A pulmonary rehabilitation shared decision-making intervention for patients living with COPD: PReSent: protocol for a feasibility study

Background Despite the variety of pulmonary rehabilitation programmes for patients living with COPD, uptake remains low. To improve this, it is recommended that health professionals engage patients in informed decisions about pulmonary rehabilitation. Shared decision-making (SDM) facilitates informed and value-based decision-making between patients and health professionals. This protocol describes the development and evaluation of a complex SDM intervention for patients living with COPD, who are referred for pulmonary rehabilitation, and their pulmonary rehabilitation health professional. Methods and analysis We are developing a complex SDM intervention involving a patient decision aid (PtDA) and a decision coaching workshop. Prior to patient recruitment, pulmonary rehabilitation health professionals will attend the workshop. Upon referral to pulmonary rehabilitation, patients will receive the PtDA to support their decision-making prior to and during their pulmonary rehabilitation assessment with a health professional. The intervention will be evaluated in a one-arm exploratory study to investigate its feasibility and acceptability for patients and health professionals, with an integrated fidelity assessment. The primary outcome is recruitment feasibility, data collection feasibility and intervention fidelity. Secondary outcomes include routine pulmonary rehabilitation data, decisional conflict, patient activation, intervention attendance/attrition and patient and pulmonary rehabilitation health professional experience of the intervention. Quantitative outcomes will be evaluated using the most appropriate statistical test, dependent on the sample distribution. Qualitative outcomes will be evaluated using reflexive thematic analysis. Fidelity will be assessed using the Observer OPTION 5 scale. Conclusion This intervention will provide structure for an informed and values-based decision-making consultation between a patient with COPD and a pulmonary rehabilitation health professional with the potential for optimising pulmonary rehabilitation decision-making

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

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

Supplementary Data: This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content: Data supplement 1 available at: https://bmjopen.bmj.com/highwire/filestream/246974/field_highwire_adjunct_files/0/bmjopen-2021-055513supp001_data_supplement.pdfCopyright © Author(s) (or their employer(s)) 2022. 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.National Institute for Health Research (NIHR) Research for Patient Benefit Programme, grant number (PB-PG-0317-20032) and supported by the NIHR Leicester Biomedical Research Centre (BRC)- Respiratory

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

A self-management programme of activity, coping & education - SPACE FOR COPD in primary care: The protocol for a pragmatic trial

open access articleIntroduction National guidance for chronic obstructive pulmonary disease (COPD) suggests that self-management support be provided for patients. Our institution has developed a standardised, manual-based, supported self- management programme: Self-Management Programme of Activity Coping and Education (SPACE for COPD(C)). SPACE was previously piloted on a 1-2-1 basis, delivered by researchers, to individuals with COPD. Discussions with stakeholders highlighted considerable interest in delivering the SPACE for COPD(C) intervention as a group-based self-management programme facilitated by healthcare professionals (HCPs) in primary care settings. The study aims are to explore the feasibility, acceptability and ef cacy for the intervention to be delivered and supported by HCPs and to examine whether group-based delivery of SPACE for COPD(C), with sustained support, improves patient outcomes following the SPACE for COPD(C) intervention. Methods and analysis A prospective, multi-site, single-blinded randomised controlled trial (RCT) will be conducted, with follow-up at 6 and 9 months. Participants will be randomly assigned to either the control group (usual care) or intervention group (a six-session, group- based SPACE for COPD(C)self-management programme delivered over 5 months). The primary outcome is change in COPD assessment test at 6 months. A discussion session will be conducted with HCPs who deliver the intervention to discuss and gain insight into any potential facilitators/barriers to implementing the intervention in practice. Furthermore, we will conduct semi-structured focus groups with intervention participants to understand feasibility and acceptability. All qualitative data will be analysed thematically. Ethics and dissemination The project has received a favourable opinion from South Hampshire B Research Ethics Committee, REC reference: 14/SC/1169 and full R&D approval from the University Hospitals of Leicester NHS Trust: 152408. Study results will be disseminated through appropriate peer-reviewed journals, national and international respiratory/physiotherapy conferences, via the Collaboration and Leadership in Applied Health Research and Care and through social media

Prevalence of physical frailty, including risk factors, up to 1 year after hospitalisation for COVID-19 in the UK: a multicentre, longitudinal cohort study.

BACKGROUND: The scale of COVID-19 and its well documented long-term sequelae support a need to understand long-term outcomes including frailty. METHODS: This prospective cohort study recruited adults who had survived hospitalisation with clinically diagnosed COVID-19 across 35 sites in the UK (PHOSP-COVID). The burden of frailty was objectively measured using Fried's Frailty Phenotype (FFP). The primary outcome was the prevalence of each FFP group-robust (no FFP criteria), pre-frail (one or two FFP criteria) and frail (three or more FFP criteria)-at 5 months and 1 year after discharge from hospital. For inclusion in the primary analysis, participants required complete outcome data for three of the five FFP criteria. Longitudinal changes across frailty domains are reported at 5 months and 1 year post-hospitalisation, along with risk factors for frailty status. Patient-perceived recovery and health-related quality of life (HRQoL) were retrospectively rated for pre-COVID-19 and prospectively rated at the 5 month and 1 year visits. This study is registered with ISRCTN, number ISRCTN10980107. FINDINGS: Between March 5, 2020, and March 31, 2021, 2419 participants were enrolled with FFP data. Mean age was 57.9 (SD 12.6) years, 933 (38.6%) were female, and 429 (17.7%) had received invasive mechanical ventilation. 1785 had measures at both timepoints, of which 240 (13.4%), 1138 (63.8%) and 407 (22.8%) were frail, pre-frail and robust, respectively, at 5 months compared with 123 (6.9%), 1046 (58.6%) and 616 (34.5%) at 1 year. Factors associated with pre-frailty or frailty were invasive mechanical ventilation, older age, female sex, and greater social deprivation. Frail participants had a larger reduction in HRQoL compared with before their COVID-19 illness and were less likely to describe themselves as recovered. INTERPRETATION: Physical frailty and pre-frailty are common following hospitalisation with COVID-19. Improvement in frailty was seen between 5 and 12 months although two-thirds of the population remained pre-frail or frail. This suggests comprehensive assessment and interventions targeting pre-frailty and frailty beyond the initial illness are required. FUNDING: UK Research and Innovation and National Institute for Health Research

Prevalence of swallow, communication, voice and cognitive compromise following hospitalisation for COVID-19: the PHOSP-COVID analysis

Objective: Identify prevalence of self-reported swallow, communication, voice and cognitive compromise following hospitalisation for COVID-19. Design: Multicentre prospective observational cohort study using questionnaire data at visit 1 (2–7 months post discharge) and visit 2 (10–14 months post discharge) from hospitalised patients in the UK. Lasso logistic regression analysis was undertaken to identify associations. Setting: 64 UK acute hospital Trusts. Participants: Adults aged >18 years, discharged from an admissions unit or ward at a UK hospital with COVID-19. Main outcome measures: Self-reported swallow, communication, voice and cognitive compromise. Results: Compromised swallowing post intensive care unit (post-ICU) admission was reported in 20% (188/955); 60% with swallow problems received invasive mechanical ventilation and were more likely to have undergone proning (p=0.039). Voice problems were reported in 34% (319/946) post-ICU admission who were more likely to have received invasive (p<0.001) or non-invasive ventilation (p=0.001) and to have been proned (p<0.001). Communication compromise was reported in 23% (527/2275) univariable analysis identified associations with younger age (p<0.001), female sex (p<0.001), social deprivation (p<0.001) and being a healthcare worker (p=0.010). Cognitive issues were reported by 70% (1598/2275), consistent at both visits, at visit 1 respondents were more likely to have higher baseline comorbidities and at visit 2 were associated with greater social deprivation (p<0.001). Conclusion: Swallow, communication, voice and cognitive problems were prevalent post hospitalisation for COVID-19, alongside whole system compromise including reduced mobility and overall health scores. Research and testing of rehabilitation interventions are required at pace to explore these issues

Prevalence of physical frailty, including risk factors, up to 1 year after hospitalisation for COVID-19 in the UK: a multicentre, longitudinal cohort study

BACKGROUND: The scale of COVID-19 and its well documented long-term sequelae support a need to understand long-term outcomes including frailty. METHODS: This prospective cohort study recruited adults who had survived hospitalisation with clinically diagnosed COVID-19 across 35 sites in the UK (PHOSP-COVID). The burden of frailty was objectively measured using Fried's Frailty Phenotype (FFP). The primary outcome was the prevalence of each FFP group-robust (no FFP criteria), pre-frail (one or two FFP criteria) and frail (three or more FFP criteria)-at 5 months and 1 year after discharge from hospital. For inclusion in the primary analysis, participants required complete outcome data for three of the five FFP criteria. Longitudinal changes across frailty domains are reported at 5 months and 1 year post-hospitalisation, along with risk factors for frailty status. Patient-perceived recovery and health-related quality of life (HRQoL) were retrospectively rated for pre-COVID-19 and prospectively rated at the 5 month and 1 year visits. This study is registered with ISRCTN, number ISRCTN10980107. FINDINGS: Between March 5, 2020, and March 31, 2021, 2419 participants were enrolled with FFP data. Mean age was 57.9 (SD 12.6) years, 933 (38.6%) were female, and 429 (17.7%) had received invasive mechanical ventilation. 1785 had measures at both timepoints, of which 240 (13.4%), 1138 (63.8%) and 407 (22.8%) were frail, pre-frail and robust, respectively, at 5 months compared with 123 (6.9%), 1046 (58.6%) and 616 (34.5%) at 1 year. Factors associated with pre-frailty or frailty were invasive mechanical ventilation, older age, female sex, and greater social deprivation. Frail participants had a larger reduction in HRQoL compared with before their COVID-19 illness and were less likely to describe themselves as recovered. INTERPRETATION: Physical frailty and pre-frailty are common following hospitalisation with COVID-19. Improvement in frailty was seen between 5 and 12 months although two-thirds of the population remained pre-frail or frail. This suggests comprehensive assessment and interventions targeting pre-frailty and frailty beyond the initial illness are required. FUNDING: UK Research and Innovation and National Institute for Health Research