Clinimetrics of performance-based functional outcome measures for vascular amputees: A systematic review.

BACKGROUND: Objective physical performance-based outcome measures (PerBOMs) are essential tools for the holistic management of people who have had an amputation due to vascular disease. These people are often non-ambulatory, however it is currently unclear which PerBOMs are high quality and appropriate for those who are either ambulatory or non-ambulatory. RESEARCH QUESTION: Which PerBOMs have appropriate clinimetric properties to be recommended for those who have had amputations due to vascular disease ('vascular amputee')? DATA SOURCES: MEDLINE, CINAHL, EMBASE, EMCARE, the Cochrane Library, Cochrane Central Register of Controlled Trials (CENTRAL) and Scopus databases were searched for the terms: "physical performance" or "function", "clinimetric properties", "reliability", "validity", "amputee" and "peripheral vascular disease" or "diabetes". REVIEW METHODS: A systematic review of PerBOMs for vascular amputees was performed following COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology and PRISMA guidelines. The quality of studies and individual PerBOMs was assessed using COSMIN risk of bias and good measurement properties. Overall PerBOM quality was evaluated with a modified GRADE rating. Key clinimetric properties evaluated were reliability, validity, predictive validity and responsiveness. RESULTS: A total of 15,259 records were screened. Forty-eight studies (2650 participants) were included: 7 exclusively included vascular amputees only, 35 investigated validity, 20 studied predictive validity, 23 investigated reliability or internal consistency and 7 assessed responsiveness. Meta-analysis was neither possible nor appropriate for this systematic review in accordance with COSMIN guidelines, due to heterogeneity of the data. Thirty-four different PerBOMs were identified of which only 4 are suitable for non-ambulatory vascular amputees. The Amputee Mobility Predictor no Prosthesis (AMPnoPro) and Transfemoral Fitting Predictor (TFP) predict prosthesis use only. PerBOMs available for assessing physical performance are the One-Leg Balance Test (OLBT) and Basic Amputee Mobility Score (BAMS). CONCLUSION: At present, few PerBOMs can be recommended for vascular amputees. Only 4 are available for non-ambulatory individuals: AMPnoPro, TFP, OLBT and BAMS.

COPD: Providing the right treatment for the right patient at the right time.

Chronic Obstructive Pulmonary Disease (COPD) is a common disease associated with significant morbidity and mortality that is both preventable and treatable. However, a major challenge in recognizing, preventing, and treating COPD is understanding its complexity. While COPD has historically been characterized as a disease defined by airflow limitation, we now understand it as a multi-component disease with many clinical phenotypes, systemic manifestations, and associated co-morbidities. Evidence is rapidly emerging in our understanding of the many factors that contribute to the pathogenesis of COPD and the identification of "early" or "pre-COPD" which should provide exciting opportunities for early treatment and disease modification. In addition to breakthroughs in our understanding of the origins of COPD, we are optimizing treatment strategies and delivery of care that are showing impressive benefits in patient-centered outcomes and healthcare utilization. This special issue of Respiratory Medicine, "COPD: Providing the Right Treatment for the Right Patient at the Right Time" is a summary of the proceedings of a conference held in Stresa, Italy in April 2022 that brought together international experts to discuss emerging evidence in COPD and Pulmonary Rehabilitation in honor of a distinguished friend and colleague, Claudio Ferdinando Donor (1948-2021). Claudio was a true pioneer in the field of pulmonary rehabilitation and the comprehensive care of individuals with COPD. He held numerous leadership roles in in the field, provide editorial stewardship of several respiratory journals, authored numerous papers, statement and guidelines in COPD and Pulmonary Rehabilitation, and provided mentorship to many in our field. Claudio's most impressive talent was his ability to organize spectacular conferences and symposia that highlighted cutting edge science and clinical medicine. It is in this spirit that this conference was conceived and planned. These proceedings are divided into 4 sections which highlight crucial areas in the field of COPD: (1) New concepts in COPD pathogenesis; (2) Enhancing outcomes in COPD; (3) Non-pharmacologic management of COPD; and (4) Optimizing delivery of care for COPD. These presentations summarize the newest evidence in the field and capture lively discussion on the exciting future of treating this prevalent and impactful disease. We thank each of the authors for their participation and applaud their efforts toward pushing the envelope in our understanding of COPD and optimizing care for these patients. We believe that this edition is a most fitting tribute to a dear colleague and friend and will prove useful to students, clinicians, and researchers as they continually strive to provide the right treatment for the right patient at the right time. It has been our pleasure and a distinct honor to serve as editors and oversee such wonderful scholarly work.

Living with frailty and haemodialysis: a qualitative study.

BACKGROUND: Frailty is highly prevalent in people receiving haemodialysis (HD) and is associated with poor outcomes. Understanding the lived experiences of this group is essential to inform holistic care delivery. METHODS: Semi-structured interviews with N = 25 prevalent adults receiving HD from 3 HD units in the UK. Eligibility criteria included a Clinical Frailty Scale (CFS) score of 4-7 and a history of at least one fall in the last 6 months. Sampling began guided by maximum variation sampling to ensure diversity in frailty status; subsequently theoretical sampling enabled exploration of preliminary themes. Analysis was informed by constructivist grounded theory; later we drew upon the socioecological model. RESULTS: Participants had a mean age of 69 ± 10 years, 13 were female, and 13 were White British. 14 participants were vulnerable or mildly frail (CFS 4-5), and 11 moderately or severely frail (CFS 6-7). Participants characterised frailty as weight loss, weakness, exhaustion, pain and sleep disturbance arising from multiple long-term conditions. Participants' accounts revealed: the consequences of frailty (variable function and psychological ill-health at the individual level; increasing reliance upon family at the interpersonal level; burdensome health and social care interactions at the organisational level; reduced participation at the community level; challenges with financial support at the societal level); coping strategies (avoidance, vigilance, and resignation); and unmet needs (overprotection from family and healthcare professionals, transactional health and social care exchanges). CONCLUSIONS: The implementation of a holistic needs assessment, person-centred health and social care systems, greater family support and enhancing opportunities for community participation may all improve outcomes and experience. An approach which encompasses all these strategies, together with wider public health interventions, may have a greater sustained impact. TRIAL REGISTRATION: ISRCTN12840463 .

Inequality in Pulmonary Rehabilitation - The challenges magnified by the COVID-19 pandemic.

The COVID-19 pandemic has served to expose and amplify existing inequalities in chronic respiratory disease and the social determinants of health. In this article, we summarise evidence of existing disparities associated with chronic obstructive pulmonary disease and pulmonary rehabilitation; highlighting limitations of existing data. To reduce health inequalities in pulmonary rehabilitation, there is a need to identify and target factors influencing fair access and personal agency to engage. With consideration of the influence of culture on beliefs, expectations and health behaviours, we propose a renewed approach toward progressively achieving health equity in pulmonary rehabilitation based on principles of cultural safety and adaptation. This is a key priority in improving the quality of life of people living with chronic respiratory disease. Building comprehensive pulmonary rehabilitation service delivery models based on an understanding of the holistic needs of the local population should be a priority for service providers and researchers.

Randomised controlled trial to investigate the use of high-frequency airway oscillations as training to improve dyspnoea (TIDe) in COPD.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is characterised by symptomatic dyspnoea and reduced exercise tolerance, in part as a result muscle weakness, for which inspiratory muscle training (IMT) may be useful. Excess mucus hypersecretion commonly coexists in COPD and may lead to reduce ventilation, further impacting on breathlessness. Devices for sputum clearance may be employed to aid mucus expectoration. This trial aimed to explore the effectiveness of a combined IMT and high-frequency airway oscillating (HFAO) device in the management of dyspnoea. METHODS: This was a double-blinded, randomised sham-controlled trial which recruited symptomatic patients with COPD. Patients were randomised to either a HFAO device (Aerosure) or sham device for 8 weeks, three times a day. The primary outcome was the Chronic Respiratory Questionnaire dyspnoea (CRQ-D) domain. Pre-specified subgroup analyses were performed including those with respiratory muscle weakness, excessive sputum and frequent exacerbators. RESULTS: 104 participants (68% men, mean (SD) age 69.75 years (7.41), forced expiratory volume in 1 s per cent predicted 48.22% (18.75)) were recruited to this study with 96 participants completing. No difference in CRQ-D was seen between groups (0·28, 95% CI -0.19 to 0.75, p=0.24), though meaningful improvements were seen over time in both groups (mean (SD) HFAO 0.45 (0.78), p<0.01; sham 0.73 (1.09), p<0.01). Maximal inspiratory pressure significantly improved in the HFAO group over sham (5.26, 95% CI 0.34 to 10.19, p=0.05). Similar patterns were seen in the subgroup analysis. CONCLUSION: There were no statistical differences between the HFAO and the sham group in improving dyspnoea measured by the CRQ-D. TRIAL REGISTRATION NUMBER: ISRCTN45695543.

Potential for integrating yoga within pulmonary rehabilitation and recommendations of reporting framework.

There is a rising burden of chronic obstructive pulmonary disease (COPD) in India. Pulmonary rehabilitation (PR), is a universally recommended multidisciplinary therapeutic strategy for the management of COPD; however, its needs are unmet. The diversity in the healthcare systems, availability of PR specialists and sociocultural multiformity requires contextualised and innovative PR models. Culturally sensitive elements, such as yoga, have some evidence of a positive impact in the management of COPD. Yoga and PR are based on similar principles with a holistic approach of involving physical activities, behaviour change techniques and psychological support to improve disease outcomes. Arguably the principles of PR and yoga are complementary but there are some important differences in the intensities of activities, exercise types and inclusion of mindfulness in components that must be considered. Components of PR enable aerobic capacity building, strengthening of muscles of the upper and lower extremities and building awareness towards disease management. Yoga, on the other hand, primarily can focus on core strengthening, breathing control, mindfulness and self-awareness. We discuss the potential of integrating the sociocultural appeal of yoga with PR delivered at international standards, and how an integrated approach may lead to optimal referral, uptake and completion.

Physical, cognitive, and mental health impacts of COVID-19 after hospitalisation (PHOSP-COVID): a UK multicentre, prospective cohort study.

BACKGROUND: The impact of COVID-19 on physical and mental health and employment after hospitalisation with acute disease is not well understood. The aim of this study was to determine the effects of COVID-19-related hospitalisation on health and employment, to identify factors associated with recovery, and to describe recovery phenotypes. METHODS: The Post-hospitalisation COVID-19 study (PHOSP-COVID) is a multicentre, long-term follow-up study of adults (aged ≥18 years) discharged from hospital in the UK with a clinical diagnosis of COVID-19, involving an assessment between 2 and 7 months after discharge, including detailed recording of symptoms, and physiological and biochemical testing. Multivariable logistic regression was done for the primary outcome of patient-perceived recovery, with age, sex, ethnicity, body-mass index, comorbidities, and severity of acute illness as covariates. A post-hoc cluster analysis of outcomes for breathlessness, fatigue, mental health, cognitive impairment, and physical performance was done using the clustering large applications k-medoids approach. The study is registered on the ISRCTN Registry (ISRCTN10980107). FINDINGS: We report findings for 1077 patients discharged from hospital between March 5 and Nov 30, 2020, who underwent assessment at a median of 5·9 months (IQR 4·9-6·5) after discharge. Participants had a mean age of 58 years (SD 13); 384 (36%) were female, 710 (69%) were of white ethnicity, 288 (27%) had received mechanical ventilation, and 540 (50%) had at least two comorbidities. At follow-up, only 239 (29%) of 830 participants felt fully recovered, 158 (20%) of 806 had a new disability (assessed by the Washington Group Short Set on Functioning), and 124 (19%) of 641 experienced a health-related change in occupation. Factors associated with not recovering were female sex, middle age (40-59 years), two or more comorbidities, and more severe acute illness. The magnitude of the persistent health burden was substantial but only weakly associated with the severity of acute illness. Four clusters were identified with different severities of mental and physical health impairment (n=767): very severe (131 patients, 17%), severe (159, 21%), moderate along with cognitive impairment (127, 17%), and mild (350, 46%). Of the outcomes used in the cluster analysis, all were closely related except for cognitive impairment. Three (3%) of 113 patients in the very severe cluster, nine (7%) of 129 in the severe cluster, 36 (36%) of 99 in the moderate cluster, and 114 (43%) of 267 in the mild cluster reported feeling fully recovered. Persistently elevated serum C-reactive protein was positively associated with cluster severity. INTERPRETATION: We identified factors related to not recovering after hospital admission with COVID-19 at 6 months after discharge (eg, female sex, middle age, two or more comorbidities, and more acute severe illness), and four different recovery phenotypes. The severity of physical and mental health impairments were closely related, whereas cognitive health impairments were independent. In clinical care, a proactive approach is needed across the acute severity spectrum, with interdisciplinary working, wide access to COVID-19 holistic clinical services, and the potential to stratify care. FUNDING: UK Research and Innovation and National Institute for Health Research.

British Thoracic Society survey of rehabilitation to support recovery of the post-COVID-19 population.

OBJECTIVE: A proportion of those recovering from COVID-19 are likely to have significant and ongoing symptoms, functional impairment and psychological disturbances. There is an immediate need to develop a safe and efficient discharge process and recovery programme. Established rehabilitation programmes are well placed to deliver a programme for this group but will most likely need to be adapted for the post-COVID-19 population. The purpose of this survey was to rapidly identify the components of a post-COVID-19 rehabilitation assessment and elements of a successful rehabilitation programme that would be required to deliver a comprehensive service for those post-COVID-19 to inform service delivery. DESIGN: A survey comprising a series of closed questions and a free-text comment box allowing for a qualitative analysis. SETTING: Online survey. PARTICIPANTS: Multiprofessional clinicians across specialties were invited to take part. RESULTS: 1031 participants responded from a broad range of specialties. There was overwhelming support for an early posthospital discharge recovery programme to advise patients about the management of fatigue (95% agreed/strongly agreed), breathlessness (94%) and mood disturbances (including symptoms of anxiety and depression, 92%). At the time point of 6-8 weeks, an assessment was considered important, focusing on a broad range of possible symptoms and supporting a return to work. Recommendations for the intervention described a holistic programme focusing on symptom management, return of function and return to employment. The free-text comments added depth to the survey and the need 'not to reinvent the wheel' but rather adapt well-established rehabilitation services to individually tailor needs-based care with continued learning for service development. CONCLUSION: The responses indicate a huge interest and the urgent need to establish a programme to support and mitigate the long-term impact of COVID-19 by optimising and individualising existing rehabilitation programmes.

Systematic review of clinical effectiveness, components, and delivery of pulmonary rehabilitation in low-resource settings.

Pulmonary rehabilitation (PR) is a guideline-recommended multifaceted intervention that improves the physical and psychological well-being of people with chronic respiratory diseases (CRDs), though most of the evidence derives from trials in high-resource settings. In low- and middle-income countries, PR services are under-provided. We aimed to review the effectiveness, components and mode of delivery of PR in low-resource settings. Following Cochrane methodology, we systematically searched (1990 to October 2018; pre-publication update March 2020) MEDLINE, EMBASE, CABI, AMED, PUBMED, and CENTRAL for controlled clinical trials of adults with CRD (including but not restricted to chronic obstructive pulmonary disease) comparing PR with usual care in low-resource settings. After duplicate selection, we extracted data on exercise tolerance, health-related quality of life (HRQoL), breathlessness, included components, and mode of delivery. We used Cochrane risk of bias (RoB) to assess study quality and synthesised data narratively. From 8912 hits, we included 13 studies: 11 were at high RoB; 2 at moderate RoB. PR improved functional exercise capacity in 10 studies, HRQoL in 12, and breathlessness in 9 studies. One of the two studies at moderate RoB showed no benefit. All programmes included exercise training; most provided education, chest physiotherapy, and breathing exercises. Low cost services, adapted to the setting, used limited equipment and typically combined outpatient/centre delivery with a home/community-based service. Multicomponent PR programmes can be delivered in low-resource settings, employing a range of modes of delivery. There is a need for a high-quality trial to confirm the positive findings of these high/moderate RoB studies.

Management of Fracture Risk in Patients with Chronic Obstructive Pulmonary Disease (COPD): Building a UK Consensus Through Healthcare Professional and Patient Engagement.

Introduction: Osteoporosis and bone fractures are common in chronic obstructive pulmonary disease (COPD) and contribute significantly to morbidity and mortality. Current national guidance on COPD management recommends addressing bone health in patients, however, does not detail how. This consensus outlines key elements of a structured approach to managing bone health and fracture risk in patients with COPD. Methods: A systematic approach incorporating multifaceted methodologies included detailed patient and healthcare professional (HCP) surveys followed by a roundtable meeting to reach a consensus on what a pathway would look like. Results: The surveys revealed that fracture risk was not always assessed despite being recognised as an important aspect of COPD management by HCPs. The majority of the patients also stated they would be receptive to discussing treatment options if found to be at risk of osteoporotic fractures. Limited time and resource allocation were identified as barriers to addressing bone health during consultations. The consensus from the roundtable meeting was that a proactive systematic approach to assessing bone health should be adopted. This should involve using fracture risk assessment tools to identify individuals at risk, investigating secondary causes of osteoporosis if a diagnosis is made and reinforcing non-pharmacological and preventative measures such as smoking cessation, keeping active and pharmacological management of osteoporosis and medicines management of corticosteroid use. Practically, prioritising patients with important additional risk factors, such as previous fragility fractures, older age and long-term oral corticosteroid use for an assessment, was felt required. Conclusion: There is a need for integrating fracture risk assessment into the COPD pathway. Developing a systematic and holistic approach to addressing bone health is key to achieving this. In tandem, opportunities to disseminate the information and educational resources are also required.

Protocol for a feasibility trial to inform the development of a breathlessness rehabilitation programme for chronic obstructive pulmonary disease and chronic heart failure (the COHERE trial).

INTRODUCTION: Adults with chronic obstructive pulmonary disease (COPD) and chronic heart failure (CHF) commonly suffer from exertional dyspnoea and fatigue. Exercise training is recommended in the management of both diseases, yet many of the outcome measures traditionally reported are disease specific and may not fully acknowledge the multimorbid older adult. Based on our previous research, a breathlessness rehabilitation programme for patients with COPD/CHF or combined disease has been introduced as a service improvement within University Hospital Leicester National Health Service Trust and has amalgamated aspects of cardiac and pulmonary rehabilitation. This has created an opportunity to expand the outcome measures assessed and introduce a holistic approach in a population that share common symptoms. Therefore, this multisite trial will explore the feasibility of collecting novel outcome markers as part of a comprehensive assessment prior to enrolment in a breathlessness rehabilitation programme for participants with COPD and/or CHF. METHODS AND ANALYSIS: The rehabilitation programme consists of 12 sessions, twice weekly, over a 6-week period. In addition to usual rehabilitation outcome measures, the trial will collect measures of future cardiometabolic risk including arterial stiffness, body composition, physical activity/sedentary time, frailty and symptom burden in a comprehensive rehabilitation assessment. The primary outcome measures will centre around feasibility (eg, acceptability of the comprehensive rehabilitation assessment, intervention delivery and the experiences and attitudes of healthcare professionals and participants). Focus groups and interviews will be conducted to further explore barriers and facilitators to the operation and participation in a breathlessness rehabilitation programme and the trial. Thematic analysis will be used for the interpretation of all qualitative data. ETHICS AND DISSEMINATION: The research ethics committee East Midlands Leicester-Central has provided ethical approval for the conduct of this trial. The results of the trial will be disseminated through appropriate conference proceedings and peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN11636308.

The effects and costs of home-based rehabilitation for heart failure with reduced ejection fraction: The REACH-HF multicentre randomized controlled trial.

BACKGROUND: Cardiac rehabilitation improves health-related quality of life (HRQoL) and reduces hospitalizations in patients with heart failure, but international uptake of cardiac rehabilitation for heart failure remains low. DESIGN AND METHODS: The aim of this multicentre randomized trial was to compare the REACH-HF (Rehabilitation EnAblement in CHronicHeart Failure) intervention, a facilitated self-care and home-based cardiac rehabilitation programme to usual care for adults with heart failure with reduced ejection fraction (HFrEF). The study primary hypothesis was that the addition of the REACH-HF intervention to usual care would improve disease-specific HRQoL (Minnesota Living with Heart Failure questionnaire (MLHFQ)) at 12 months compared with usual care alone. RESULTS: The study recruited 216 participants, predominantly men (78%), with an average age of 70 years and mean left ventricular ejection fraction of 34%. Overall, 185 (86%) participants provided data for the primary outcome. At 12 months, there was a significant and clinically meaningful between-group difference in the MLHFQ score of -5.7 points (95% confidence interval -10.6 to -0.7) in favour of the REACH-HF intervention group ( p = 0.025). With the exception of patient self-care ( p < 0.001) there was no significant difference in other secondary outcomes, including clinical events ( p > 0.05) at follow-up compared with usual care. The mean cost of the REACH-HF intervention was £418 per participant. CONCLUSIONS: The novel REACH-HF home-based facilitated intervention for HFrEF was clinically superior in disease-specific HRQoL at 12 months and offers an affordable alternative to traditional centre-based programmes to address current low cardiac rehabilitation uptake rates for heart failure.

Incorporating telemedicine into the integrated care of the COPD patient a summary of an interdisciplinary workshop held in Stresa, Italy, 7-8 September 2017.

This report is a summary of a workshop focusing on using telemedicine to facilitate the integrated care of chronic obstructive pulmonary disease (COPD). Twenty-five invited participants from 8 countries met for one and one-half days in Stresa, Italy on 7-8 September 2017, to discuss this topic. Participants included physiotherapists, nurses, a nurse practitioner, and physicians. While evidence-based data are always at the center of sound inference and recommendations, at this point in time the science behind telemedicine in COPD remains under-developed; therefore, this document reflects expert opinion and consensus. While telemedicine has great potential to expand and improve the care of our COPD patients, its application is still in its infancy. While studies have demonstrated its effectiveness in some patient-centered outcomes, the results are by no means consistently positive. Whereas this tool may potentially reduce health care costs by moving some medical interventions from centralized locations in to patient's home, its cost-effectiveness has had mixed results and telemonitoring has yet to prove its worth in the COPD population. These discordant results should not be unexpected in view of patient complexity and the heterogeneity of telemedicine. This is reflected in the very limited support offered by the National Health Services to a wider application of telemedicine in the integrated care of COPD patients. However, this situation should challenge us to develop the necessary science to clarify the role of telemedicine in the medical management of our patients, providing a better and definitive scientific basis to this approach.

High-Frequency Airway Oscillating Device for Respiratory Muscle Training in Subjects With COPD.

BACKGROUND: COPD is characterized by expiratory flow limitation, which results in symptomatic dyspnea and reduced exercise capacity. Changes in breathing mechanics mean the respiratory muscles are unable to respond to the ventilatory demands, increasing the sensation of dyspnea. A high-frequency oscillating device has been developed to improve dyspnea in patients with COPD. We conducted a feasibility trial to gain insight into the potential for recruitment, retention, and study design for a future randomized controlled trial. METHODS: Symptomatic subjects with COPD were included on the basis of a Medical Research Council (MRC) score ≥ 3 and FEV1/FVC < 0.70). Patients were excluded if they received pulmonary rehabilitation within the last 6 months. The intervention employed the device for 8 weeks, 3 times daily. Clinical outcomes included the MRC score, maximal expiratory and inspiratory pressures (PEmax/PImax), the incremental shuttle walk test (ISWT), and the endurance shuttle walk test (ESWT). RESULTS: We successfully recruited 23 subjects with established COPD (65.2% male, mean age 65 ± 5.03 y, mean % predicted FEV1 43.9 ± 16, mean FEV1/FVC ratio 0.46 ± 0.13, and median [interquartile range] MRC 4 [3-5]). There was a significant change in MRC from 4 to 3 pre to post intervention (P = .003). There was a statistically significant difference in PEmaxP < .008 and PImaxP = .044. There were no significant differences observed in the ISWT or ESWT. CONCLUSIONS: This study design appeared feasible to proceed to a clinical effectiveness trial. The use of the device for 8 weeks showed a significant improvement in PEmax, PImax, and reduced symptomatic dyspnea on the MRC dyspnea score. The results of this study should encourage a randomized controlled trial.

Comparison of a structured home-based rehabilitation programme with conventional supervised pulmonary rehabilitation: a randomised non-inferiority trial.

BACKGROUND: Standardised home-based pulmonary rehabilitation (PR) programmes offer an alternative model to centre-based supervised PR for which uptake is currently poor. We determined if a structured home-based unsupervised PR programme was non-inferior to supervised centre-based PR for participants with COPD. METHODS: A total of 287 participants with COPD who were referred to PR (187 male, mean (SD) age 68 (8.86) years, FEV1% predicted 48.34 (17.92)) were recruited. They were randomised to either centre-based PR or a structured unsupervised home-based PR programme including a hospital visit with a healthcare professional trained in motivational interviewing, a self-management manual and two telephone calls. Fifty-eight (20%) withdrew from the centre-based group and 51 (18%) from the home group. The primary outcome was dyspnoea domain in the chronic respiratory disease questionnaire (Chronic Respiratory Questionnaire Self-Report; CRQ-SR) at 7 weeks. Measures were taken blinded. We undertook a modified intention-to-treat (mITT) complete case analysis, comparing groups according to original random allocation and with complete data at follow-up. The non-inferiority margin was 0.5 units. RESULTS: There was evidence of significant gains in CRQ-dyspnoea at 7 weeks in both home and centre-based groups. There was inconclusive evidence that home-based PR was non-inferior to PR in dyspnoea (mean group difference, mITT: -0.24, 95% CI -0.61 to 0.12, p=0.18), favouring the centre group at 7 weeks. CONCLUSIONS: The standardised home-based programme provides benefits in dyspnoea. Further evidence is needed to definitively determine if the health benefits of the standardised home-based programme are non-inferior or equivalent to supervised centre-based rehabilitation. TRIAL REGISTRATION NUMBER: ISRCTN81189044.

Randomised feasibility trial into the effects of low-frequency electrical muscle stimulation in advanced heart failure patients.

OBJECTIVES: Low-frequency electrical muscle stimulation (LF-EMS) may have the potential to reduce breathlessness and increase exercise capacity in the chronic heart failure population who struggle to adhere to conventional exercise. The study's aim was to establish if a randomised controlled trial of LF-EMS was feasible. DESIGN AND SETTING: Double blind (participants, outcome assessors), randomised study in a secondary care outpatient cardiac rehabilitation programme. PARTICIPANTS: Patients with severe heart failure (New York Heart Association class III-IV) having left ventricular ejection fraction <40% documented by echocardiography were eligible. INTERVENTIONS: Participants were randomised (remotely by computer) to 8 weeks (5×60 mins per week) of either LF-EMS intervention (4 Hz, continuous, n=30) or sham placebo (skin level stimulation only, n=30) of the quadriceps and hamstrings muscles. Participants used the LF-EMS straps at home and were supervised weekly OUTCOME MEASURES: Recruitment, adherence and tolerability to the intervention were measured during the trial as well as physiological outcomes (primary outcome: 6 min walk, secondary outcomes: quadriceps strength, quality of life and physical activity). RESULTS: Sixty of 171 eligible participants (35.08%) were recruited to the trial. 12 (20%) of the 60 patients (4 LF-EMS and 8 sham) withdrew. Forty-one patients (68.3%), adhered to the protocol for at least 70% of the sessions. The physiological measures indicated no significant differences between groups in 6 min walk distance(p=0.13) and quality of life (p=0.55) although both outcomes improved more with LF-EMS. CONCLUSION: Patients with severe heart failure can be recruited to and tolerate LF-EMS studies. A larger randomised controlled trial (RCT) in the advanced heart failure population is technically feasible, although adherence to follow-up would be challenging. The preliminary improvements in exercise capacity and quality of life were minimal and this should be considered if planning a larger trial. TRIAL REGISTRATION NUMBER: ISRCTN16749049.

Cardiovascular risk, chronic obstructive pulmonary disease and pulmonary rehabilitation: Can we learn from cardiac rehabilitation?

Patients with chronic obstructive pulmonary disease (COPD) who participate in pulmonary rehabilitation (PR) often have concomitant cardiovascular disease (CVD), which is a frequently undiagnosed and undertreated comorbidity. CVD contributes to the burden of the disease and is associated with an increased risk for hospitalizations and mortality. Optimizing the diagnosis and management of cardiovascular risk and disease should be considered as part of the holistic approach of PR. In addition, we need to consider similarities and differences in cardiac and PR programs, in order to improve personalized care in patients with both diseases. The current review addresses the burden of CVD in COPD patients who participate in PR, how CVD and its risk factors affect PR and should be managed during PR, and extends on what we can learn of the organization of cardiac rehabilitation programs.

Rehabilitation following hospitalization in patients with COPD: can it reduce readmissions?

Exacerbations of chronic obstructive pulmonary disease (COPD) are one of the commonest causes of emergency hospital admission and are associated with high rates of readmission. Rehabilitation in the peri- and early post-hospitalization setting may counteract the deleterious consequences of an acute hospital admission and target modifiable risk factors for readmission such as physical inactivity, reduced exercise capacity and impaired physical function. Pulmonary rehabilitation in the peri-hospitalization period can improve exercise capacity and health-related quality of life and can also reduce rates of readmission. Consequently, guidelines have recommended the provision of pulmonary rehabilitation in the acute setting. However, recent trials showing less positive results and observational data questioning acceptability may challenge prevailing enthusiasm. This review examines the role of pulmonary rehabilitation in the peri- and early post-hospitalization setting, considering the modifiable risk factors for readmission, the latest evidence regarding rehabilitation in the acute setting, issues around acceptability and uptake, and alternative strategies to help deliver rehabilitation to more patients. The acceptability and effectiveness of pulmonary rehabilitation offered that post-exacerbation could be improved by overcoming issues around the setting, timing and format of rehabilitation approaches, including their integration with self-management interventions.

Nutritional assessment and therapy in COPD: a European Respiratory Society statement.

Nutrition and metabolism have been the topic of extensive scientific research in chronic obstructive pulmonary disease (COPD) but clinical awareness of the impact dietary habits, nutritional status and nutritional interventions may have on COPD incidence, progression and outcome is limited. A multidisciplinary Task Force was created by the European Respiratory Society to deliver a summary of the evidence and description of current practice in nutritional assessment and therapy in COPD, and to provide directions for future research. Task Force members conducted focused reviews of the literature on relevant topics, advised by a methodologist. It is well established that nutritional status, and in particular abnormal body composition, is an important independent determinant of COPD outcome. The Task Force identified different metabolic phenotypes of COPD as a basis for nutritional risk profile assessment that is useful in clinical trial design and patient counselling. Nutritional intervention is probably effective in undernourished patients and probably most when combined with an exercise programme. Providing evidence of cost-effectiveness of nutritional intervention is required to support reimbursement and thus increase access to nutritional intervention. Overall, the evidence indicates that a well-balanced diet is beneficial to all COPD patients, not only for its potential pulmonary benefits, but also for its proven benefits in metabolic and cardiovascular risk.

Skeletal muscle molecular responses to resistance training and dietary supplementation in COPD.

BACKGROUND: Skeletal muscle dysfunction is a systemic feature of chronic obstructive pulmonary disease (COPD), contributing to morbidity and mortality. Physical training improves muscle mass and function in COPD, but the molecular regulation therein is poorly understood. METHODS: Candidate genes and proteins regulating muscle protein breakdown (ubiquitin proteasome pathway), muscle protein synthesis (phosphatidylinositol 3 kinase/Akt/mammalian target of rapamycin pathway), myogenesis (MyoD, myogenin and myostatin) and transcription (FOXO1, FOXO3 and RUNX1) were determined in quadriceps muscle samples taken at four time points over 8 weeks of knee extensor resistance training (RT) in patients with COPD and healthy controls (HCs). Patients with COPD were randomly allocated to receive protein/carbohydrate or placebo supplements during RT. RESULTS: 59 patients with COPD (mean (SD) age 68.0 (9.3) years, forced expiratory volume in 1 s (FEV1) 46.9 (17.8) % predicted) and 21 HCs (66.1 (4.8) years, 105.0 (21.6) % predicted) were enrolled. RT increased lean mass (~5%) and strength (~20%) in all groups. Absolute work done during RT was lower throughout in patients with COPD compared with HCs. RT resulted in increases (from basal) in catabolic, anabolic, myogenic and transcription factor protein expression at 24 h, 4 weeks and 8 weeks of exercise in HCs. This response was blunted in patients with COPD, except for myogenic signalling, which was similar. Nutritional supplementation did not augment functional or molecular responses to RT. CONCLUSIONS: The potential for muscle rehabilitation in response to RT is preserved in COPD. Except for markers of myogenesis, molecular responses to RT are not tightly coupled to lean mass gains but reflect the lower work done during RT, suggesting some caution when identifying molecular targets for intervention. Increasing post-exercise protein and carbohydrate intake is not a prerequisite for a normal training response in COPD.