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      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)

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          Abstract

          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

          Related collections

          Most cited references 20

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          Pulmonary rehabilitation for chronic obstructive pulmonary disease.

          Widespread application of pulmonary rehabilitation (also known as respiratory rehabilitation) in chronic obstructive pulmonary disease (COPD) should be preceded by demonstrable improvements in function (health-related quality of life, functional and maximal exercise capacity) attributable to the programmes. This review updates the review reported in 2006.
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            Development of a shuttle walking test of disability in patients with chronic airways obstruction.

            The aim was to develop a standardised and externally paced field walking test, incorporating an incremental and progressive structure, to assess functional capacity in patients with chronic airways obstruction. The usefulness of two different shuttle walking test protocols was examined in two separate groups of patients. The initial 10 level protocol (group A, n = 10) and a subsequent, modified, 12 level protocol (group B, n = 10) differed in the number of increments and in the speeds of walking. Patients performed three shuttle walking tests one week apart. Then the performance of patients (group C, n = 15) in the six minute walking test was compared with that in the second (modified) shuttle walking test protocol. Heart rate was recorded during all the exercise tests with a short range telemetry device. The 12 level modified protocol provided a measure of functional capacity in patients with a wide range of disability and was reproducible after just one practice walk; the mean difference between trial 2 v 3 was -2.0 (95% CI -21.9 to 17.9) m. There was a significant relation between the distance walked in the six minute walking test and the shuttle walking test (rho = 0.68) but the six minute walking test appeared to overestimate the extent of disability in some patients. The shuttle test provoked a graded cardiovascular response not evident in the six minute test. Moreover, the maximal heart rates attained were significantly higher for the shuttle walking test than for the six minute test. The shuttle walking test constitutes a standardised incremental field walking test that provokes a symptom limited maximal performance. It provides an objective measurement of disability and allows direct comparison of patients' performance.
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              Unrecognized heart failure in elderly patients with stable chronic obstructive pulmonary disease.

              To establish the prevalence of unrecognized heart failure in elderly patients with a diagnosis of chronic obstructive pulmonary disease, in a stable phase of their disease. In a cross-sectional study, patients >/=65 years of age, classified as having chronic obstructive pulmonary disease by their general practitioner and not known with a cardiologist-confirmed diagnosis of heart failure, were invited to our out-patient clinic. Four hundred and five participants underwent an extensive diagnostic work-up, including medical history and physical examination, followed by chest radiography, electrocardiography, echocardiography, and pulmonary function tests. As reference (i.e. 'gold') standard the consensus opinion of an expert panel was used. The panel based the diagnosis of heart failure on all available results from the diagnostic assessment, guided by the diagnostic principles of the European Society of Cardiology (ESC) for heart failure (i.e., symptoms and echocardiographic systolic and/or diastolic dysfunction). The diagnosis of chronic obstructive pulmonary disease was based on the diagnostic criteria of the Global Initiative (GOLD) for chronic obstructive pulmonary disease. Of 405 participating patients with a diagnosis of chronic obstructive pulmonary disease, 83 (20.5%, 95% CI 16.7-24.8) had previously unrecognized heart failure (42 patients systolic, 41 'isolated' diastolic, and none right-sided heart failure). In total, 244 (60.2%) patients had chronic obstructive pulmonary disease according to the GOLD criteria and 50 (20.5%, 95% CI 15.6-26.1) patients combined with unrecognized heart failure. Unrecognized heart failure is very common in elderly patients with stable chronic obstructive pulmonary disease. Closer co-operation among general practitioners, pulmonologists, and cardiologists is necessary to improve detection and adequate treatment of heart failure in this large patient population.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2019
                16 July 2019
                : 9
                : 7
                Affiliations
                [1 ] departmentNational Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences , Loughborough University , Loughborough, UK
                [2 ] departmentCentre for Exercise and Rehabilitation Sciences, Leicester Biomedical Research Centre-Respiratory , National Institute for Health Research , Leicester, UK
                [3 ] departmentRespiratory Sciences , University of Leicester , Leicester, UK
                [4 ] departmentLeicester Biomedical Research Centre-Lifestyle , National Institute for Health Research , Leicester, UK
                Author notes
                [Correspondence to ] Amy V Jones; a.v.jones@ 123456lboro.ac.uk
                Article
                bmjopen-2019-029387
                10.1136/bmjopen-2019-029387
                6661899
                31315872
                © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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                Categories
                Respiratory Medicine
                Protocol
                1506
                1731
                Custom metadata
                unlocked

                Medicine

                rehabilitation medicine, heart failure, chronic airways disease

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