Fabian Sanchis-Gomar1, Laura González-Saiz2, Paz Sanz-Ayan3, Carmen Fiuza-Luces2, Carlos A Quezada-Loaiza4, Angela Flox-Camacho4, Alfredo Santalla2,5, Diego Munguía-Izquierdo5, Alejandro Santos-Lozano2,6, Helios Pareja-Galeano2,7, Ignacio Ara8, Pilar Escribano-Subías4, Alejandro Lucia2,7. 1. 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. 2. Research Institute Hospital 12 de Octubre ('i + 12'), Edificio actividades ambulatorias, 6ª planta. Avda. de Córdoba s/n, 28041, Madrid, Spain. 3. Department of Rehabilitation, Hospital Universitario 12 de Octubre, Avda. de Córdoba s/n, 28041 Madrid, Spain. 4. Cardiology Department, Hospital Universitario 12 de Octubre, Avda. de Córdoba s/n, 28041 Madrid, Spain. 5. Department of Sports and Computer Science, Section of Physical Education and Sports, Universidad Pablo de Olavide, ES-41013 Seville, Spain. 6. Department of Health Sciences, European University Miguel de Cervantes, C/Padre Julio Chevalier, 47012, Valladolid, Spain. 7. European University, C/Tajo S/N, Urbanización El Bosque, 28670 Villaviciosa de Odón, Madrid, Spain. 8. Growth, Exercise, Nutrition and Development (GENUD) Toledo Research Group, Universidad de Castilla-La Mancha, Avda Carlos III s/n, 45071 Toledo, Spain.
Abstract
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.
RCT Entities:
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.
Authors: Alejandro Santos-Lozano; Paz Sanz-Ayan; Laura González-Saiz; Carlos A Quezada-Loaiza; Carmen Fiuza-Luces; Angela Flox-Camacho; Diego Munguía-Izquierdo; Alfredo Santalla; María Morán; Pilar Escribano-Subías; Alejandro Lucia Journal: Data Brief Date: 2017-03-18
Authors: Laura González-Saiz; Alejandro Santos-Lozano; Carmen Fiuza-Luces; Paz Sanz-Ayán; Carlos A Quezada-Loaiza; Ana Ruiz-Casado; Lidia B Alejo; Angela Flox-Camacho; María Morán; Alejandro Lucia; Pilar Escribano-Subías Journal: Ann Transl Med Date: 2018-06