Frail2Fit study protocol: a feasibility and acceptability study of a virtual multimodal intervention delivered by volunteers to improve functional outcomes in older adults with frailty after discharge from hospital.

INTRODUCTION: Physical activity (PA) and replete nutritional status are key to maintaining independence and improving frailty status among frail older adults. In response to the COVID-19 pandemic, healthcare has increasingly turned to virtual modes of delivery and there is interest in the use of trained volunteers to deliver PA and nutrition interventions. We aim to evaluate the feasibility and acceptability of training hospital volunteers to deliver an online intervention, comprising exercise, behaviour change and nutrition support, to older people with frailty after discharge from hospital. METHODS: We will use a quasi-experimental mixed methods approach. Hospital volunteers (n=6) will be trained to deliver an online, 3-month, multimodal intervention to frail (Clinical Frailty Scale ≥5) adults ≥65 years (n=30) after discharge from hospital. Feasibility will be assessed by determining the number of volunteers recruited, trained and retained at the end of the study; the proportion of intervention sessions delivered; participant recruitment, retention and adherence to the intervention. To determine the acceptability of the intervention, interviews will be conducted among a purposive sample of older adults, and volunteers. Secondary outcomes will include physical function, appetite, well-being, quality of life, anxiety and depression, self-efficacy for managing chronic disease and PA. Outcomes will be measured at baseline, 3 months and 6 months. ANALYSIS: Descriptive statistics will be used to describe feasibility and adherence to the intervention. Secondary outcomes at baseline will be compared at 3 and 6 months. Interviews will be transcribed verbatim and analysed using thematic analysis. ETHICS AND DISSEMINATION: Health Research Authority ethical approval was obtained on 30 May 2022 (reference: 22/WA/0155). Results will be disseminated through peer-reviewed journal articles, volunteer organisations, National Health Service communication systems and social media platforms. A toolkit will be developed to facilitate roll out of volunteer training. TRIAL REGISTRATION NUMBER: NCT05384730

Engaging adolescents in changing behaviour (EACH-B): A study protocol for a cluster randomised controlled trial to improve dietary quality and physical activity

Background Poor diet and lack of physical activity are strongly linked to non-communicable disease risk, but modifying them is challenging. There is increasing recognition that adolescence is an important time to intervene; habits formed during this period tend to last, and physical and psychological changes during adolescence make it an important time to help individuals form healthier habits. Improving adolescents’ health behaviours is important not only for their own health now and in adulthood, but also for the health of any future children. Building on LifeLab—an existing, purpose-built educational facility at the University of Southampton—we have developed a multi-component intervention for secondary school students called Engaging Adolescents in Changing Behaviour (EACH-B) that aims to motivate and support adolescents to eat better and be more physically active. Methods A cluster randomised controlled trial is being conducted to evaluate the effectiveness of the EACH-B intervention. The primary outcomes of the intervention are self-reported dietary quality and objectively measured physical activity (PA) levels, both assessed at baseline and at 12-month follow-up. The EACH-B intervention consists of three linked elements: professional development for teachers including training in communication skills to support health behaviour change; the LifeLab educational module comprising in-school teaching of nine science lessons linked to the English National Curriculum and a practical day visit to the LifeLab facility; and a personalised digital intervention that involves social support and game features that promote eating better and being more active. Both the taught module and the LifeLab day are designed with a focus on the science behind the messages about positive health behaviours, such as diet and PA, for the adolescents now, in adulthood and their future offspring, with the aim of promoting personal plans for change. The EACH-B research trial aims to recruit approximately 2300 secondary school students aged 12–13 years from 50 schools (the clusters) from Hampshire and neighbouring counties. Participating schools will be randomised to either the control or intervention arm. The intervention will be run during two academic years, with continual recruitment of schools throughout the school year until the sample size is reached. The schools allocated to the control arm will receive normal schooling but will be offered the intervention after data collection for the trial is complete. An economic model will be developed to assess the cost-effectiveness of the EACH-B intervention compared with usual schooling. Discussion Adolescents’ health needs are often ignored and they can be difficult to engage in behaviour change. Building a cheap, sustainable way of engaging them in making healthier choices will benefit their long-term health and that of their future children. Trial registration ISRCTN 74109264. Registered on 30 August 2019. EACH-B is a cluster randomised controlled trial, funded by the National Institute for Health Research (RP-PG-0216-20004)

SafeFit Trial: Virtual clinics to deliver a multimodal intervention to improve psychological and physical wellbeing in people with cancer. Protocol of a COVID-19 targeted non-randomised phase III trial

Introduction: The impact of the COVID-19 pandemic (caused by the SArS-CoV-2 virus), on individuals with cancer has been profound. It has led to increased anxiety, distress and deconditioning due to reduced physical activity. We aim to investigate whether SafeFit; a multi-modal intervention of physical activity, nutrition and psychological support delivered virtually by cancer exercise specialists (CES) can improve physical and emotional functioning during the COVID-19 pandemic.Methods and analysis: A phase III non-randomised intervention trial, target recruitment of 1050 adults with suspected or confirmed diagnosis of cancer. All recruited participants will receive the multimodal intervention delivered by CES for six months. Sessions will be delivered 1-to-1 using telephone/video conferencing consultations. CES will work with each participant to devise a personalised programme of 1) physical activity, 2) basic dietary advice and 3) psychological support, all underpinned by a behaviour change intervention.Primary outcome: Physical and emotional functioning as measured by the EORTC-QLQ-C30. Secondary outcomes: Overall quality of life measured by EORTC-QLQ-C30 and EQ-5D-5L, health economics, patient activation, self-efficacy to self-manage chronic disease, distress, Impact of Covid-19 on emotional functioning, self-reported physical activity, functional capacity and nutrition. Adherence to the intervention will also be measured and a process evaluation conducted. Ethics and dissemination: Ethical approval was obtained from the Health Research Authority (reference number: 20/NW/0254). Results of this trial will be disseminated through publication of peer reviewed articles, presentations at scientific conferences and to the public and people with cancer in collaboration with our patient and public involvement representatives and partners. Trial registration: NCT0442561

The effects of neoadjuvant chemoradiotherapy and an in-hospital exercise training programme on physical fitness and quality of life in locally advanced rectal cancer patients: a randomised controlled trial (The EMPOWER Trial)

Background The EMPOWER trial aimed to assess the effects of a 9-week exercise prehabilitation programme on physical fitness compared with a usual care control group. Secondary aims were to investigate the effect of (1) the exercise prehabilitation programme on psychological health; and (2) neoadjuvant chemoradiotherapy (NCRT) on physical fitness and psychological health. Methods Between October 2013 and December 2016, adults with locally advanced rectal cancer undergoing standardised NCRT and surgery were recruited to a multi-centre trial. Patients underwent cardiopulmonary exercise testing (CPET) and completed HRQoL questionnaires (EORTC-QLQ-C30 and EQ-5D-5L) pre-NCRT and post-NCRT (week 0/baseline). At week 0, patients were randomised to exercise prehabilitation or usual care (no intervention). CPET and HRQoL questionnaires were assessed at week 0, 3, 6 and 9, whilst semi-structured interviews were assessed at week 0 and week 9. Changes in oxygen uptake at anaerobic threshold (VO2 at AT (ml kg−1 min−1)) between groups were compared using linear mixed modelling. Results Thirty-eight patients were recruited, mean age 64 (10.4) years. Of the 38 patients, 33 were randomised: 16 to usual care and 17 to exercise prehabilitation (26 males and 7 females). Exercise prehabilitation significantly improved VO2 at AT at week 9 compared to the usual care. The change from baseline to week 9, when adjusted for baseline, between the randomised groups was + 2.9 ml kg −1 min −1; (95% CI 0.8 to 5.1), p = 0.011. Conclusion A 9-week exercise prehabilitation programme significantly improved fitness following NCRT. These findings have informed the WesFit trial (NCT03509428) which is investigating the effects of community-based multimodal prehabilitation before cancer surgery. Trial registration ClinicalTrials.gov NCT01914068. Registered 1 August 2013

The Role of Behavioral Science in Personalized Multimodal Prehabilitation in Cancer

Multimodal prehabilitation is increasingly recognized as an important component of the pre-operative pathway in oncology. It aims to optimize physical and psychological health through delivery of a series of tailored interventions including exercise, nutrition, and psychological support. At the core of this prescription is a need for considerable health behavior change, to ensure that patients are engaged with and adhere to these interventions and experience the associated benefits. To date the prehabilitation literature has focused on testing the efficacy of devised exercise and nutritional interventions with a primary focus on physiological and mechanistic outcomes with little consideration for the role of behavioral science, supporting individual behavior change or optimizing patient engagement. Changing health behavior is complex and to maximize success, prehabilitation programs should draw on latest insights from the field of behavioral science. Behavioral science offers extensive knowledge on theories and models of health behavior change to further advance intervention effectiveness. Similarly, interventions developed with a person-centered approach, taking into consideration individual needs and preferences will increase engagement. In this article, we will provide an overview of the extent to which the existing prehabilitation literature incorporates behavioral science, as well as studies that have explored patient's attitudes toward prehabilitation. We will go on to describe and critique ongoing trials in a variety of contexts within oncology prehabilitation and discuss how current scientific knowledge may be enhanced from a behavioral science perspective. We will also consider the role of "surgery schools" and detail practical recommendations that can be embedded in existing or emerging clinical settings

Multimorbidity in Difficult Asthma: The Need for Personalised and Non-Pharmacological Approaches to Address a Difficult Breathing Syndrome

Three to ten percent of people living with asthma have difficult-to-treat asthma that remains poorly controlled despite maximum levels of guideline-based pharmacotherapy. This may result from a combination of multiple adverse health issues including aggravating comorbidities, inadequate treatment, suboptimal inhaler technique and/or poor adherence that may individually or collectively contribute to poor asthma control. Many of these are potentially “treatable traits” that can be pulmonary, extrapulmonary, behavioural or environmental factors. Whilst evidence-based guidelines lead clinicians in pharmacological treatment of pulmonary and many extrapulmonary traits, multiple comorbidities increase the burden of polypharmacy for the patient with asthma. Many of the treatable traits can be addressed with non-pharmacological approaches. In the current healthcare model, these are delivered by separate and often disjointed specialist services. This leaves the patients feeling lost in a fragmented healthcare system where clinical outcomes remain suboptimal even with the best current practice applied in each discipline. Our review aims to address this challenge calling for a paradigm change to conceptualise difficult-to-treat asthma as a multimorbid condition of a “Difficult Breathing Syndrome” that consequently needs a holistic personalised care attitude by combining pharmacotherapy with the non-pharmacological approaches. Therefore, we propose a roadmap for an evidence-based multi-disciplinary stepped care model to deliver this

Does the nature of adult difficult asthma differ by age of onset? Findings from WATCH

Background: Phenotypic differences between early-onset (EODA) and adult-onset (AODA) difficult asthma in adulthood are not well described. Aim: To characterise EODA and AODA in difficult asthma. Methods: The Wessex AsThma CoHort of difficult asthma (WATCH) is a longitudinal study at University Hospital Southampton (UHS) UK set up in 2015. To date, 380 patients are enrolled from the UHS tertiary difficult asthma clinic. Clinical features of EODA (age ≤18 yrs) and AODA (age >18 yrs) are presented here. Results: Of 368 patients with available data, 51.6% had EODA and 48.4% AODA (median age of onset 4.0 yrs v 40.5 yrs respectively (

Sex differences in difficult asthma; findings in the WATCH cohort

Background: Difficult asthma is comprised of many phenotypes, but how sex influences such patterns of disease remains unclear. Aims: To assess how the nature of difficult asthma seen in clinical practice differs between males and females. Methods: We studied patients enrolled (n=380) from a tertiary difficult asthma clinic (Southampton, UK) into a longitudinal Wessex AsThma CoHort (WATCH) assessing comparisons of core features stratified by sex. Results: Two thirds of subjects were female. Male participants were significantly older (median age 59.5 years v 48; p<0.001), and were also older at diagnosis, (median age of 31.0 years v 15; p<0.001). Males were less likely to have a smoking history (p=0.003), more likely to have a history of non-CF bronchiectasis (p=0.003), and demonstrated a higher peripheral eosinophil count (p=0.018). Females were more likely to be salicylate sensitive (33.5% v 13.3%, p<0.001), and had higher obesity prevalence (52.3% v 36.8%, p=0.017). Females had poorer asthma control assessed by ACQ6 (p=0.010) and were more likely to have depression (42% v 27%; p=0.006), anxiety (36 % v 25%; p=0.039), dysfunctional breathing (60% v 42%; p=0.001) and vocal cord dysfunction (20% v 10%; p=0.023). FeNO, atopy, total IgE and fungal sensitisation did not differ by sex. Males demonstrated a greater reduction in FEV1 (p=0.029). Post bronchodilator spirometry was obstructive in males (post BD FEV1/FVC 62.05) but not females (post BD FEV1/FVC 70.68) (p<0.001), with greater small airways obstruction (Post BD FEF 25-75%= 41.95% predicted in males v 55.40 in females; p<0.001). Conclusion: Some core characteristics of difficult asthma differ by sex supporting the need for sex-specific stratified treatment approache

The Detrimental clinical associations of anxiety and depression with difficult asthma outcomes

Difficult asthma describes asthma in which comorbidities, inadequate treatment, suboptimal inhaler technique and/or poor adherence impede good asthma control. The association of anxiety and depression with difficult asthma outcomes (exacerbations, hospital admissions, asthma control, etc.) is unclear. This study assessed the clinical associations of anxiety and depression with difficult asthma outcomes in patients with a specialist diagnosis of difficult asthma. Using real-world data, we retrospectively phenotyped patients from the Wessex Asthma Cohort of Difficult Asthma (N = 441) using clinical diagnoses of anxiety and depression against those without anxiety or depression (controls). Additionally, we stratified patients by severity of psychological distress using the Hospital Anxiety and Depression Scale (HADS). We found that depression and/or anxiety were reported in 43.1% of subjects and were associated with worse disease-related questionnaire scores. Each psychological comorbidity group showed differential associations with difficult asthma outcomes. Anxiety alone (7.9%) was associated with dysfunctional breathing and more hospitalisations [anxiety, median (IQR): 0 (2) vs. controls: 0 (0)], while depression alone (11.6%) was associated with obesity and obstructive sleep apnoea. The dual anxiety and depression group (23.6%) displayed multimorbidity, worse asthma outcomes, female predominance and earlier asthma onset. Worse HADS-A scores in patients with anxiety were associated with worse subjective outcomes (questionnaire scores), while worse HADS-D scores in patients with depression were associated with worse objective (ICU admissions and maintenance oral corticosteroid requirements) and subjective outcomes. In conclusion, anxiety and depression are common in difficult asthma but exert differential detrimental effects. Difficult asthma patients with dual anxiety and depression experience worse asthma outcomes alongside worse measures of psychological distress. There is a severity-gradient association of HADS scores with worse difficult asthma outcomes. Collectively, our findings highlight the need for holistic, multidisciplinary approaches that promote early identification and management of anxiety and depression in difficult asthma patients.</p

Associations of breathing pattern disorder and Nijmegen score with clinical outcomes in difficult-to-treat asthma

Background: breathing pattern disorder (BPD) reflects altered biomechanical patterns of breathing that drive breathing difficulty and commonly accompanies difficult-to-treat asthma. Diagnosis of BPD has no gold standard, but Nijmegen Questionnaire (NQ) &gt;23 is commonly used.Objectives: we sought to advance clinical characterisation of BPD and better understand clinical utility of NQ in difficult asthma, in patients from the Wessex AsThma CoHort of difficult asthma (WATCH) study.Methods: association between demographic and clinical factors in difficult asthma and BPD, ascertained by clinical diagnosis (yes/no, n=476), by NQ scores (≤23: normal (no suggestion of BPD) and &gt;23: abnormal (suggested BPD), n=372, as well as the continuous raw NQ scores) were assessed in univariate models to identify significant risk factors associated with the three BPD outcomes. For the clinician-diagnosed and NQ-based BPD, associations of continuous factors were assessed using independent samples t-test or Mann-Whitney U test as appropriate for the data distribution or by Spearman correlation test. Dichotomous associations were evaluated using chi-squared tests. Multivariable logistic (dichotomous outcomes) and linear regression models (continuous outcomes) were developed to identify predictive factors associated with clinician-diagnosed and NQ-based BPD, dichotomous and continuous. Patients with data on NQ scores were grouped into NQ quartiles (low, moderate, high, and very high). The patterns of association of the quartiles with four health-related questionnaire outcomes were assessed using linear regression analyses.Results: multivariable regression identified that clinically diagnosed BPD was associated with female sex (OR 1.85; 95% CI 1.07, 3.20), comorbidities (rhinitis (OR 2.46; 95% CI 1.45, 4.17), GORD (OR 2.77; 95% CI 1.58, 4.84), ILO (OR 4.37; 95% CI 2.01, 9.50) and any psychological co-morbidity (OR 1.86; 95% CI 1.13, 3.07)) and healthcare usage (exacerbations (OR 1.07; 95% CI 1.003, 1.14) and previous ICU admissions (OR 2.03; 95% CI 1.18, 3.47)). Abnormal NQ-based BPD diagnosis was associated with history of eczema (OR 1.83; 95% CI 1.07, 3.14), GORD (OR 1.94; 95% CI 1.15, 3.27) or any psychological comorbidity (OR 4.29; 95% CI 2.64, 6.95) at multivariable regression. Differences between clinical and NQ-based BPD traits were also found with 42% discordance in BPD-state between these definitions. Multivariable linear regression analysis with NQ as a continuous outcome showed positive association with worse asthma outcomes (admission to ICU, p=0.037), different phenotypic traits (female sex p=0.001, ever smoker, p=0.025)) and greater multimorbidity (GORD, p=0.002, sleep apnoea, p=0.040, any psychological comorbidity, p&lt;0.0001).Conclusion: BPD is associated with worse health outcomes and negative health impacts in difficult asthma within a multimorbidity disease model. It therefore merits better recognition and prompt treatment. Clinical diagnosis and NQ offer different perspectives on BPD, so this goal may be best addressed by considering clinical features alongside magnitude of NQ