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Standardized exercise training is feasible, safe, and effective in pulmonary arterial and chronic thromboembolic pulmonary hypertension: results from a large European multicentre randomized controlled trial.

Centre for Pulmonary Hypertension, Thoraxklinik Heidelberg gGmbH at Heidelberg University Hospital, Translational Lung Research Center Heidelberg (TLRC), German Center for Lung Research (DZL), Röntgenstraße 1, D-69126 Heidelberg, Germany. Scottish Pulmonary Vascular Unit, Golden Jubilee National Hospital, Glasgow, UK. Laboratory for Molecular Diagnostics, Institute of Human Genetics, Heidelberg University, Heidelberg, Germany. Rehabilitation Center Koenigstuhl, Heidelberg, Germany. Clinic of Pulmonology, University Hospital and University of Zurich, Zurich, Switzerland. Cardiac Rehabilitation Department, IRCCS Maugeri Clinical Scientific Institutes, Milan, Italy. Divisione di Cardiologia, Fondazione IRCCS Policlinico S Matteo, Pavia, Italy. Competence Centre of Pulmonary Hypertension, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania. Faculty of Medicine, Institute of Clinical Medicine, Vilnius University, Vilnius, Lithuania. Department of Translational Medical Sciences, "Federico II" University, Naples, Italy. Department of Clinical Medicine and Surgery, "Federico II" University, Naples, Italy. Department of Cardiovascular Imaging, IRCCS S.D.N., Naples, Italy. Division of Pulmonology, Department of Internal Medicine, Medical University of Graz, Graz, Austria. Ludwig Boltzmann Institute for Lung Vascular Research, Graz, Austria. Department of Pulmonary Medicine, Hospital Clinic-IDIBAPS, University of Barcelona, Barcelona and Biomedical Research Networking Center on Respiratory Diseases (CIBERES), Spain. Research and Development, Ciro, Horn, Netherlands. Department of Respiratory Medicine, Maastricht University Medical Centre (MUMC+), Maastricht, The Netherlands. NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht, The Netherlands. REVAL-Rehabilitation Research Center, BIOMED-Biomedical Research Institute, Faculty of Rehabilitation Sciences, Hasselt University, Diepenbeek, Belgium. Department of Research and Education, CIRO, Horn, The Netherlands. Department of Pulmonology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, VU University Medical Center, Amsterdam, The Netherlands. Department of Internal Medicine, Hospital Geral de Santo António, Porto, Portugal. Centro de Rehabilitação do Norte/Centro Hospitalar Vila Nova de Gaia Espinho, Porto, Portugal. Department of Pneumology, University Hospital Leuven, Leuven, Belgium. Department of Rehabilitation Sciences, KU Leuven - University of Leuven, Leuven, Belgium. Department of Rehabilitation Sciences, Ghent University, Ghent, Belgium. Department of Cardiology, Antonio Carderelli Hospital, Naples, Italy.

European heart journal. 2021;(23):2284-2295
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Abstract

AIMS: This prospective, randomized, controlled, multicentre study aimed to evaluate efficacy and safety of exercise training in patients with pulmonary arterial (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). METHODS AND RESULTS For the first time a specialized PAH/CTEPH rehabilitation programme was implemented in 11 centres across 10 European countries. Out of 129 enrolled patients, 116 patients (58 vs. 58 randomized into a training or usual care control group) on disease-targeted medication completed the study [85 female; mean age 53.6 ± 12.5 years; mean pulmonary arterial pressure 46.6 ± 15.1 mmHg; World Health Organization (WHO) functional class II 53%, III 46%; PAH n = 98; CTEPH n = 18]. Patients of the training group performed a standardized in-hospital rehabilitation with mean duration of 25 days [95% confidence interval (CI) 17-33 days], which was continued at home. The primary endpoint, change of 6-min walking distance, significantly improved by 34.1 ± 8.3 m in the training compared with the control group (95% CI, 18-51 m; P < 0.0001). Exercise training was feasible, safe, and well-tolerated. Secondary endpoints showed improvements in quality of life (short-form health survey 36 mental health 7.3 ± 2.5, P = 0.004), WHO-functional class (training vs. control: improvement 9:1, worsening 4:3; χ2P = 0.027) and peak oxygen consumption (0.9 ± 0.5 mL/min/kg, P = 0.048) compared with the control group. CONCLUSION This is the first multicentre and so far the largest randomized, controlled study on feasibility, safety, and efficacy of exercise training as add-on to medical therapy in PAH and CTEPH. Within this study, a standardized specialized training programme with in-hospital start was successfully established in 10 European countries.

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