The effects of a pragmatic exercise intervention in people with multiple sclerosis.

?Background: People with multiple sclerosis (PwMS) are less physically active than the general population. Moderate intensity exercise is likely to be safe and may provide an effective intervention for improving health outcomes for people with mild-to-moderate disability from MS. A robustly designed trial, using a pragmatic approach constructed to be cost-effective and elicit long-lasting behaviour change is required to influence health care practice.Objectives:To determine the feasibility of a pragmatic exercise intervention for PwMS and to determine if this type of intervention can provide a cost effective solution to improving health outcomes and increasing exercise and physical activity at up to nine months follow-up in PwMS compared with usual care alone.Methods: We initially conducted a feasibility randomised controlled trial, recruiting a voluntary sample of 30 PwMS (male n = 4, female n = 26; mean age 40 years; range 24 to 49 years; Expanded Disability Status Scale (EDSS) 0.0 to 5.5). Results from which informed the design of a large-scale randomised controlled trial (RCT). A total of 120 PwMS (male n = 34, female n = 86; mean age 46 years; range 19 to 65 years; EDSS 1.0 to 6.5) were then recruited to a three month exercise intervention (two supervised and one home-based session for first six weeks; one supervised and two home-based session for the final six weeks) plus usual care or usual care alone. Cognitive behavioural strategies were used to promote long-term behaviour change. The primary outcome was self-reported exercise behaviour change (Godin Leisure Time Exercise Questionnaire (GLTEQ)). Secondary outcomes included clinical, functional and quality-of- life (MSQol-54) measures.Results: The feasibility trial demonstrated that attrition was low (6.7% at immediate follow-up and 20% at three months follow-up) and compliance was high (> 75% of all sessions). The main trial reported significant improvements in self-reported exercise behaviour (p = 0.01), fatigue (p < 0.0001) and many MSQol-54 domains (p < 0.03). Only the significant improvements in overall quality of life (p = 0.001), and the sub-domains of emotional wellbeing (p = 0.01) and social function (p = 0.004) were maintained at the nine months follow-up. The probability of the intervention being cost-effective was 0.75 at the threshold of &pound;20,000 per quality adjusted life year (QALY).Conclusion: This pragmatic intervention was not only feasible, but outcomes from the main trial suggest that it is highly likely to be cost effective, leading to improved self-reported exercise behaviour, fatigue and a sustained enhancement of health-related quality of life. This provides a strong evidence base to influence the prescription of exercise into the treatment pathway for PwMS within the NHS

Attitudes to and perceptions of workplace health promotion amongst employees from ethnic minorities in the UK: A scoping review.

BACKGROUND: Ethnic minorities make up approximately 14% of the UK workforce. Despite the disproportionate burden of ill-health amongst ethnic minorities, and the increased interest in Diversity, Equity &amp; Inclusion (DE&I) in the workplace, workplace health and wellbeing interventions are still most often designed for the ethnic majority. OBJECTIVE: The purpose of this scoping review was to explore the depth and breadth of evidence on the attitudes to and perceptions of health and wellbeing interventions in the workplace within ethnic minority groups in the UK, and to identify gaps in evidence that would provide direction for future research needs. METHODS: A scoping review with quality appraisal was undertaken, supplemented by a review of grey literature and a narrative review exploring related evidence from the knowledge bases related to community and cultural adaptation. RESULTS: Only three peer-reviewed studies met inclusion criteria, preventing broad conclusions. 14 papers from the community and cultural adaptation literature provided additional information about how health promotion may be approached effectively in the workplace, including the importance of culturally sensitive, people-centred design, and the use of established adaptation frameworks. CONCLUSION: The literature suggests a need for improvements in four key areas: (1) reporting of ethnic minorities in data relating to workplace health and wellbeing research, (2) more thorough review of perceptions and attitudes of ethnic minority workers in the UK, (3) design of culturally appropriate interventions that are tested for impact, and (4) testing of the effectiveness of culturally adapted interventions

The effects of exercise on cardiometabolic outcomes in women with polycystic ovary syndrome not taking the oral contraceptive pill: protocol for a systematic review and meta-analysis

Polycystic ovary syndrome (PCOS) is the most common endocrinopathy, affecting 4–12% of reproductive-aged women. Women with PCOS often exhibit many metabolic abnormalities that are associated with an increased cardiovascular disease (CVD) risk, independent of obesity. Exercise interventions from 12 to 24 weeks have been shown to have positive effects on blood lipid profile, ovulation and insulin resistance in women with PCOS. However, no consensus on which exercise interventions are effective (i.e. duration, type of exercise, frequency), including for different phenotypes, currently exists. The aim of this systematic review and meta-analysis is to define effective types of exercise interventions to improve cardiometabolic profile, across the range of phenotypes of PCOS. Methods We will conduct electronic database searches, including randomised-controlled trials (RCT), quasi-RCT and clinical trials. Primary outcomes sought will be lipid profile, carotid-intima media thickness, fasting blood glucose, %HbA1c, blood pressure, waist circumference, waist-to-hip ratio, abdominal adiposity and inflammation markers. Secondary outcomes sought will be free and total testosterone, sex hormone binding globulin and insulin resistance. The Cochrane Risk Assessment Tool will be used to assess study quality. Data will be analysed in RevMan. Analysis of heterogeneity will be undertaken using the I2 statistic. Significant heterogeneity will be explored, and sensitivity analyses carried out as appropriate. A subgroup analysis based on androgen profile will be undertaken if data are sufficient. Discussion A large proportion of women are affected by PCOS. It is prudent to examine how CVD risk can be mitigated in this high-risk population, and this review aims to provide evidence-driven recommendations on the types of exercise interventions that are effective for this. The review will seek to provide recommendations regarding type, frequency and duration of exercise interventions to improve cardiometabolic profile in PCOS. The subgroup analysis may be able to highlight difference in intervention effects between normo-androgenic and hyper-androgenic profile. Limitations include heterogeneity across studies and a scarcity of clinical trials involving a PCOS control group not undertaking any intervention

The effects of physical exercise on cardiometabolic outcomes in women with polycystic ovary syndrome not taking the oral contraceptive pill: a systematic review and meta-analysis

Purpose: Women with polycystic ovary syndrome (PCOS) exhibit many metabolic abnormalities that are associated with an increased cardiovascular disease risk. Exercise may promote improvements in lipid profile and insulin sensitivity in women with PCOS. There is however, a knowledge gap on the optimal dose of exercise, regarding duration, intensity, type, and frequency of exercise. The aim of this systematic review and meta-analysis was to define effective types of exercise to improve cardiometabolic profile in PCOS. Methods: We included randomised controlled trials (RCT), quasi-RCT, and controlled clinical trials focusing on reproductive-aged women diagnosed with PCOS. Eligible interventions included those with at least two weeks of supervised exercise sessions. Primary outcomes were blood lipids, blood glucose, blood pressure, measures of abdominal adiposity, and inflammation markers. Secondary outcomes were total and free testosterone, sex hormone binding globulin, and measures of insulin resistance. Nine electronic databases were searched from inception to present for English language publications. The Cochrane Risk Assessment tool was used to assess bias in the included studies. Outcomes were quantitatively synthesised and a meta- analysis was performed. Pooled effect estimates and 95% confidence intervals were presented. Results: This systematic review identified three trials, including 231 participants with PCOS that examined the effect of structured, supervised exercise on cardiometabolic outcomes. Analysis of pooled data indicated statistical favourable effects of exercise on total cholesterol, fasting glucose, waist circumference and waist-to-hip ratio, systolic blood pressure, C-reactive protein, total testosterone, and sex hormone binding globulin using post-intervention scores. Conclusions: Moderate aerobic exercise interventions ≥3 months in duration, with a frequency of 3/week for at least 30-minutes, may have favourable effects on various cardiometabolic risk factors in women with PCOS. However, results should be interpreted with caution. Many of the outcomes were based on studies with serious methodological limitations, and only one "gold-standard" RCT was identified

Pragmatic intervention for increasing self-directed exercise behaviour and improving important health outcomes in people with multiple sclerosis : a randomised controlled trial

Background: Exercise programmes that can demonstrate evidence of long-lasting clinical effectiveness are needed forpeople with multiple sclerosis (PwMS). Objective: The objective of this study was to assess the effects of a practically implemented exercise programme onself-directed exercise behaviour and important health outcomes in PwMS to nine months of follow-up. Methods: We conducted a parallel-arm, randomised controlled trial: 120 PwMS (Expanded Disability Status Scale (EDSS) 1.0-6.5) randomised to a three-month exercise intervention plus usual care, or usual care only. Two supervised plus one homeexercisesession (weeks 1-6) were followed by one supervised and two home-exercise sessions (weeks 7-12). Cognitivebehaviouraltechniques promoted long-term exercise behaviour change. Outcomes were blindly assessed at baseline and atthree and nine months after randomisation. The primary outcome was self-reported exercise behaviour (Godin Leisure TimeExercise Questionnaire (GLTEQ)). Secondary outcomes included fatigue and health-related quality of life (HRQoL). Results: The intervention increased self-reported exercise (9.6 points; 95% CI: 2.0 to 17.3 points; p = 0.01) andimproved fatigue (p<0.0001) and many HRQoL domains (p≤0.03) at three months. The improvements in emotionalwell-being (p = 0.01), social function (p = 0.004) and overall quality of life (p = 0.001) were sustained for nine months. Conclusion: This pragmatic approach to implementing exercise increases self-reported exercise behaviour, improves fatigue and leads to a sustained enhancement of HRQoL domains in PwMS

Qualitative investigation of exercise perceptions and experiences in people with multiple sclerosis before, during, and after participation in a personally tailored exercise program

Objective To undertake a qualitative investigation of exercise perceptions and experiences in people with multiple sclerosis (PwMS) before, during, and after participation in a personally tail ored program designed to promote long-term maintenance of self-directed exercise. Design Focus groups and semistructured telephone interviews. Setting University exercise science department close to the recruiting hospital. Participants PwMS (N=33; mean age ± SD, 47.6±7.9y). Interventions Participants were recruited after participation in a randomized controlled exercise trial; all had been allocated to a 12-week exercise program comprising supervised and self-directed exercise sessions. Main Outcome Measures Exercise perceptions and experiences before, during, and after participation in the program. Results Four themes emerged from the analysis: (1) the transition to inactivity; (2) lack of knowledge and confidence; (3) positive exercise experiences; and (4) perspectives on exercise adherence. Conclusions Lack of confidence and exercise knowledge, coupled with negative perceptions about physical capabilities after an MS diagnosis, are clear barriers to exercise participation in PwMS. These issues are not being adequately addressed as part of the health care pathway or in community settings. Perceptions of improved posture, ability to overcome everyday difficulties, acute mood enhancements during and after exercise, and increased opportunities for social interaction were among the reported benefits of exercise participation. Despite the provision of a personally tailored exercise plan and use of cognitive behavioral strategies, self-directed exercise continued to present challenges to PwMS, and the importance of seeking cost-effective ways to maintain motivational support was implicit in participant responses

Participant recruitment into a randomised controlled trial of exercise therapy for people with multiple sclerosis

The success of a clinical trial is often dependant on whether recruitment targets can be met in the required time frame. Despite an increase in research into the benefits of exercise in people with multiple sclerosis (PwMS), no trial has reported detailed data on effective recruitment strategies for large-scale randomised controlled trials. The main purpose of this report is to provide a detailed outline of recruitment strategies, rates and estimated costs in the Exercise Intervention for Multiple Sclerosis (ExIMS) trial to identify best practices for future trials involving multiple sclerosis (MS) patient recruitment

Exercise for men with prostate cancer : a systematic review and meta-analysis

Context: Exercise could be beneficial for prostate cancer survivors. However, no systematic review across cancer stages and treatment types addressing potential benefits and harms exists to date. Objective: To assess the effects of exercise on cancer-specific quality of life and adverse events in prostate cancer trials. Evidence acquisition: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, AMED, CINAHL, PsycINFO, SPORTDiscus, and PEDro. We also searched grey literature databases, including trial registers. Searches were from database inception to March 2015. Standardised mean differences (SMDs) were calculated for meta-analysis. Evidence synthesis: We included 16 randomised controlled trials (RCTs) involving 1574 men with prostate cancer. Follow-up varied from 8 wk to 12 mo. RCTs involved men with stage I–IV cancers. A high risk of bias was frequently due to problematic intervention adherence. Seven trials involving 912 men measured cancer-specific quality of life. Pooling of the data from these seven trials revealed no significant effect on this outcome (SMD 0.13, 95% confidence interval [CI] –0.08 to 0.34, median follow-up 12 wk). Sensitivity analysis of studies that were judged to be of high quality indicated a moderate positive effect estimate (SMD 0.33, 95% CI 0.08–0.58; median follow-up 12 wk). Similar beneficial effects were seen for cancer-specific fatigue, submaximal fitness, and lower body strength. We found no evidence of benefit for disease progression, cardiovascular health, or sexual function. There were no deaths attributable to exercise interventions. Other serious adverse events (eg, myocardial infarction) were equivalent to those seen in controls. Conclusions: These results support the hypothesis that exercise interventions improve cancer-specific quality of life, cancer-specific fatigue, submaximal fitness, and lower body strength. Patient summary: This review shows that exercise/physical activity interventions can improve quality of life, fatigue, fitness, and function for men with prostate cancer

Barriers and facilitators to implementing workplace health and wellbeing services in the NHS from the perspective of senior leaders and wellbeing practitioners: a qualitative study

Abstract Background The National Health Service (NHS) seems appropriately placed to be an exemplar employer in providing effective and proactive workplace health and wellbeing services for its staff. However, NHS staff sickness absence costs an estimated £2.4 billion. Evidence suggests staff health and wellbeing services delivered in the NHS can improve health, productivity and sickness absence and yet the adoption of these services remains a challenge, with few examples nationally. This research aimed to explore the perceptions of NHS senior leaders and health and wellbeing practitioners regarding barriers and facilitators to implementing workplace health and wellbeing services for staff in the NHS. Methods Semi-structured interviews were conducted with NHS staff, consisting of four senior leaders, four heads of department and three health and wellbeing practitioners in one region of the UK. Interviews were transcribed verbatim and analysed using thematic analysis. Results Themes describe the experience of delivering workplace health and wellbeing services in the NHS, and barriers and facilitators to implementation from senior decision makers. Barriers to implementation of services include; a busy and pressurised environment, financial constraints and reluctance to invest in staff health and wellbeing. Barriers to staff engagement were also reported and include difficulty of access to health and wellbeing services and lack of time. Initiating services were facilitated by financial incentives, a supportive organisational structure and culture that takes a preventative, rather than reactive, approach to staff health and wellbeing. Facilitators to implementing health and wellbeing services include a coherent, strategic approach to implementation, effective communication and advertisement, being creative and innovative with resources and conducting a needs analysis and evaluation before, during and after implementation. Conclusions Barriers to the successful initiation and implementation of health and wellbeing services in the NHS are numerous and range from front-line logistical issues with implementation to high-level strategic and financial constraints. Adopting a strategic and needs-led approach to implementation and ensuring thorough staff engagement are amongst a number of factors that facilitate implementation and help overcome barriers to initiation of wellbeing programmes in the NHS. There is a need for a culture that supports staff health and wellbeing in the NHS

Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570