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.
Grünig ECentre 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.
MacKenzie AScottish Pulmonary Vascular Unit, Golden Jubilee National Hospital, Glasgow, UK.
Peacock AJScottish Pulmonary Vascular Unit, Golden Jubilee National Hospital, Glasgow, UK.
Eichstaedt CACentre 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.
Benjamin NCentre 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.
Nechwatal RRehabilitation Center Koenigstuhl, Heidelberg, Germany.
Ulrich SClinic of Pulmonology, University Hospital and University of Zurich, Zurich, Switzerland.
Saxer SClinic of Pulmonology, University Hospital and University of Zurich, Zurich, Switzerland.
Ghio SDivisione di Cardiologia, Fondazione IRCCS Policlinico S Matteo, Pavia, Italy.
Gumbiene LCompetence Centre of Pulmonary Hypertension, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania.
Palevičiūtė ECompetence Centre of Pulmonary Hypertension, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania.
Jurevičienė ECompetence Centre of Pulmonary Hypertension, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania.
Cittadini ADepartment of Translational Medical Sciences, "Federico II" University, Naples, Italy.
Stanziola AADepartment of Clinical Medicine and Surgery, "Federico II" University, Naples, Italy.
Marra AMCentre 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.
Kovacs GDivision of Pulmonology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
Olschewski HDivision of Pulmonology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
Barberà JADepartment of Pulmonary Medicine, Hospital Clinic-IDIBAPS, University of Barcelona, Barcelona and Biomedical Research Networking Center on Respiratory Diseases (CIBERES), Spain.
Blanco IDepartment of Pulmonary Medicine, Hospital Clinic-IDIBAPS, University of Barcelona, Barcelona and Biomedical Research Networking Center on Respiratory Diseases (CIBERES), Spain.
Spruit MAResearch and Development, Ciro, Horn, Netherlands.
Franssen FMEDepartment of Research and Education, CIRO, Horn, The Netherlands.
Vonk Noordegraaf ADepartment of Pulmonology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, VU University Medical Center, Amsterdam, The Netherlands.
Reis ADepartment of Internal Medicine, Hospital Geral de Santo António, Porto, Portugal.
Santos MDepartment of Internal Medicine, Hospital Geral de Santo António, Porto, Portugal.
Viamonte SGCentro de Rehabilitação do Norte, Porto/Centro Hospitalar Vila Nova de Gaia Espinho, Portugal.
Demeyer HDepartment of Pneumology, University Hospital Leuven, Leuven, Belgium.
Delcroix MDepartment of Pneumology, University Hospital Leuven, Leuven, Belgium.
Bossone EDepartment of Cardiology, Antonio Carderelli Hospital, Naples, Italy.
Johnson MScottish Pulmonary Vascular Unit, Golden Jubilee National Hospital, Glasgow, UK.
English
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; χ2 P = 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.