caa a22 4500 606158332 CHVBK 20210128100618.0 cr unu---uuuuu 210128e20151201xx s 000 0 eng 10.1007/s10557-015-6623-4 doi (NATIONALLICENCE)springer-10.1007/s10557-015-6623-4 Rationale and Design of a Randomized Controlled Trial Evaluating Whole Muscle Exercise Training Effects in Outpatients with Pulmonary Arterial Hypertension (WHOLEi+12) [Elektronische Daten] [Fabian Sanchis-Gomar, Laura González-Saiz, Paz Sanz-Ayan, Carmen Fiuza-Luces, Carlos Quezada-Loaiza, Angela Flox-Camacho, Alfredo Santalla, Diego Munguía-Izquierdo, Alejandro Santos-Lozano, Helios Pareja-Galeano, Ignacio Ara, Pilar Escribano-Subías, Alejandro Lucia] Background and Aims: Physical exercise is an important component in the management of pulmonary artery hypertension (PAH). The aim of this randomized controlled trial (RCT) is to determine the effects of an 8-week intervention combining muscle resistance, aerobic and inspiratory pressure load exercises in PAH outpatients. Methods: The RCT will be conducted from September 2015 to September 2016 following the recommendations of the Consolidated Standards of Reported Trials (CONSORT), with a total sample size of n ≥ 48 (≥24 participants/group). We will determine the effects of the intervention on: (i) skeletal-muscle power and mass (primary end points); and (ii) NT-proBNP, cardiopulmonary exercise testing variables (VO2peak, ventilatory equivalent for CO2 at the anaerobic threshold (VE/VCO2 at the AT), end-tidal pressure of CO2 at the anaerobic threshold (PETCO2 at the AT), 6-min walking distance (6MWD), maximal inspiratory pressure (PImax), health-related quality of life (HRQoL), objectively-assessed spontaneous levels of physical activity, and safety (secondary end points). Conclusions and Perspectives: This trial will provide insight into biological mechanisms of the disease and indicate the potential benefits of exercise in PAH outpatients, particularly on muscle power. Springer Science+Business Media New York, 2015 Resistance exercise nationallicence Pulmonary disease nationallicence VO2peak nationallicence NT-proBNP nationallicence Cardio-pulmonary exercise testing nationallicence Sanchis-Gomar Fabian Research Institute Hospital 12 de Octubre (‘i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain aut González-Saiz Laura Research Institute Hospital 12 de Octubre (‘i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain aut Sanz-Ayan Paz Department of Rehabilitation, Hospital Universitario 12 de Octubre, Avda. de Córdoba s/n, 28041 Madrid, Spain aut Fiuza-Luces Carmen Research Institute Hospital 12 de Octubre (‘i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain aut Quezada-Loaiza Carlos Cardiology Department, Hospital Universitario 12 de Octubre, Avda. de Córdoba s/n, 28041 Madrid, Spain aut Flox-Camacho Angela Cardiology Department, Hospital Universitario 12 de Octubre, Avda. de Córdoba s/n, 28041 Madrid, Spain aut Santalla Alfredo Research Institute Hospital 12 de Octubre (‘i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain aut Munguía-Izquierdo Diego Department of Sports and Computer Science, Section of Physical Education and Sports, Universidad Pablo de Olavide, ES-41013 Seville, Spain aut Santos-Lozano Alejandro Research Institute Hospital 12 de Octubre (‘i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain aut Pareja-Galeano Helios Research Institute Hospital 12 de Octubre (‘i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain aut Ara Ignacio Growth, Exercise, Nutrition and Development (GENUD) Toledo Research Group, Universidad de Castilla-La Mancha, Avda Carlos III s/n, 45071 Toledo, Spain aut Escribano-Subías Pilar Cardiology Department, Hospital Universitario 12 de Octubre, Avda. de Córdoba s/n, 28041 Madrid, Spain aut Lucia Alejandro Research Institute Hospital 12 de Octubre (‘i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain aut Cardiovascular Drugs and Therapy Springer US; http://www.springer-ny.com 29/6(2015-12-01), 543-550 0920-3206 29:6<543 2015 29 10557 https://doi.org/10.1007/s10557-015-6623-4 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10557-015-6623-4 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Sanchis-Gomar Fabian Research Institute Hospital 12 de Octubre (‘i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain aut NATIONALLICENCE 700 1- González-Saiz Laura Research Institute Hospital 12 de Octubre (‘i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain aut NATIONALLICENCE 700 1- Sanz-Ayan Paz Department of Rehabilitation, Hospital Universitario 12 de Octubre, Avda. de Córdoba s/n, 28041 Madrid, Spain aut NATIONALLICENCE 700 1- Fiuza-Luces Carmen Research Institute Hospital 12 de Octubre (‘i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain aut NATIONALLICENCE 700 1- Quezada-Loaiza Carlos Cardiology Department, Hospital Universitario 12 de Octubre, Avda. de Córdoba s/n, 28041 Madrid, Spain aut NATIONALLICENCE 700 1- Flox-Camacho Angela Cardiology Department, Hospital Universitario 12 de Octubre, Avda. de Córdoba s/n, 28041 Madrid, Spain aut NATIONALLICENCE 700 1- Santalla Alfredo Research Institute Hospital 12 de Octubre (‘i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain aut NATIONALLICENCE 700 1- Munguía-Izquierdo Diego Department of Sports and Computer Science, Section of Physical Education and Sports, Universidad Pablo de Olavide, ES-41013 Seville, Spain aut NATIONALLICENCE 700 1- Santos-Lozano Alejandro Research Institute Hospital 12 de Octubre (‘i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain aut NATIONALLICENCE 700 1- Pareja-Galeano Helios Research Institute Hospital 12 de Octubre (‘i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain aut NATIONALLICENCE 700 1- Ara Ignacio Growth, Exercise, Nutrition and Development (GENUD) Toledo Research Group, Universidad de Castilla-La Mancha, Avda Carlos III s/n, 45071 Toledo, Spain aut NATIONALLICENCE 700 1- Escribano-Subías Pilar Cardiology Department, Hospital Universitario 12 de Octubre, Avda. de Córdoba s/n, 28041 Madrid, Spain aut NATIONALLICENCE 700 1- Lucia Alejandro Research Institute Hospital 12 de Octubre (‘i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain aut NATIONALLICENCE 773 0- Cardiovascular Drugs and Therapy Springer US; http://www.springer-ny.com 29/6(2015-12-01), 543-550 0920-3206 29:6<543 2015 29 10557