Rationale and Design of a Randomized Controlled Trial Evaluating Whole Muscle Exercise Training Effects in Outpatients with Pulmonary Arterial Hypertension

Sanchis-Gomar, Fabian;  González-Saiz, Laura; Sanz-Ayan, Paz; Fiuza-Luces, Carmen;
Quezada-Loaiza, Carlos; Flox-Camacho, Angela; Santalla, Alfredo;
Munguía-Izquierdo, Diego; Santos-Lozano, Alejandro; Pareja-Galeano,
Helios; Ara, Ignacio; Escribano-Subías, Pilar; Lucia, Alejandro.
Cardiovascular Drugs and Therapy, December 2015, Vol. 29 Issue: Number
6 p543-550, 8p;

Abstract: 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.
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).                   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.