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      Telerehabilitation versus traditional centre-based pulmonary rehabilitation for people with chronic respiratory disease: protocol for a randomised controlled trial

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          Abstract

          Background

          Pulmonary rehabilitation is an effective therapeutic intervention for people with chronic respiratory disease. However, fewer than 5% of eligible individuals receive pulmonary rehabilitation on an annual basis, largely due to limited availability of services and difficulties associated with travel and transport. The Rehabilitation Exercise At Home (REAcH) study is an assessor-blinded, multi-centre, randomised controlled equivalence trial designed to compare the efficacy of home-based telerehabilitation and traditional centre-based pulmonary rehabilitation in people with chronic respiratory disease.

          Methods

          Participants will undertake an 8-week group-based pulmonary rehabilitation program of twice-weekly supervised exercise training, either in-person at a centre-based pulmonary rehabilitation program or remotely from their home via the Internet. Supervised exercise training sessions will include 30 min of aerobic exercise (cycle and/or walking training). Individualised education and self-management training will be delivered. All participants will be prescribed a home exercise program of walking and strengthening activities.

          Outcomes will be assessed by a blinded assessor at baseline, after completion of the intervention, and 12-months post intervention. The primary outcome is change in dyspnea score as measured by the Chronic Respiratory Questionnaire – dyspnea domain (CRQ-D). Secondary outcomes will evaluate the efficacy of telerehabilitation on 6-min walk distance, endurance cycle time during a constant work rate test, physical activity and quality of life. Adherence to pulmonary rehabilitation between the two models will be compared. A full economic analysis from a societal perspective will be undertaken to determine the cost-effectiveness of telerehabilitation compared to centre-based pulmonary rehabilitation.

          Discussion

          Alternative models of pulmonary rehabilitation are required to improve both equity of access and patient-related outcomes. This trial will establish whether telerehabilitation can achieve equivalent improvement in outcomes compared to traditional centre-based pulmonary rehabilitation. If efficacious and cost-effective, the proposed telerehabilitation model is designed to be rapidly deployed into clinical practice.

          Trial registration

          Clinical trial registered with the Australian and New Zealand Clinical Trials Register at ( ACTRN12616000360415). Registered 21 March 2016.

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          Most cited references37

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          Measurement of health status. Ascertaining the minimal clinically important difference.

          In recent years quality of life instruments have been featured as primary outcomes in many randomized trials. One of the challenges facing the investigator using such measures is determining the significance of any differences observed, and communicating that significance to clinicians who will be applying the trial results. We have developed an approach to elucidating the significance of changes in score in quality of life instruments by comparing them to global ratings of change. Using this approach we have established a plausible range within which the minimal clinically important difference (MCID) falls. In three studies in which instruments measuring dyspnea, fatigue, and emotional function in patients with chronic heart and lung disease were applied the MCID was represented by mean change in score of approximately 0.5 per item, when responses were presented on a seven point Likert scale. Furthermore, we have established ranges for changes in questionnaire scores that correspond to moderate and large changes in the domains of interest. This information will be useful in interpreting questionnaire scores, both in individuals and in groups of patients participating in controlled trials, and in the planning of new trials.
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            Standards for the diagnosis and treatment of patients with COPD: a summary of the ATS/ERS position paper

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              An Official American Thoracic Society/European Respiratory Society Policy Statement: Enhancing Implementation, Use, and Delivery of Pulmonary Rehabilitation.

              Pulmonary rehabilitation (PR) has demonstrated physiological, symptom-reducing, psychosocial, and health economic benefits for patients with chronic respiratory diseases, yet it is underutilized worldwide. Insufficient funding, resources, and reimbursement; lack of healthcare professional, payer, and patient awareness and knowledge; and additional patient-related barriers all contribute to the gap between the knowledge of the science and benefits of PR and the actual delivery of PR services to suitable patients.
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                Author and article information

                Contributors
                n.cox@latrobe.edu.au
                christine.mcdonald@austin.org.au
                Jennifer.alison@sydney.edu.au
                ajay.mahal@unimelb.edu.au
                r_wootton@pobox.com
                catherine.hill@austin.org.au
                j.bondarenko@alfred.org.au
                heather.macdonald@whcg.org.au
                p.ohalloran@latrobe.edu.au
                paolo.zanaboni@ehealthresearch.no
                clak@unimelb.edu.au
                deidre.rennick@whcg.org.au
                kaye.borgelt@wwhs.net.au
                a.burge@latrobe.edu.au
                a.lahham@latrobe.edu.au
                b.wageck@latrobe.edu.au
                hayley.crute@whcg.org.au
                pawel.czupryn@wwhs.net.au
                amanda.nichols@monashhealth.org
                a.holland@latrobe.edu.au
                Journal
                BMC Pulm Med
                BMC Pulm Med
                BMC Pulmonary Medicine
                BioMed Central (London )
                1471-2466
                15 May 2018
                15 May 2018
                2018
                : 18
                : 71
                Affiliations
                [1 ]ISNI 0000 0001 2342 0938, GRID grid.1018.8, Discipline of Physiotherapy, La Trobe University and Institute for Breathing and Sleep, , La Trobe University, ; Melbourne, VIC Australia
                [2 ]GRID grid.410678.c, Department of Respiratory Medicine Austin Health; Institute for Breathing and Sleep and University of Melbourne, , Austin Health, ; Heidelberg, VIC Australia
                [3 ]ISNI 0000 0004 1936 834X, GRID grid.1013.3, Discipline of Physiotherapy, University of Sydney and Sydney Local Health District, , University of Sydney, ; Lidcombe, NSW Australia
                [4 ]ISNI 0000 0001 2179 088X, GRID grid.1008.9, The Nossal Institute for Global Health, , The University of Melbourne, ; Melbourne, VIC Australia
                [5 ]ISNI 0000 0004 4689 5540, GRID grid.412244.5, Norwegian Center for E-health Research, , University Hospital of North Norway, ; Tromsø, Norway
                [6 ]GRID grid.410678.c, Physiotherapy Department Austin Health and Institute for Breathing and Sleep, , Austin Health, ; Heidelberg, VIC Australia
                [7 ]ISNI 0000 0004 0432 5259, GRID grid.267362.4, Physiotherapy Department, , Alfred Health, ; Prahran, VIC Australia
                [8 ]Wimmera Health Care Group, Horsham, VIC Australia
                [9 ]ISNI 0000 0001 2342 0938, GRID grid.1018.8, School of Psychology and Public Health, , La Trobe University, ; Melbourne, VIC Australia
                [10 ]ISNI 0000 0001 2179 088X, GRID grid.1008.9, Melbourne Networked Society Institute, , University of Melbourne, ; Melbourne, VIC Australia
                [11 ]West Wimmera Health Service, Nhill, VIC Australia
                [12 ]ISNI 0000 0001 2342 0938, GRID grid.1018.8, Discipline of Physiotherapy, La Trobe University; Department of Physiotherapy, Alfred Health and Institute for Breathing and Sleep, , La Trobe University, ; Melbourne, VIC Australia
                [13 ]ISNI 0000 0001 2342 0938, GRID grid.1018.8, Discipline of Physiotherapy, , La Trobe University, ; Melbourne, VIC Australia
                [14 ]ISNI 0000 0000 9295 3933, GRID grid.419789.a, Monash Health, ; Clayton, VIC Australia
                Author information
                http://orcid.org/0000-0002-6977-1028
                Article
                646
                10.1186/s12890-018-0646-0
                5952573
                29764393
                e1d1571c-3ada-4395-935d-8e87c4ef04f8
                © The Author(s). 2018

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 9 November 2017
                : 8 May 2018
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000925, National Health and Medical Research Council;
                Award ID: 1101616
                Award ID: 1119970
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2018

                Respiratory medicine
                chronic obstructive pulmonary disease,pulmonary rehabilitation,telerehabilitation,telehealth,exercise,respiratory disease,interstitial lung disease,bronchiectasis,asthma

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