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Effectiveness of protein supplementation combined with resistance training to counteract disproportional fat-free mass loss following metabolic bariatric surgery: rationale and design of the ENRICHED randomised controlled trial

Por: de Roos · B. M. · Yeh · L.-L. Y. · van den Hooff · P. S. · Nuijten · M. A. H. · Twisk · J. W. R. · Liem · R. S. L. · van Acker · G. J. D. · Severens · J. L. · Kambic · T. · Serlie · M. J. M. · Monpellier · V. M. · Eijsvogels · T. M. H. · Hopman · M. T. E. · Karregat · J. H. M.
Introduction

Metabolic bariatric surgery (MBS) can lead to substantial fat-free mass loss (FFML) due to malnutrition, decreased protein intake and insufficient physical activity. Disproportional FFML has been associated with an increased risk for adverse health outcomes. Resistance training (RT) combined with protein intake contributes to maintenance and increase of fat-free mass (FFM) in healthy individuals. However, it is unclear whether RT and protein supplementation can prevent FFML after MBS.

Methods and analysis

In the EffectiveNess of pRotein supplementatIon Combined witH resistance Exercise training to counteract Disproportional fat-free mass loss following metabolic bariatric surgery (ENRICHED) randomised controlled trial, 400 patients scheduled to undergo MBS will be randomised in a 1:1 ratio to the ENRICHED perioperative care programme (intervention group) or the standard perioperative care programme of the Dutch Obesity Clinic (control group). The study is currently recruiting participants at two centres in the Netherlands: Nieuwegein and Amsterdam. The postoperative standard programme consists of 13 group sessions spread over a period of 18 months. As part of the ENRICHED programme, RT and protein supplementation will be added 3 weeks after MBS. Additional whole-body RT consists of home-based training sessions two to three times a week, and supervised RT sessions of 45–60 min once weekly, performed at 60–75% of one-repetition maximum (1-RM). Protein supplementation will start by adding 20 g of whey protein to the daily intake. The supplementation will be gradually increased with 20 g every 4 weeks until a total of 60 g whey protein a day is reached. After 12 weeks of protein supplementation, the focus shifts towards incorporating protein-rich food products into the daily dietary intake. The primary endpoint is the prevalence of disproportional FFM loss, defined as FFML/total weight loss ≥30%, at 3 months post-MBS. Secondary endpoints are differences in body composition, muscle strength and function, cardiorespiratory fitness, (cardio)metabolic health, health-related quality of life, gastrointestinal discomfort, cost-effectiveness of the intervention and treatment satisfaction. Outcomes will be assessed preoperatively and at 3, 6 and 12 months postoperatively.

Ethics and dissemination

The study protocol V.2.0 was approved by the Medical Research Ethics Committee Oost-Nederland (NL-OMON57119) on 9 April 2025. All participants will provide written informed consent prior to enrolment. Study findings will be disseminated through peer-reviewed publications and conference presentations. Insights gained in this study will provide evidence for a patient-tailored intervention that could be implemented in clinical practice.

Trial registration number

NCT07156552.

Study Protocol of a feasibility and acceptability trial of Problem Management Plus with Emotional Processing (PM+EP) for forcibly displaced youth living in Sweden

Por: Mattelin · E. · Alozkan-Sever · C. · Shahnavaz · S. · Sijbrandij · M. · Mittendorfer-Rutz · E. · Akhtar · A.
Introduction

Heightened rates of mental illness among children, young people and forcibly displaced adults are well-documented. Despite this, access to care in host countries is often low. Problem-management plus (PM+) is an intervention developed by the WHO that can be delivered through task-shifting by lay counsellors and has been shown to be effective in numerous studies. At the same time, it has been shown that PM+ has a limited effect on traumatic stress symptoms, a common problem among forcibly displaced individuals. In turn, to further these benefits, a novel emotional processing (EP) module has been developed to be adjunctively delivered alongside PM+(PM+EP).

Method and analysis

The current study is a randomised controlled feasibility and acceptability study. 60 participants aged 16–25 will be randomly allocated to either PM+, PM+EP or care as usual. The primary outcome of this study will be the feasibility and acceptability of the delivery of PM+EP in forcibly displaced youth. Secondary outcomes are self-rated measures of distress, depression and anxiety, post-traumatic stress disorder, personally identified problems, hope, use of services and medications, general well-being and social support.

Ethics and dissemination

Following ethical approval in February 2024, recruitment commenced in October 2024. Study completion is anticipated by December 2025. Findings will be disseminated via peer-reviewed publications, conference presentations and communication with relevant stakeholders.

Trial registration number

NCT06878092.

Virtual reality-based home accident control simulation combined with first aid training to enhance awareness in parents of children with special needs: protocol for a single-group pre-post quasi-experimental study

Por: Ertunc Gulcelik · G. · Ortabag · T. · Yilmaz · S. · Sever · E. · Eryigit · T.
Introduction

Children with special needs frequently experience accidents and injuries due to motor control difficulties. The most common home accidents include falls, burns, poisoning, drowning and choking. Compared to their typically developing peers, children with special needs are at a higher risk of home accidents and emergency department visits. Falls related to balance impairments are especially common in this population. The aim of this study is to assess the effects of a virtual reality-based home accident control simulation combined with first aid training on the awareness and initial responses to home accidents of parents of children with special needs, using a single-group pre-post quasi-experimental design.

Methods and analysis

This quasi-experimental study, using a pre-test/post-test design, is planned to include 100 volunteer parents of children with special needs who are registered at a Barrier-Free Life Application and Research Centre. The parents will receive training on home accidents via virtual reality simulation, supplemented by first aid and transfer training. Data will be collected using the Descriptive Information Form and the Home Accident Awareness Questionnaire for Parents of Children with Special Needs. Children’s balance status will be assessed to determine their fall risk using the Children’s Balance Assessment Form, the Tinetti Balance and Gait Assessment and the Nintendo Wii Fit Balance Board.

Ethics and dissemination

Ethical approval was obtained from the Ethics Committee of Istanbul Topkapi University. The results will be disseminated through peer-reviewed journals and academic conferences.

Trial registration number

NCT06839196 (ClinicalTrials.gov). Protocol version: 1.2; Protocol Date: 30 April 2025. All items from the WHO Trial Registration Data Set are available in the registry record.

Pooled, Frozen, Gamma‐Irradiated Amniotic Fluid Enhances Histomorphological Remodelling in Hypertrophic Scars

ABSTRACT

Hypertrophic scars (HTSs) result from excessive collagen accumulation and impaired wound remodelling, leading to considerable aesthetic and functional concerns. Despite the availability of various treatment strategies, their clinical success remains limited, emphasising the need for alternative approaches. Human amniotic fluid (hAF), naturally enriched with cytokines and growth factors, has emerged as a promising biological material for tissue regeneration. This study investigated the therapeutic potential of two forms of hAF—pooled-frozen and pooled-frozen gamma-irradiated—in a rat model of hypertrophic scarring. Fifteen adult male Sprague–Dawley rats were randomly assigned to receive subcutaneous injections of either saline, pooled-frozen hAF, or pooled-frozen gamma-irradiated hAF at the wound margins on days 1, 3 and 5 following the induction of hypertrophic scars via talc powder application. After 21 days, wound healing was evaluated through histological and immunohistochemical analyses. Both treatment groups demonstrated significantly improved wound healing compared to the control group. Granulation tissue formation was enhanced in the treated groups, particularly in animals receiving gamma-irradiated fluid, which also showed superior collagen remodelling characterised by aligned and mature collagen bundles. Both treatment groups demonstrated an increase in M2 macrophage density, as evidenced by elevated Arg+/CD68+ cell ratios; however, this effect was more pronounced in the gamma-irradiated group, indicating a stronger shift towards a regenerative immune profile. Enhanced reepithelialisation, increased hair follicle density and reduced scar thickness were also observed. These findings suggest that gamma-irradiated hAF provides a more effective and minimally invasive therapeutic option for modulating scar formation and improving wound healing outcomes, supporting its potential translation into clinical applications for the management of hypertrophic scars.

Effect of strategies to improve interhospital transports of critically ill patients on safety and costs: protocol for a systematic review and meta-analysis

Por: Severino · F. · Gallani · M.-C. · Mercier · E. · Ouellet · S. · Tremblay-Roy · J.-S. · Lapierre · A. · Malo · C. · Boivin · A. · Berube · M.
Introduction

Transporting critically ill patients between medical facilities can be hazardous and costly. Whether by road, fixed-wing aircraft or helicopter, many professional associations have proposed strategies to efficiently and safely transport patients at high risk of instability. Although these strategies have been assessed in some studies, no comprehensive synthesis of their benefits has been conducted to date. The aim of this study is to assess the effect of strategies to improve the safety and costs of interhospital transports for critically ill patients.

Methods and analysis

We will conduct a systematic review according to the Cochrane guidelines. The review will include randomised controlled trials (RCTs), cohort studies and case-control studies assessing the effect of interventions to improve interhospital transports of critically ill patients on safety and costs. We will search multiple electronic databases (PubMed, EMBASE, CINAHL, Web of Science, Cochrane Library) from inception to 6 months prior to the submission of the final manuscript. Screening by title and abstract, full-text screening, data extraction and quality assessment will be performed by two independent reviewers. We will assess the risk of bias with the Cochrane revised tool for RCTs and with the risk of bias in non-randomised studies of interventions tool. If possible, we will calculate pooled effect estimates and 95% CIs to assess the effect of the interventions. We will also assess heterogeneity using the I2 index and rate the certainty of evidence with the Grading of Recommendations Assessment, Development and Evaluation tool and trial sequential analysis.

Ethics and dissemination

Ethics approval is not required for this review. The results of this systematic review will be shared through publication in a peer-reviewed journal, conference presentations and our network of knowledge user collaborators.

PROSPERO registration number

International Prospective Register of Systematic Reviews (CRD42024595080).

Nursing practices on sexual health for people with neurological disorders: A narrative review

Abstract

Aims

To identify and describe nursing practices on the sexual health of people with neurological disorders.

Design

Narrative review.

Methods

Data were extracted from 1 January 2002, to 20 May 2021. Inclusion criteria were nursing practices, sexual health and people with neurological disorders. The main outcome measures were: context of nursing practice implementation (assumptions, knowledge, strategies and skills), facilitators of and barriers to addressing and treating the sexual health of people with neurological disorders, and benefits of nursing practices in sexual health. PRISMA reporting guidelines were used.

Data Sources

PubMed, Embase, ScienceDirect and CINAHL.

Results

In total, 926 articles were identified and nine were included. The involvement of nurses was recommended in most studies. Assumptions about the impact of neurology on sexuality and nurse's role in sexual healthcare, biopsychosocial knowledge, and skills (ethical, interpersonal, and technical) were highlighted. We found that the modes of knowledge proposed by Carper were mobilized in an unequal way. Sexual difficulties were the key focus and eroticization concerns were not addressed in any of the articles.

Conclusion

Several studies advocate nursing intervention; however, few accurately present, detail and evaluate sexual health nursing practices of patients with neurological pathologies. Literature describes practices structured around disorders rather than the potentials, fails to address the brake of eroticism and provides little information on the results of interventions.

Implications for the Profession and/or Patient Care

Developing teaching programs on sexual health in nursing programs may be necessary if nurses are to support a diverse range of patients in an inclusive and positive manner. These programs should highlight the domain-specific knowledge that is mobilized.

Impact

Sexual health is a fundamental human right. Alterations in the nervous system have shown to affect sexual health, however, it is not often discussed among patients with neurological disorders, who are rarely provided with sexual health counselling. Our findings may impact healthcare professionals engaged in care with these patients.

Reporting Method

PRISMA.

No patient or public contribution.

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