Self-management programme of activity coping and education-SPACE for COPD(C)-in primary care: a pragmatic randomised trial

INTRODUCTION: We have previously developed a supported self-management programme (SMP): Self-management Programme of Activity, Coping and Education for chronic obstructive pulmonary disease (COPD), which was successfully delivered on an individual basis. Payers expressed an interest in delivering the intervention in groups. AIM: To explore the feasibility, acceptability and clinical effectiveness of the intervention delivered and supported by healthcare professionals (HCPs) in groups within primary care. METHODS: A prospective, single-blinded randomised controlled trial was conducted, with follow-up at 6 and 9 months. Participants were randomly assigned to control (usual care) or intervention (a six-session, group-based SMP delivered over 5 months). The primary outcome was change in COPD Assessment Test (CAT) at 6 months. Semistructured focus groups were conducted with intervention participants to understand feasibility and acceptability. A focus group was conducted with HCPs who delivered the intervention to gain insight into any potential facilitators/barriers to implementing the intervention in practice. All qualitative data were analysed thematically. RESULTS: 193 participants were recruited, (median Medical Research Council (MRC) grade 2). There was no significant difference between the intervention and control group for the primary outcome (CAT). However, an improvement in self-reported patient activation (at 6 and 9 months), knowledge (at 6 months), mastery (at 6 and 9 months) and fatigue (at 6 months), in the intervention group compared with usual care was demonstrated. Qualitative results indicated that the intervention was acceptable to patients who took part in the intervention and HCPs valued the intervention, suggesting it might be best delivered early in the disease process. CONCLUSIONS: A supported self-management intervention is feasible and acceptable when delivered as a group-based intervention, by HCPs in the community

The minimal important difference for the endurance shuttle walk test in individuals with chronic obstructive pulmonary disease following a course of pulmonary rehabilitation

The endurance shuttle walk test (ESWT) is frequently used as an outcome measure for pulmonary rehabilitation (PR). The minimal important difference (MID) for the ESWT after a course of rehabilitation has not been conclusively confirmed in the literature. The aim was to establish the MID for the ESWT following the 6-week PR programme in patients with chronic obstructive pulmonary disease (COPD). Following the completion of the 6-week PR programme, data from 531 participants were included in the analysis to estimate the MID for the ESWT using both anchor-based and distribution-based methods. Mean age (standard deviation (SD)) was 69.4 (9.1) years, 303 male, FEV1/FVC 0.51 (0.16). The baseline incremental shuttle walk test (ISWT) was 217.7 (SD 139.8) metres and ESWT 195.8 (SD 118.8) seconds, which increased to 279.6 (SD 149.5) metres and 537.4 (SD 378.3) seconds, respectively, following PR. The mean change was 61.8 (95% confidence interval (CI) 56.0–67.5) metres for the ISWT and 342.0 (95% CI 312.4–371.6) seconds for the ESWT. The distribution method (0.5 × SD) yielded an MID of 173.7 seconds, the global rating of change scale method yielded a value of 279.2 (95% CI 244.9–313.5) seconds for those rating themselves as ‘slightly improved’ and the ROC method 207 seconds. There was no agreement between the approaches employed. However, we propose that the MID for the ESWT in COPD following a 6-week PR programme is between 174 and 279 seconds

The UK Foot and Ankle COVID-19 National (FAlCoN) audit.

AimsThe primary objective was to determine the incidence of COVID-19 infection and 30-day mortality in patients undergoing foot and ankle surgery during the global pandemic. Secondary objectives were to determine if there was a change in infection and complication profile with changes introduced in practice.MethodsThis UK-based multicentre retrospective national audit studied foot and ankle patients who underwent surgery between 13 January and 31 July 2020, examining time periods pre-UK national lockdown, during lockdown (23 March to 11 May 2020), and post-lockdown. All adult patients undergoing foot and ankle surgery in an operating theatre during the study period were included. A total of 43 centres in England, Scotland, Wales, and Northern Ireland participated. Variables recorded included demographic data, surgical data, comorbidity data, COVID-19 and mortality rates, complications, and infection rates.ResultsA total of 6,644 patients were included. Of the operated patients, 0.52% (n = 35) contracted COVID-19. The overall all-cause 30-day mortality rate was 0.41%, however in patients who contracted COVID-19, the mortality rate was 25.71% (n = 9); this was significantly higher for patients undergoing diabetic foot surgery (75%, n = 3 deaths). Matching for age, American Society of Anesthesiologists (ASA) grade, and comorbidities, the odds ratio of mortality with COVID-19 infection was 11.71 (95% confidence interval 1.55 to 88.74; p = 0.017). There were no differences in surgical complications or infection rates prior to or after lockdown, and among patients with and without COVID-19 infection. After lockdown the COVID-19 infection rate was 0.15% and no patient died of COVID-19.ConclusionCOVID-19 infection was rare in foot and ankle patients even at the peak of lockdown. However, there was a significant mortality rate in those who contracted COVID-19. Overall surgical complications and postoperative infection rates remained unchanged during the period of this audit. Patients and treating medical personnel should be aware of the risks to enable informed decisions. Cite this article: Bone Joint Open 2021;2(4):216-226

SPACE FOR COPD© delivered as a maintenance programme on Pulmonary Rehabilitation discharge::protocol of a randomised controlled trial evaluating the long-term effects on exercise tolerance and mental well-being

Introduction The benefits achieved during pulmonary rehabilitation (PR) are known to be sustained for 6–12 months after the initial programme. Several maintenance trials have been conducted but were heterogeneous in terms of duration, frequency and labour cost. There is no consensus on one best strategy. SPACE FOR COPD (Self-management Programme of Activity, Coping and Education for Chronic Obstructive Pulmonary Disease) is a home-based self-management programme, which has been shown previously to be effective in primary and secondary care settings and is to be tested here as a maintenance programme. The aim is to evaluate the efficacy of the SPACE FOR COPD programme (manual and group sessions), on exercise tolerance and mental well-being, compared with usual care following PR in patients with COPD. Methods and analysis A prospective, multicentre, single-blinded randomised controlled trial requiring 116 participants with a clinical diagnosis of COPD who have finished PR within 4 weeks will be randomised 1:1 to either a usual care group or a SPACE FOR COPD programme group. The intervention comprises a home-based manual and 4, 2-hour group sessions adopting motivational interviewing techniques over 12 months. The primary outcome is endurance capacity measured by the Endurance Shuttle Walking Test at 12 months. Secondary outcomes are: maximal exercise capacity, health-related quality of life, mood, patient activation, physical activity, lung function and healthcare costs. The measures will be taken at baseline, 6 and 12 months. Patient interviews and staff focus groups will be conducted to explore barriers, facilitators and views about the intervention at the end of the study. A framework analysis will be used for the interpretation of qualitative data. Ethics and dissemination The trial was granted ethical approval from Health Research Authority and Health and Care Research Wales (HCRW19/EM/0267 on 10 October 2019). Results will be made available to all stakeholders through a dissemination event, conferences and peer-reviewed publications. Trial registration number ISRCTN30110012

Ventilatory requirements of quadriceps resistance training in people with COPD and healthy controls.

BACKGROUND: It is proposed that resistance training (RT) does not activate the cardiopulmonary system to the same extent as whole-body exercise. This is important for patients with chronic obstructive pulmonary disease (COPD) who are ventilatory limited. OBJECTIVE: The aim was to assess the ventilatory response to an isokinetic quadriceps RT program in people with COPD and healthy controls. DESIGN: Observational. REGISTRATION NUMBER: ISRCTN22764439. SETTING: Outpatient, university teaching hospital. PARTICIPANTS AND OUTCOME MEASURES: People with COPD (n=14) and healthy controls (n=11) underwent breath-by-breath analysis of their ventilation during an RT session (five sets of 30 maximal knee extensions at 180°/sec). Subjects performed a maximal cycle ergometry test (CET) at baseline. Peak ventilation (VE; L/min) and oxygen consumption (VO2; mL/kg/min) were collected. The same system measured VO2 and VE during the RT session. Parameters are presented as a percentage of the maximal CET. Isokinetic workload, symptom scores, heart rate (HR), and oxygen saturation were documented post-training. RESULTS: People with COPD worked at higher percentages of their maximal capacity than controls (mean range between sets 1-5 for VO2 =49.1%-60.1% [COPD], 45.7%-51.43% [controls] and for VE =57.6%-72.2% [COPD], 49.8%-63.6% [controls]), although this was not statistically significant (P>0.1 in all cases). In absolute terms, the difference between groups was only significant for actual VO2 on set 2 (P<0.05). Controls performed more isokinetic work than patients with COPD (P<0.05). Median Borg symptom scores after RT were the same in both groups (3 breathlessness, 13 exertion), no de-saturation occurred, and both groups were training at ≥65% of their maximum HR. CONCLUSION: No statistically significant differences were found between people with COPD and healthy controls for VO2 and VE achieved during training. The symptoms associated with training were within acceptable limits

Whole-body & muscle responses to aerobic exercise training and withdrawal in ageing & COPD

BACKGROUND: Chronic obstructive pulmonary disease (COPD) patients exhibit lower peak oxygen uptake (V′(O(2))(peak)), altered muscle metabolism and impaired exercise tolerance compared with age-matched controls. Whether these traits reflect muscle-level deconditioning (impacted by ventilatory constraints) and/or dysfunction in mitochondrial ATP production capacity is debated. By studying aerobic exercise training (AET) at a matched relative intensity and subsequent exercise withdrawal period we aimed to elucidate the whole-body and muscle mitochondrial responsiveness of healthy young (HY), healthy older (HO) and COPD volunteers to whole-body exercise. METHODS: HY (n=10), HO (n=10) and COPD (n=20) volunteers were studied before and after 8 weeks of AET (65% V′(O(2))(peak)) and after 4 weeks of exercise withdrawal. V′(O(2))(peak), muscle maximal mitochondrial ATP production rate (MAPR), mitochondrial content, mitochondrial DNA (mtDNA) copy number and abundance of 59 targeted fuel metabolism mRNAs were determined at all time-points. RESULTS: Muscle MAPR (normalised for mitochondrial content) was not different for any substrate combination in HO, HY and COPD at baseline, but mtDNA copy number relative to a nuclear-encoded housekeeping gene (mean±sd) was greater in HY (804±67) than in HO (631±69; p=0.041). AET increased V′(O(2))(peak) in HO (17%; p=0.002) and HY (21%; p<0.001), but not COPD (p=0.603). Muscle MAPR for palmitate increased with training in HO (57%; p=0.041) and HY (56%; p=0.003), and decreased with exercise withdrawal in HO (−45%; p=0.036) and HY (−30%; p=0.016), but was unchanged in COPD (p=0.594). mtDNA copy number increased with AET in HY (66%; p=0.001), but not HO (p=0.081) or COPD (p=0.132). The observed changes in muscle mRNA abundance were similar in all groups after AET and exercise withdrawal. CONCLUSIONS: Intrinsic mitochondrial function was not impaired by ageing or COPD in the untrained state. Whole-body and muscle mitochondrial responses to AET were robust in HY, evident in HO, but deficient in COPD. All groups showed robust muscle mRNA responses. Higher relative exercise intensities during whole-body training may be needed to maximise whole-body and muscle mitochondrial adaptation in COPD

Web-based cardiac REhabilitatioN alternative for those declining or dropping out of conventional rehabilitation : results of the WREN feasibility randomised controlled trial

Introduction Cardiac rehabilitation (CR) is typically delivered in hospital-based classes and is recommended to help people reduce their risk of further cardiac events. However, many eligible people are not completing the programme. This study aimed to assess the feasibility of delivering a web-based CR intervention for those who decline/drop out from usual CR. Intervention A web-based CR programme for 6 months, facilitated with remote support. Methods Two-centre, randomised controlled feasibility trial. Patients were randomly allocated to web-based CR/usual care for 6 months. Data were collected to inform the design of a larger study: recruitment rates, quality of life (MacNew), exercise capacity (incremental shuttle walk test) and mood (Hospital Anxiety and Depression Scale). Feasibility of health utility collection was also evaluated. Results 60 patients were randomised (90% male, mean age 62±9 years, 26% of those eligible). 82% completed all three assessment visits. 78% of the web group completed the programme. Quality of life improved in the web group by a clinically meaningful amount (0.5±1.1 units vs 0.2±0.7 units: control). Exercise capacity improved in both groups but mood did not change in either group. It was feasible to collect health utility data. Conclusions It was feasible to recruit and retention to the end of the study was good. The web group reported important improvements in quality of life. This intervention has the opportunity to increase access to CR for patients who would otherwise not attend. Promising outcomes and recruitment suggest feasibility for a full-scale trial. Trial registration number 1072679

Large-scale phenotyping of patients with long COVID post-hospitalization reveals mechanistic subtypes of disease

One in ten severe acute respiratory syndrome coronavirus 2 infections result in prolonged symptoms termed long coronavirus disease (COVID), yet disease phenotypes and mechanisms are poorly understood1. Here we profiled 368 plasma proteins in 657 participants ≥3 months following hospitalization. Of these, 426 had at least one long COVID symptom and 233 had fully recovered. Elevated markers of myeloid inflammation and complement activation were associated with long COVID. IL-1R2, MATN2 and COLEC12 were associated with cardiorespiratory symptoms, fatigue and anxiety/depression; MATN2, CSF3 and C1QA were elevated in gastrointestinal symptoms and C1QA was elevated in cognitive impairment. Additional markers of alterations in nerve tissue repair (SPON-1 and NFASC) were elevated in those with cognitive impairment and SCG3, suggestive of brain–gut axis disturbance, was elevated in gastrointestinal symptoms. Severe acute respiratory syndrome coronavirus 2-specific immunoglobulin G (IgG) was persistently elevated in some individuals with long COVID, but virus was not detected in sputum. Analysis of inflammatory markers in nasal fluids showed no association with symptoms. Our study aimed to understand inflammatory processes that underlie long COVID and was not designed for biomarker discovery. Our findings suggest that specific inflammatory pathways related to tissue damage are implicated in subtypes of long COVID, which might be targeted in future therapeutic trials