital malformation with a funnel-shaped depression of the sternum that can lead to cardiac symptoms. However, there are patients with thoracic constriction (defined as elevated Haller-Index > 3.25 determined by cardiac magnetic resonance imaging (CMR)) without visible evidence of PE, leading to similar complaints. Between January 2004 till June 2020, patients who underwent CMR for further evaluation of the heart, due to cardiac symptoms were enrolled and compared to controls. Biventricular global strain analysis was assessed using feature tracking (CMR-FT). ECG and/or Holter recordings were performed to detect rhythm events. Cardiac symptoms were evaluated in detail using a questionnaire. Finally, 88 patients (male 35, female 53) with elevated Haller-Index (3.9 ± 0.8) were included and compared to CMR data from 25 individuals with confirmed PE and 25 healthy controls (HC). Mean age at time of CMR was 35 ± 16 years. The most common symptoms at presentation were palpitations (41%), followed by dyspnea (24%) and atypical chest pain (14%). Three patients (3%) had atrial fibrillation or atrial flutter. Concomitant phenomena were pericardial effusion in 39% and mitral valve prolapse (MVP) in 27% of the study cohort. While there were no differences in left ventricular function or volumes, right ventricular function (RVEF) was significantly lower in patients with internal PE compared to HC (RVEF (%) 50 ± 5 vs 59 ± 4, p < 0.01). Strain analysis revealed only discrete changes in RV strain, implying a purely mechanical problem in the absence of structural changes. RV dimensions were negatively correlated with the size of thoracic indices (r = 0.41), reflecting the extent of thoracic constriction. MVP was more prevalent in patients with greater thoracic indices (r = 0.24). The described cohort, referred to as internal PE because of the absence of external changes, showed similar CMR morphologic findings as patients with real PE (especially altered dimensions of the right heart and a lower RVEF). In addition, there was a high incidence of rhythm disturbances, such as extrasystoles or arrhythmias. In one-third of the study cohort additional abnormalities such as pericardial effusion or MVP were present, with MVP being found more frequently in patients with larger thoracic indices, suggesting a possible common pathogenesis. Trial registration: ISRCTN registry, ISRCTN15355937, retrospectively registered 03.06.2022, https://www.isrctn.com/ISRCTN15355937?q=15355937&filters=&sort=&offset=1&totalResults=1&page=1&pageSize=10 .

BackgroundArtificial intelligence ultrasound of prostate (AIUSP)-targeted biopsy has been used for prostate cancer (PCa) diagnosis. The objective of this prospective multi-center head-to-head clinical randomized comparative trail (RCT) is to compare PCa detection rate in the TRUS-guided 12-core standard systematic biopsy (TRUS-SB) group and cognitive fused mpMRI-guided 12-core biopsy (mpMRI) group against AIUSP group.MethodsFour hundred patients were randomized to three arms and underwent biopsies by TRUS-SB (n = 133), mpMRI (n = 134), and AIUSP (n = 133) between January 2015 and December 2017. In TRUS-SB group, a standard 12-core systematic biopsy was performed. In mpMRI group, mpMRI-suspicious lesions (PI-RADS 3–5) were targeted by 2-core biopsy followed by a 10-core systematic biopsy. Otherwise, 12-core systematic biopsy was performed. In AIUSP group, a 6-core targeted biopsy was performed. The primary endpoint was PCa detection rate.ResultsAIUSP detected the highest rate of PCa (66/133, 49.6%) compared to TRUS-SB (46/133, 34.6%, p = 0.036) and mpMRI (48/134, 35.8%, p = 0.052). Compared to TRUS-SB (35/133, 26.3%) and mpMRI (31/134, 23.1%) groups, clinically significant PCa (csPCa) detection rate was 32.3% (43/133) in AIUSP group. Overall biopsy core positive rate in the TRUS-SB group (11.0%, 176/1598) and in the mpMRI group (12.7%, 204/1608) was significantly lower than that in the AIUSP group (22.7%, 181/798, p < 0.001).ConclusionsAIUSP detected the highest rate of overall and significant PCa compared to TRUS-SB and mpMRI, and could be used as an alternative to systematic biopsy in the future.RegistrationThis trial was registered in ISRCTN (ISRCTN18033113).

Purpose The aim was to investigate the measurement properties of the EQ-5D-5L utility index in patients after arthroscopic rotator cuff repair (RCR), total shoulder arthroplasty (TSA) or thumb carpometacarpal (CMC I) arthroplasty. Methods In this prospective study, all patients completed the EQ-5D-5L before surgery and 6 months and 1 year after surgery. In addition, RCR patients completed the Oxford Shoulder Score (OSS), TSA patients completed the Shoulder Pain and Disability Index (SPADI) and CMC I patients completed the brief Michigan Hand Outcomes Questionnaire (brief MHQ) at each designated time point. Construct validity (Pearson’s correlation coefficient, r), responsiveness (effect size), minimal important difference (MID), minimal important change (MIC), and floor and ceiling effects of the EQ-5D-5L were determined. To test discriminative ability, EQ-5D-5L utility indices of patients who were in a patient acceptable symptom state (PASS) or not at follow-up were compared using the Mann–Whitney U test. Results We included 153 RCR, 150 TSA, and 151 CMC I patients. The EQ-5D-5L utility index correlated with the OSS ( r  = 0.73), SPADI ( r  = − 0.65) and brief MHQ ( r  = 0.61). The effect sizes were 1.3 (RCR and CMC I group) and 1.1 (TSA). The MID and MIC ranged from 0.027 to 0.209. Ceiling effects were found. The EQ-5D-5L utility index differed significantly between patients being in a PASS versus patients who were not in a PASS. Conclusion The EQ-5D-5L utility index shows good construct validity, responsiveness and discriminative ability in patients after arthroscopic RCR, TSA and CMC I arthroplasty and is suitable to quantify quality of life. Clinical trial registration: This auxiliary analysis is part of a primary study that was originally registered at ClinicalTrials.gov (NCT01954433) on October 1, 2013.