Rationale Reduced physical activity (PA) in patients with COPD is associated with a poor prognosis. Increasing PA is a key therapeutic target, but thus far few strategies have been found effective in this patient group.
Objectives To investigate the effectiveness of a 12-week semiautomated telecoaching intervention on PA in patients with COPD in a multicentre European randomised controlled trial.
Methods 343 patients from six centres, encompassing a wide spectrum of disease severity, were randomly allocated to either a usual care group (UCG) or a telecoaching intervention group (IG) between June and December 2014. This 12-week intervention included an exercise booklet and a step counter providing feedback both directly and via a dedicated smartphone application. The latter provided an individualised daily activity goal (steps) revised weekly and text messages as well as allowing occasional telephone contacts with investigators. PA was measured using accelerometry during 1 week preceding randomisation and during week 12. Secondary outcomes included exercise capacity and health status. Analyses were based on modified intention to treat.
Main results Both groups were comparable at baseline in terms of factors influencing PA. At 12 weeks, the intervention yielded a between-group difference of mean, 95% CI (lower limit – upper limit; ll-ul) +1469, 95% CI (971 to 1965) steps/day and +10.4, 95% CI (6.1 to 14.7) min/day moderate PA; favouring the IG (all p≤0.001). The change in 6-min walk distance was significantly different (13.4, 95% CI (3.40 to 23.5) m, p<0.01), favouring the IG. In IG patients, an improvement could be observed in the functional state domain of the clinical COPD questionnaire (p=0.03) compared with UCG. Other health status outcomes did not differ.
Conclusions The amount and intensity of PA can be significantly increased in patients with COPD using a 12-week semiautomated telecoaching intervention including a step counter and an application installed on a smartphone.
Trial registration number: NCT02158065.
- Pulmonary Rehabilitation
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Collaborators Mr Papp PROactive study group: Thierry Troosters, Wim Janssens, Paul Van den Brande, Heleen Demeyer, Maarten Spruyt, Matthias Loeckx, Miek Hornikx (Leuven), Michael I Polkey, Nicholas S. Hopkinson, Rebecca Tanner, Yogini Raste, Sara Buttery (London), Ioannis Vogiatzis, Zafeiris Louvaris (Athens), Roberto Rabinovich, Claire Yerramasu, Noah Rubio (Edinburgh), Thys Van der Molen, Corina de Jong, Helma Oosterom (Groningen), Milo Puhan, Anja Frei, Gilbert Buesching, Alexandra Strassman, Martin Frey, Alexander Turk, Stephan Keusch, Alice Zürcher (Zurich), Judith Garcia-Aymerich, Ignasi Serra, Elena Gimeno-Santos (CREAL, Barcelona). PROactive consortium: The PROactive Consortium members are as follows. Nathalie Ivanoff: Almirall, Barcelona, Spain; Niklas Karlsson and Solange Corriol-Rohou: AstraZeneca AB, Mölndal, Sweden; Ian Jarrod: British Lung Foundation, London, UK; Damijen Erzen: Boehringer Ingelheim, Nieder-Ingelheim, Germany; Mario Scuri: Chiesi Farmaceutici S.A. Parma, Italy; Paul McBride: Choice Healthcare Solutions, Hitchin, UK; Nadia Kamel: European Respiratory Society, Lausanne, Switzerland; Margaret Tabberer: GlaxoSmithKline, Uxbridge, UK; Fabienne Dobbels,: Katholieke Universiteit Leuven, Leuven, Belgium; Pim de Boer: Netherlands Asthma Foundation, Amersfoort, The Netherlands; Enkeleida Nikai: UCB, Brussels, Belgium; Bill MacNee: University of Edinburgh, Edinburgh, UK.
Contributors HD, ZL, AF, RR, CdJ, IV, JGA, MIP, MS, RT, CY, and TT contributed to the study protocol and development of the intervention. HD, ZL, AF, RR, CdJ, ML, SB, NR, MS, RT, CY, HO, GB, AS, and IV contributed to the data collection. HD, MP, JGA, IS, and TT contributed to the data analyses and interpretation of the data. HD, NH, MIP, JGA, MP, and TT contributed to the writing of the manuscript. HD, ZL, AF, RR, CdJ, EGS, ML, SB, NR, TVM, NH, IV, MIP, JGA, MP, and TT critically reviewed the manuscript. TT is the guarantor of the study. All authors had full access to all the data in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis.
Funding The PROactive project is funded by the Innovative Medicines Initiative Joint Undertaking (IMU JU) #115011. The Leuven study group was supported by the Flemish Research Foundation (grant # G.0871.13). HD is the recipient of a joint ERS/SEPAR Fellowship (LTRF 2015). ZL is the recipient of an ERS fellowship (LTRF 2016). The Zurich study group was supported by an additional grant of the Lung League Aargau (non-profit organisation) as well as by Swisscom AG who provided 30 sim cards and data usage of up to 1 GB per month. MIP's contribution to this work was supported by the NIHR Respiratory Biomedical Research Unit at the Royal Brompton and Harefield NHS Foundation Trust and Imperial College, London UK who part fund his salary.
Disclaimer The views expressed in this publication are those of the authors and not necessarily those of the NHS, The National Institute for Health Research or the Department of Health. The sponsors did not have any influence on the design, conduct and analysis of the study. TT affirms that the manuscript is an honest, accurate and transparent account of the study being reported. No important aspects of the study have been omitted and the study has been conducted as planned.
Competing interests None declared.
Patient consent Obtained.
Ethics approval This study was approved by the local ethics committee at each centre (Commissie medische ethiek van de universitaire ziekenhuizen KU Leuven (Leuven, S-55919); Medische ethische toetsingscommissie universitair medisch centrum Groningen (Groningen, Metc 2013.362); RES Committee London—South East (London and Edinburgh, 13/LO/1660); Scientific Council of the ‘Sotiria’ General Hospital for Chest Diseases (Athens, 27852/7-10-13); Kantonale Ethikkommission Zürich and Ethikkommission Nordwest- und Zentralschweiz (Zurich, KEK-ZH-Nr. 2013-0469 and EKNZ2014-192, respectively)).
Data sharing statement Full data set and statistical coding are available with the corresponding author.
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