title: Rationale and Design of a Randomized Controlled Trial Evaluating Whole Muscle Exercise Training Effects in Outpatients with Pulmonary Arterial Hypertension (WHOLEi+12).
abstract: OBJECTIVE
  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 CO2at the anaerobic threshold (VE/VCO2at the AT), end-tidal pressure of CO2at the anaerobic threshold (PETCO2at 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
  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.
authors.affiliation: Research Institute Hospital 12 de Octubre ('i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain. fabian.sanchis@uv.es.
authors.forename: Fabian
authors.initials: F
authors.lastname: Sanchis-Gomar
authors.affiliation: Research Institute Hospital 12 de Octubre ('i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain.
authors.forename: Laura
authors.initials: L
authors.lastname: González-Saiz
authors.affiliation: Department of Rehabilitation, Hospital Universitario 12 de Octubre, Avda. de Córdoba s/n, 28041 Madrid, Spain.
authors.forename: Paz
authors.initials: P
authors.lastname: Sanz-Ayan
authors.affiliation: Research Institute Hospital 12 de Octubre ('i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Fiuza-Luces
authors.affiliation: Cardiology Department, Hospital Universitario 12 de Octubre, Avda. de Córdoba s/n, 28041 Madrid, Spain.
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Quezada-Loaiza
authors.affiliation: Cardiology Department, Hospital Universitario 12 de Octubre, Avda. de Córdoba s/n, 28041 Madrid, Spain.
authors.forename: Angela
authors.initials: A
authors.lastname: Flox-Camacho
authors.affiliation: Research Institute Hospital 12 de Octubre ('i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain.|Department of Sports and Computer Science, Section of Physical Education and Sports, Universidad Pablo de Olavide, ES-41013 Seville, Spain.
authors.forename: Alfredo
authors.initials: A
authors.lastname: Santalla
authors.affiliation: Department of Sports and Computer Science, Section of Physical Education and Sports, Universidad Pablo de Olavide, ES-41013 Seville, Spain.
authors.forename: Diego
authors.initials: D
authors.lastname: Munguía-Izquierdo
authors.affiliation: Research Institute Hospital 12 de Octubre ('i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain.|Department of Health Sciences, European University Miguel de Cervantes, C/Padre Julio Chevalier, 47012, Valladolid, Spain.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Santos-Lozano
authors.affiliation: Research Institute Hospital 12 de Octubre ('i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain.|European University, C/Tajo S/N, Urbanización El Bosque, 28670 Villaviciosa de Odón, Madrid, Spain.
authors.forename: Helios
authors.initials: H
authors.lastname: Pareja-Galeano
authors.affiliation: Growth, Exercise, Nutrition and Development (GENUD) Toledo Research Group, Universidad de Castilla-La Mancha, Avda Carlos III s/n, 45071 Toledo, Spain.
authors.forename: Ignacio
authors.initials: I
authors.lastname: Ara
authors.affiliation: Cardiology Department, Hospital Universitario 12 de Octubre, Avda. de Córdoba s/n, 28041 Madrid, Spain.
authors.forename: Pilar
authors.initials: P
authors.lastname: Escribano-Subías
authors.affiliation: Research Institute Hospital 12 de Octubre ('i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain.|European University, C/Tajo S/N, Urbanización El Bosque, 28670 Villaviciosa de Odón, Madrid, Spain.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Lucia
keywords: Cardio-pulmonary exercise testing; NT-proBNP; Pulmonary disease; Resistance exercise; VO2peak