Parallel Intervention Research Articles

Parent-focused online video intervention for promoting parenting sense of competence: a randomized controlled trial.

Apart from child behavioral problems which were ameliorated by increasing parenting skills, parental well-being is one of the important components for development of parenting sense of competence (PSOC), which subsequently affects parenting style and child outcomes. This randomized controlled trial study aims to determine whether a brief asynchronous parent-focused online video intervention (POVI) that was easily accessible would be effective in increasing PSOC and parental well-being. One hundred and twenty parents, with a poor Thai Mental Health Indicators-15 score or mild-moderate depression/anxiety, of children aged 3-10 years, were randomized into two parallel groups, intervention and control groups (1:1). The intervention group received six online, weekly, parent-focused sessions. Parent and child outcomes were measured at baseline, 6, and 10 weeks. The Generalized Estimating Equations model was used for the analysis. At 10 weeks, the intervention group reported a higher PSOC (p = 0.005), particularly on the parenting satisfaction subscale, and mental health indicator. Both groups experienced reduced depression and anxiety from baseline, and child behaviors remained unchanged. POVI improved PSOC and parental well-being among parents with mild to moderate mental health problems. POVI may be used as a primary tool to promote parental well-being in general pediatric practice. This study demonstrates the efficacy of a parent-focused online video intervention (POVI) in enhancing parenting sense of competence and parental well-being. It addresses the gap in interventions that focus primarily on parental well-being, particularly for those who face mild to moderate mental health challenges. The findings contribute valuable insights for healthcare professionals, highlighting the potential of POVI, an easy-to-access and less time-consuming intervention, as a primary tool to promote parental well-being in general pediatric practice settings.

Improving Cognitive Empathy Through Traumatic Brain Injury Experiential Learning: A Novel Mixed Methods Approach for Speech-Language Pathology Graduate Education.

The aim of this study was to gauge the impacts of cognitive empathy training experiential learning on traumatic brain injury (TBI) knowledge, awareness, confidence, and empathy in a pilot study of speech-language pathology graduate students. A descriptive quasi-experimental convergent parallel mixed methods design intervention pilot study (QUAL + QUANT) was conducted with a diverse convenience sample of 19 first- and second-year speech-language pathology graduate students who engaged in a half-day TBI point-of-view simulation. The simulation was co-constructed through a participatory design with those living with TBI based on Kolb's experiential learning model and followed the recommendations for point-of-view simulation ethics. After setting goals, participants engaged in four station activities completing cognitive communication activities of daily living, while experiencing manipulations to their sensory systems. Activities included reading while wearing goggles with blurred or double vision, listening with tinnitus and auditory processing disorder, and taking notes during a manipulated college lecture. Participants also interacted with an individual living with TBI and responded to targeted prompts throughout the day. Quantitative outcomes were measured using published TBI knowledge and empathy scales and analyzed with descriptive, parametric and nonparametric statistics, while qualitative data were analyzed through thematic analysis. Data were then triangulated through mixed methods. Mixed methods design quality was ensured by following the Mixed Methods Appraisal Tool (Hong et al., 2018). After experiential learning, significant increases in speech-language pathologist (SLP) TBI knowledge, empathy, and awareness of TBI symptom and symptom impacts were found. Many, but not all, participants also reported changes in clinical confidence. Cognitive empathy training using experiential learning appears to be a viable method to increase SLP knowledge, empathy, and symptom awareness for TBI clinical care. Future research should replicate the study with different types and locations of speech-language pathology graduate programs to consider TBI empathy training as a standard training method to improve both individual and provider outcomes. Individuals and families living with traumatic brain injury (TBI) say their providers lack necessary knowledge; do not seem to understand what living with TBI is like; and can be dismissive, uncaring, and lacking empathy. Health care providers do not automatically imagine the world from the patient's perspectives, to "walk in another's shoes"; it takes intentional effort and training. This project attempted to train those specific empathy skills for speech-language pathology graduate students through experiential learning. Experiential learning is a process where people engage in meaningful activities and spend lots of time reflecting on their experiences. Working with people living with TBI, we built a half-day workshop where 19 graduate students completed normal daily activities (such as texting, reading) through different stations that provided insights into what it may be like to have a TBI, such as wearing goggles to induce blurred or double vision, having ringing in their ears (tinnitus), and watching an overwhelming manipulated college video lecture. Afterward, participants listened to a person living with TBI and asked questions. This was important because engaging in activities without interacting with someone living with TBI misses a key idea about listening to and learning from individuals and families. We measured TBI knowledge, empathy, and confidence by looking at surveys pre- and posttraining and reading students' written reflections. Participants reported significant changes in how they think about brain injury and how they will provide clinical care for people living with TBI in the future. https://doi.org/10.23641/asha.28098254.

Oral histidine affects gut microbiota and MAIT cells improving glycemic control in type 2 diabetes patients

ABSTRACT Amino acids, metabolized by host cells as well as commensal gut bacteria, have signaling effects on host metabolism. Oral supplementation of the essential amino acid histidine has been shown to exert metabolic benefits. To investigate whether dietary histidine aids glycemic control, we performed a case-controlled parallel clinical intervention study in participants with type 2 diabetes (T2D) and healthy controls. Participants received oral histidine for seven weeks. After 2 weeks of histidine supplementation, the microbiome was depleted by antibiotics to determine the microbial contribution to histidine metabolism. We assessed glycemic control, immunophenotyping of peripheral blood mononucelar cells (PBMC), DNA methylation of PBMCs and fecal gut microbiota composition. Histidine improves several markers of glycemic control, including postprandial glucose levels with a concordant increase in the proportion of MAIT cells after two weeks of histidine supplementation. The increase in MAIT cells was associated with changes in gut microbial pathways such as riboflavin biosynthesis and epigenetic changes in the amino acid transporter SLC7A5. Associations between the microbiome and MAIT cells were replicated in the MetaCardis cohort. We propose a conceptual framework for how oral histidine may affect MAIT cells via altered gut microbiota composition and SLC7A5 expression in MAIT cells directly and thereby influencing glycemic control. Future studies should focus on the role of flavin biosynthesis intermediates and SLC7A5 modulation in MAIT cells to modulate glycemic control.

Application of Honey and Transparent Dressing to Split Thickness Skin Graft Donor Site and Its Effect on Epithelialization Rate

Background: Split thickness skin graft (STSG) is one of the modalities used to close a defect. The donor site can be healed secondarily with tulle grass and moist gauze after 14 days and with transparent dressing will take about 10-13 days. Recently the wound healing by using honey application has been used. Whether or not using honey application with transparent dressing will hasten the epithelialization rate of the STSG donor site is now in question. Method: This research is an open, non-randomized clinical trial with a parallel design and intervention using honey application with transparent dressing. A total of 19 patients (7 female and 8 male) were included in this study. The reapplication of honey was done every two days. The patients was followed up every day, with clinical photograph taken and complaints such as pain, odor and infection noted. Results: The mean epithelialization rate of the donor site treated with honey and transparent dressing was 9,74 (+0,24) days compared to 10,79 (+1,23) days in the transparent-dressing-only group (p=0,00). Conclusion: The application of honey with transparent dressing to cover for STSG donor site led to a faster epithelialization rate, less odor and less pain. Commercial honey was used, and readily available.

Effectiveness of the community paramedicine at home (CP@home) program for frequent users of emergency medical services in Ontario: a randomized controlled trial

ObjectiveTo evaluate the impact of the Community Paramedicine at Home (CP@home) program, a community paramedicine home-visit intervention, on reducing emergency medical services (EMS) calls among frequent users.DesignA 6-month, open-label, pragmatic, randomized controlled trial with parallel intervention and control arms. An online automated platform (randomizer.org) was used to randomly allocate participants using a 1:1 allocation sequence.SettingIn homes of frequent EMS users in four paramedic services and regions across Ontario, Canada.ParticipantsEligible participants were frequent callers (≥ 3 EMS calls within six months and ≥ 1 EMS call within the previous month), or had ≥ 1 lift assist call within the previous month, or were referred by paramedics.InterventionCommunity paramedics conducted risk assessments, provided health education, referred appropriate resources, and reported to family physicians for up to three home visits. The control arm received usual care.Primary outcome measureEMS calls in 6 months during intervention.ResultsTwo thousand two hundred eighty four eligible participants were randomly allocated to the intervention and control groups, with 265 participants lost to follow-up due to inability to retrieve participant records from EMS databases. There were 1025 intervention participants (52.7% female, mean age 69.65 years [standard deviation (SD) = 19.98]) and 994 control participants (52.0% female, mean age 69.78 years [SD = 19.09]). In the post-intervention intention-to-treat analysis (zero-inflated negative binomial regression), the EMS call rate was not significantly lower in the intervention group compared to the control group (incidence rate ratio [IRR] = 0.88, 95% confidence interval [CI]: 0.76, 1.01). In the subgroup analysis, the intervention had a significant effect in the lift assist caller subgroup (IRR = 0.73, 95% CI: 0.58, 0.92), but no significant effect among the frequent caller subgroup (IRR = 0.97, 95% CI: 0.82, 1.14). The sensitivity analyses found a similar association for the lift assist caller subgroup. There was a significant subgroup effect (p-value for interaction < 0.01).ConclusionsCP@home had a significant impact on reducing EMS calls for those with a lift assist call but not for the overall sample. This program filled a healthcare gap by shifting primary care delivery, which could reduce the disproportionate number of EMS calls, thus reducing healthcare costs.Trial registrationRegistered with ClinicalTrials.gov NCT02835989 on July 14, 2016.

Registration and characteristics of clinical trials on traditional Chinese medicine and natural medicines for endometriosis: a comprehensive analysis.

To investigate the characteristics of clinical trials on traditional Chinese medicine (TCM) or natural medicines for treating endometriosis, aiming to inform future clinical practice and the development of new effective drugs. The global clinical trial registration platform was searched to identify clinical trials investigating the efficacy of TCM/natural medicine in treating endometriosis. Relevant trials were selected based on stringent inclusion and exclusion criteria. Data entry was performed using Microsoft Excel, while data analysis was conducted using SPSS version 23. The study encompassed 57 trials, of which ClinicalTrials.gov accounted for 18, ChiCTR for 3, ICRP for 15, and ChiDTR for 21 trials. The number of registrations showed a significant positive correlation with the years. Of the 57 clinical trials, 87.7% were randomized, 63.2% were blinded, 78.9% followed a parallel intervention model, and 56.1% had a sample size below 100. Regarding trial phases, 45.6% of clinical trials did not specify a phase, while Phase 3 and Phase 4 clinical trials accounted for 17.5%. Nine clinical trials involved drugs that are already on the market, including six Chinese patent medicines: Sanjie Zhentong Capsules, Honghua Ruyi Pills, Huayu Sanjie Enema Liquid, Kuntai Capsules, Wenjing Tang, and Xuefu Zhuyu Capsules. Outside China, Iran has the highest number of registrations for natural medicine treatments for endometriosis, with curcumin being the most registered natural medicine. The analysis reveals that clinical trials on TCM and natural remedies for endometriosis often utilize randomization; however, substantial deficiencies remain in blinding and sample size adequacy. These findings suggest that, despite growing interest in TCM and natural remedies, further methodological improvements are necessary to enhance the credibility of future studies. This research highlights the importance of rigorously designed clinical trials in verifying the safety and efficacy of these alternative therapies, which may influence future therapeutic approaches for managing endometriosis.

Safety and efficacy of personalised versus standard dosing of linezolid in patients with sepsis (SePkLin): a pragmatic, multicentre, randomised, controlled and superiority clinical trial protocol.

Linezolid is a broadly used antibiotic to treat complicated infections caused by gram-positive bacteria. Therapeutic drug monitoring of linezolid concentrations is recommended to maximise its efficacy and safety, mainly haematological toxicity. Different pharmacokinetic/pharmacodynamic targets have been proposed to improve linezolid exposure: the ratio of the area under the concentration-time curve during a 24-hour period to minimum inhibitory concentration (MIC) between 80 and 120; percentage of time that the drug concentration remains above the MIC during a dosing interval greater than 85% and the trough concentration between 2 and 7 mg/L. This clinical trial aims to evaluate the safety, efficacy and the clinical and economic utility of personalised dosing of linezolid using Bayesian forecasting methods to attain pharmacokinetic/pharmacodynamic targets, known as model-informed precision dosing. This is a pragmatic, multicentre, randomised, parallel, controlled, phase IV and low intervention trial. Participants will be randomly assigned 1:1 to each group (n=346 per group). Control group will receive the standard dose of linezolid. Intervention group will receive personalised dosage of linezolid based on pharmacokinetic-pharmacodynamic adjustments. The primary outcome will be the incidence of thrombocytopenia in both groups. This protocol was approved by the Ethical Committee of the Investigation with Medicines of Galicia (code 2022/140) and authorised by the Spanish Agency for Medicines and Medical Devices. The trial is implemented in accordance with the Declaration of Helsinki and the international ethical and scientific quality standard, the Good Clinical Practice. The results will be published in peer-reviewed journals. EudraCT registration code: 2022-000144-30.

Multi-objective optimization of inerter-based building mass dampers

The building mass damper (BMD) is a design concept in which a structure is substructured in such a way that the upper substructure behaves as a large-mass tuned mass damper for the lower one. Its correct tuning usually requires softening (partial isolating) the upper substructure, which limits its application for retrofitting. The recently proposed inerter-based building mass damper (IBMD) solves, reasonably, the softening dynamically through the use of an inerter. This implies an in parallel intervention, which drastically simplifies the practicability of the BMD for retrofitting. The present paper involves comprehensive numerical simulations for multi-objective optimization of an IBMD, accounting for inherent structural damping. In particular, the deformation of the upper substructure is an additional objective function, besides the deformation of the lower substructure as considered in a previous work. Results demonstrate that the IBMD outperforms various benchmark interventions, including dampers, stiffeners, softening devices, and inerters without dampers. Additionally, it was found that the inherent structural damping partially replaces the need for additional damping. Finally, it was also shown that emphasizing the optimization of the lower substructure deformation enhances the overall structural safety in most cases. Nevertheless, the multi-objective optimization increases the versatility of the design concept in the case of substructures with different allowable deformations.

Impact of a multimodal effort re-education programme on functionality, physical performance, and functional capacity in cancer patients with dyspnoea: a randomised experimental study

BackgroundIn recent years, there has been a significant increase in the survival rates of cancer patients. However, this has also led to an increase in side effects, such as dyspnoea, which can negatively impact of patients. We propose a programme for re-educating effort. The main objective is to test the effectiveness of this programme in improving respiratory symptoms and functionality in cancer patients.MethodologyExperimental, prospective, longitudinal, randomised study with a parallel fixed-assignment scheme (CG-IG). The patients were selected from the Medical Oncology Service of the University Hospital Complex of Salamanca (CAUSA), Spain. Two parallel intervention programmes were designed for the two study groups (Conventional Clinical Practice-Effort Re-education Programme). Primary variables: dyspnoea (MRC), functionality (Barthel); secondary variables: physical performance (SPPB) and functional capacity (ECOG) and the socio-demographic variables (age, sex, anatomopathological diagnosis, and number of treatment lines).ResultsThe study sample consisted of 182 patients, with 12 excluded, resulting in a final sample size of n = 170. Sex distribution (CG: 52.9% male and 47.1% female; IG: 49.4% male and 50.6% female). The primary oncological diagnosis was lung cancer, and the most frequent tumour stages were III and IV. Statistically significant differences were found between the IG and CG scores (p < 0.001, d = 0.887, 95% CI) and between the IG and CG scores (p = 0.004, d = 0.358, 95% CI), indicating that the IG performed better.ConclusionThe results of this study support the beneficial effects of an exercise re-education programme, carried out by an interdisciplinary team in improving the autonomy of oncology patients with dyspnoea.Trial registrationThe clinical trial was registered in ClinicalTrials.gov (NCT04186754). (03 September 2019).

Polyphenol-Rich Aronia melanocarpa Fruit Beneficially Impact Cholesterol, Glucose, and Serum and Gut Metabolites: A Randomized Clinical Trial.

Polyphenol-rich Aronia fruits have great potential as a functional food with anti-inflammatory, hypolipidemic, and hypoglycemic biologic activities. However, clinical intervention trials investigating the impact of Aronia fruit consumption on human health are limited. A randomized, controlled, double-blinded, parallel intervention trial was conducted using 14 human subjects who ingested either 0 mL or 100 mL of Aronia juice daily for 30 days. Anthropometric measurements, fasting, and postprandial measures of glucose and lipid metabolism and inflammation, 16S rRNA fecal microbial composition data, and mass spectrometry-acquired serum and fecal metabolomic data were collected before and after the intervention period. Data were analyzed using general linear models, ANOVA, and t-tests. Daily consumption of Aronia prevented a rise in cholesterol levels (β = -0.50, p = 0.03) and reduced postprandial glucose (β = -3.03, p < 0.01). No difference in microbial community composition by condition was identified at any taxonomic level, but a decrease (β = -18.2, p = 0.04) in microbial richness with Aronia was detected. Serum and fecal metabolomic profiles indicated shifts associated with central carbon and lipid metabolism and decreases in pro-inflammatory metabolites. Our study further informs the development of polyphenol-based dietary strategies to lower metabolic disease risk.

Effects of a Multifactorial Program with Case Management for Falls Prevention on Functional Outcomes in Community-Dwelling Older People: A Randomized Clinical Study.

To evaluate the effects of a multifactorial fall prevention program based on CM on physical performance, the presence of pain, and the risk of falls and fractures in older people who have suffered falls. This randomized, single-blind clinical trial with parallel groups, Intervention Group (IG) and Control Group (CG), was composed of 55 older people with a history of falling, living in the community. All participants underwent an initial assessment via video call (containing anamnesis, timed up-and-go test, falls risk score, short physical performance battery, and clinical frax). The IG underwent CM, the physical exercise protocol, and the cognitive stimulation protocol. The CG was monitored through telephone calls and received general health and fall guidance. No significant results were found in the physical capacity, the presence of pain, the risk of falls, or the fractures between the Intervention and Control Groups and between assessments. This program was not effective in improving functional performance, but it was important for characterizing pain and the probability of fracture in the next 10 years in this population.

Efficacy of the combination of water aerobics and metacognitive training on psychological and physical health variables and their relationship with SP1 and SP4 biomarkers in people with psychosis: a study protocol.

Metacognitive Training (MCT) is widely used and effective in reducing positive symptoms in psychosis. Physical exercise, such as Water Aerobics (WA), improves general health, quality of life and symptoms as a low impact activity that allows social interactions. Preliminary results suggest a relationship between dopamine and psychotic symptoms, through SP transcription factors, SP1 and SP4 biomarkers. The aims of the project are to evaluate the efficacy of a combined intervention (WA and MCT) for psychosis to improve psychotic symptoms, physical health, and transcription levels of SP biomarkers. This is a unicentric randomized controlled trial of three parallel intervention groups: MCT, WA and combined intervention. The estimated sample will be 48 patients with a psychotic spectrum disorder diagnosis. The assessment will be performed at baseline and at 2-months' follow-up. Instruments used in the assessment will include clinical, cognitive, metacognitive, social cognitive and psychosocial variables. This will be the first study investigating the impact of the combination of MCT and WA in psychosis. Moreover, it will be the first study analyzing changes in the transcriptional biomarkers SP1 and SP4 after interventions. The results of this study may have clinical implications contributing to the improvement of treatment selection. https://clinicaltrials.gov/, identifier: NCT05455593.

A single-blinded, randomized, parallel intervention to evaluate genetics and omics-based personalized nutrition in general population via an e-commerce tool: The PREVENTOMICS e-commerce study

BackgroundPersonalized nutrition (PN) has been proposed as a strategy to increase the effectiveness of dietary recommendations and ultimately improve health status. ObjectivesWe aimed to assess whether including omics-based PN in an e-commerce tool improves dietary behavior and metabolic profile in general population. MethodsA 21-wk parallel, single-blinded, randomized intervention involved 193 adults assigned to a control group following Mediterranean diet recommendations (n = 57, completers = 36), PN (n = 70, completers = 45), or personalized plan (PP, n = 68, completers = 53) integrating a behavioral change program with PN recommendations. The intervention used metabolomics, proteomics, and genetic data to assist participants in creating personalized shopping lists in a simulated e-commerce retailer portal. The primary outcome was the Mediterranean diet adherence screener (MEDAS) score; secondary outcomes included biometric and metabolic markers and dietary habits. ResultsVolunteers were categorized with a scoring system based on biomarkers of lipid, carbohydrate metabolism, inflammation, oxidative stress, and microbiota, and dietary recommendations delivered accordingly in the PN and PP groups. The intervention significantly increased MEDAS scores in all volunteers (control—3 points; 95% confidence interval [CI]: 2.2, 3.8; PN—2.7 points; 95% CI: 2.0, 3.3; and PP—2.8 points; 95% CI: 2.1, 3.4; q < 0.001). No significant differences were observed in dietary habits or health parameters between PN and control groups after adjustment for multiple comparisons. Nevertheless, personalized recommendations significantly (false discovery rate < 0.05) and selectively enhanced the scores calculated with biomarkers of carbohydrate metabolism (β: −0.37; 95% CI: −0.56, −0.18), oxidative stress (β: −0.37; 95% CI: −0.60, −0.15), microbiota (β: −0.38; 95% CI: −0.63, −0.15), and inflammation (β: −0.78; 95% CI: −1.24, −0.31) compared with control diet. ConclusionsIntegration of personalized strategies within an e-commerce–like tool did not enhance adherence to Mediterranean diet or improved health markers compared with general recommendations. The metabotyping approach showed promising results and more research is guaranteed to further promote its application in PN.This trial was registered at clinicaltrials.gov as NCT04641559 (https://clinicaltrials.gov/study/NCT04641559?cond=NCT04641559&rank=1).

Mindfulness-based Stress Reduction and Endothelial Function in Chronic Kidney Disease

Introduction: Chronic Kidney Disease (CKD) is associated with increased cardiovascular disease risk in part due to endothelial dysfunction. Studies have suggested that mindfulness-based stress reduction (MBSR) may have beneficial physiologic effects on cardiovascular disease risk; however, the potential beneficial effects of MBSR on endothelial function in CKD are unknown. We tested the hypothesis that MBSR improves endothelial function in patients with CKD. Methods: Participants with CKD (Stages III-IV) were enrolled and randomized to 8 weeks of MBSR versus the Health Enhancement Program (HEP), a structurally parallel control intervention to MBSR. Each intervention consisted of daily homework and 2.5hr weekly classes of mindfulness meditation (for MBSR) and health education (for HEP). Each intervention also included a day-long retreat. Endothelial function was quantified as brachial artery reactive hyperemia index (RHI) using peripheral artery tonometry (EndoPAT). RHI and offce blood pressure were obtained at baseline and at the end of the intervention. Intervention groups were also stratified into subgroups based on normal (RHI ≥2.10) and abnormal (RHI &lt;2.10) baseline values for secondary analyses. Results: Data were obtained from 37 participants with CKD who were enrolled and randomized to MBSR (N=21) versus HEP (N=16). There were no differences in baseline characteristics, hemodynamics or RHI between groups. There were no significant differences in baseline versus end of study RHI within (HEP p=0.76; MBSR p=0.57) and between intervention groups (p=0.36). There was no difference in change in RHI after MBSR between the normal and abnormal RHI subgroups. Conclusions: MBSR did not have significant effects on endothelial function measured as RHI among individuals with CKD. Supported by NIH Grants R33AT010457 and R01HL135183. This is the full abstract presented at the American Physiology Summit 2024 meeting and is only available in HTML format. There are no additional versions or additional content available for this abstract. Physiology was not involved in the peer review process.

Prophylactic negative pressure wound therapy to improve wound healing rates following ileostomy closure: a randomized controlled trial.

Reversal of ileostomy is associated with morbidity including wound infection and prolonged wound healing. Negative pressure wound therapy (NPWT) has been shown to reduce time to wound healing by secondary intention. The aim of this study was to determine whether NPWT improved wound healing rates, compared with simple wound dressings, in patients undergoing reversal of ileostomy where the skin wound is closed with a purse-string suture. This was a dual-centre, open-label, randomized controlled trial with two parallel intervention arms. Patients undergoing elective loop ileostomy reversal were randomized 1:1 to receive NPWT or simple wound dressings. The primary endpoint of the study was assessment of complete wound healing at day 42 post reversal of ileostomy and the secondary endpoints were patient-reported wound cosmesis using a visual analogue scale and rates of surgical site infection (SSI). The study was conducted from June 2018 to December 2021. The trial was approved by the local ethics committee. We enrolled 40 patients, 20 in each arm. One patient in each arm was lost to follow up. Nine patients (9/19, 47.36%) in the simple dressing group had wound healing vs. 13 patients (13/19, 68.42%) in the NPWT group (P = 0.188). There was no significant difference in patient- reported wound cosmesis or SSI. There was no difference in wound healing rates when comparing NPWT to simple wound dressings at early and late time points post reversal of ileostomy, where the skin wound was closed with a purse-string suture.

Assessment of therapeutic clinical trials for proximal humeral fractures.

Proximal humeral fractures (PHFs) are a common injury among the older population. An ideal therapeutic protocol has yet to be developed, and numerous clinical trials are being conducted to find the best therapeutic approach. The purpose of this study is to evaluate the current body of knowledge available via interventional clinical trials. In December 2022, interventional clinical trials relating to PHFs on Clinicaltrials.gov were screened. Trial characteristics included duration, status, intervention, phase, outcomes, location, and study design. Publications associated with each trial were searched on PubMed/Medline using the ClinicalTrials.gov registry number. The final dataset comprised 64 trials. The most common trial status was completed (36%). The majority did not have a Food and Drug Administration-defined phase (67%), was randomized (81%), involved a single facility (72%), used a parallel assignment intervention model (80%), and used an open-label approach (45%). Eleven trials were associated with a publication, and the publication rate was 17%. Average enrollment was 86 participants, and mean trial duration was 51.4 months. Europe/UK/Russia/Turkey participated in the most trials (70%). Most of the trials were initiated after 2010 (87.5%). Procedure-related interventions (55%) were most common. Disability/function was the most common primary outcome assessed (61%). The low publication rate and the multitude of trials conducted after 2010 highlight the urgency and need for trial results to be published to establish an ideal therapeutic protocol. Since the majority of the trials involved a single institution and an open-label approach, reinforcing blinding and establishing multi-centered trials can improve the validity of the clinical trial results.

Interindividual differences in aronia juice tolerability linked to gut microbiome and metabolome changes—secondary analysis of a randomized placebo-controlled parallel intervention trial

BackgroundAronia melanocarpa is a berry rich in polyphenols known for health benefits. However, the bioavailability of polyphenols has been questioned, and the individual taste acceptance of the fruit with its specific flavor varies. We recently observed substantial differences in the tolerability of aronia juice among healthy females, with half of the individuals tolerating aronia juice without complaints. Given the importance of the gut microbiome in food digestion, we investigated in this secondary analysis of the randomized placebo-controlled parallel intervention study (ClinicalTrials.gov registration: NCT05432362) if aronia juice tolerability was associated with changes in intestinal microbiota and bacterial metabolites, seeking for potential mechanistic insights into the impact on aronia polyphenol tolerance and metabolic outcomes.ResultsForty females were enrolled for this 6-week trial, receiving either 100 ml natural aronia juice (verum, V) twice daily or a polyphenol-free placebo (P) with a similar nutritional profile, followed by a 6-week washout. Within V, individuals were categorized into those who tolerated the juice well (Vt) or reported complaints (Vc). The gut microbiome diversity, as analyzed by 16S rRNA gene-based next-generation sequencing, remained unaltered in Vc but changed significantly in Vt. A MICOM-based flux balance analysis revealed pronounced differences in the 40 most predictive metabolites post-intervention. In Vc carbon-dioxide, ammonium and nine O-glycans were predicted due to a shift in microbial composition, while in Vt six bile acids were the most likely microbiota-derived metabolites. NMR metabolomics of plasma confirmed increased lipoprotein subclasses (LDL, VLDL) post-intervention, reverting after wash out. Stool samples maintained a stable metabolic profile.ConclusionIn linking aronia polyphenol tolerance to gut microbiota-derived metabolites, our study explores adaptive processes affecting lipoprotein profiles during high polyphenol ingestion in Vt and examines effects on mucosal gut health in response to intolerance to high polyphenol intake in Vc. Our results underpin the importance of individualized hormetic dosing for beneficial polyphenol effects, demonstrate dynamic gut microbiome responses to aronia juice, and emphasize personalized responses in polyphenol interventions.Graphical DsmAL-oYwbuhyB_vVwEdDjVideo

Forests serve vulnerable groups in times of crises: improved mental health of older adults by individual forest walking during the COVID-19 pandemic

Understanding the effects of environment on the mental health of older adults is crucial in an aging society. Previous research concerning restorative benefits of forests almost entirely omitted older adults as the primary target group and typically involved group forest visits, which were largely restricted during the COVID-19 pandemic. Here we investigated the effects of individual walks on the mental health of adults aged 60 years or older (N = 54). A randomized parallel intervention study was conducted with one group walking in forests and the other in built-up city centres. Each participant completed eight individual 40-min walks during 1 month. Significant improvements in cognitive flexibility and heart rate variability (HRV) as an autonomic nervous system functioning indicator were established in the forest-walking group. The relationship between HRV and environment was modulated by ambient temperature. The study shows that access to forests during crises can support mental health of older adults as a vulnerable demographic.

Multimodal home-based rehabilitation intervention after discharge from inpatient geriatric rehabilitation (GeRas): study protocol for a multicenter randomized controlled trial

BackgroundGeriatric rehabilitation aims to maintain the functional reserves of older adults in order to optimize social participation and prevent disability. After discharge from inpatient geriatric rehabilitation, patients are at high risk for decreased physical capacity, increased vulnerability, and limitations in mobility. As a result, ageing in place becomes uncertain for a plethora of patients after discharge from geriatric rehabilitation and effective strategies to prevent physical decline are required. Collaboration between different health-care providers is essential to improve continuity of care after discharge from inpatient geriatric rehabilitation. The aim of this study is to evaluate the effectiveness of a multi-professional home-based intervention program (GeRas) to improve functional capacity and social participation in older persons after discharge from inpatient geriatric rehabilitation.MethodsThe study is a multicenter, three-arm, randomized controlled trial with a three-month intervention period. Two hundred and seventy community-dwelling older people receiving inpatient geriatric rehabilitation will be randomized with a 1:1:1 ratio to one of the parallel intervention groups (conventional IG or tablet IG) or the control group (CG). The participants of both IGs will receive a home-based physical exercise program supervised by physical therapists, a nutritional recommendation by a physician, and social counseling by social workers of the health insurance company. The collaboration between the health-care providers and management of participants will be realized within a cloud environment based on a telemedicine platform and supported by multi-professional case conferences. The CG will receive usual care, two short handouts on general health-related topics, and facultative lifestyle counseling with general recommendations for a healthy diet and active ageing. The primary outcomes will be the physical capacity measured by the Short Physical Performance Battery and social participation assessed by the modified Reintegration to Normal Living Index, three months after discharge.DiscussionThe GeRas program is designed to improve the collaboration between health-care providers in the transition from inpatient geriatric rehabilitation to outpatient settings. Compared to usual care, it is expected to improve physical capacity and participation in geriatric patients after discharge from inpatient geriatric rehabilitation.Trial registrationGerman Clinical Trials Register (DRKS00029559). Registered on October 05, 2022.

An examination of the impact of unmelted, melted, and deconstructed cheese on lipid metabolism: a 6-week randomised trial.

Background: Evidence suggests cheese has a favourable or neutral effect on cardiometabolic health, compared to butter. To date, studies have only considered the cheese matrix in its unmelted form, while the effect of melted cheese remains unknown. Objective: To test the effect of 6-week daily consumption of ∼40 g dairy fat, eaten in either as unmelted cheese, melted cheese, or in a fully deconstructed form, on markers of metabolic health in overweight adults aged ≥50 years of age. Design: A 6-week randomised parallel intervention, where 162 participants (43.3% male) received ∼40 g of dairy fat per day, in 1 of 3 treatments: (A) 120 g full-fat Irish grass-fed cheddar cheese, eaten in unmelted form (n 58); (B) 120 g full-fat Irish grass-fed cheddar cheese eaten in melted form (n 53); or (C) the equivalent components; butter (49 g), calcium caseinate powder (30 g), and Ca supplement (CaCO3; 500 mg) (n 51). Results: There was no difference in weight, fasting glucose, or insulin between the groups post-intervention. Melted cheese, compared to unmelted cheese, increased total cholesterol (0.23 ± 0.79 mmol L-1vs. 0.02 ± 0.67 mmol L-1, P = 0.008) and triglyceride concentrations (0.17 ± 0.39 mmol L-1vs. 0.00 ± 0.42 mmol L-1, P = 0.016). Melted cheese increased total cholesterol concentrations by 0.20 ± 0.15 mmol L-1 and triglyceride concentrations by 0.17 ± 0.08 mmol L-1 compared to unmelted cheese. No significant differences were observed between the cheese forms for change in HDL, LDL or VLDL cholesterol. Conclusion: Compared to unmelted cheese, melted cheese was found to increase total cholesterol and triglyceride concentrations in middle-aged, overweight adults with no effect on weight or glycaemic control.