Aortic Valve Stenosis Clinical Trial
Official title:
Cardiovascular RehAbilitation in Patients With Severe AoRtic StEnosis Submitted to Valvar Correction: Effects on Muscle Architecture, Tissue Oxygenation, EndoThelial Function, Inflammatory Profile, and AutoNomic Control - Randomized Trial
This study will be evaluate the autonomic, endothelial and hemodynamic functions, inspiratory muscle strength, peripheral tissue oxygenation, peripheral and respiratory muscle architecture, and inflammatory profile of severe AS patients submitted undergoing to valve replacement (sAVR) or transcatheter aortic valve implantation (TAVI), and their influence on the pathophysiological mechanisms involved in cardiovascular rehabilitation.
Background: Aortic stenosis (AS) is a disease characterized by the inadequate valve opening,
compromising the cardiac output. Surgical aortic valve replacement (sAVR) is the procedure
indicates for valve repair in AS symptomatic cases whereas the transcatheter aortic valve
implantation (TAVI) is the procedure indicates for sAVR contraindicated cases.
Objective: To evaluate the effect of the cardiac rehabilitation program (pre-procedure, early
post-procedure, and late post-procedure) in autonomic, endothelial and hemodynamic functions,
inspiratory muscle strength, peripheral tissue oxygenation, peripheral and respiratory muscle
architecture, and inflammatory profile of severe AS patients submitted to a valve repair
procedure (sAVR or TAVI).
Methods: The present study will be a randomized double-blind clinical trial in patients
indicated to valve repair procedure. This research will be divided into four phases: phase 1
(pre-procedure); phase 2 (early post-procedure); phase 3 (late post-procedure) and phase 4
(follow-up). Phase 1: participants will be randomized in PR-I (pre-intervention) or PR-C
(control). Pre-procedure rehabilitation program will consist of daily neuromuscular
electrical stimulation (NMES) in knee extensor muscles and inspiratory muscle training (IMT)
sessions. PR-C group will receive daily visits, but with a NMES + IMT protocols using a
minimal load. Phase 2: a new random will be done between ER-II or ER-CI (intervention) and
ER-IC or ER-CC (control). Intervention groups will undertake an early post-procedure
rehabilitation (NMES in knee extensor muscle plus IMT for six weeks). Control groups will
receive the same protocol using a minimal load without load progression. Phase 3: all
patients will be referred to the conventional cardiac rehabilitation program (aerobic and
resistance training) for 8-weeks. Phase 4: follow-up (no interventions), will be done after
3, 6, 9 and 12 months. Assessment protocol will be composed by cardiopulmonary exercise test,
autonomic (heart rate variability), endothelial (flow-mediated vasodilation), hemodynamic
function (cardiothoracic impedance) functional capacity (six-minute walk test), maximum
inspiratory pressure, peripheral and respiratory muscle architecture (ultrasonography), and
tissue oxygenation (near-infrared spectroscopy), and inflammatory profile (OxLDL, TGF-β,
TNF-α, IL-1b, IL-10 and ICAM-1) Appropriate statistic tests will be used to compare the
time-rehabilitation (experimental vs sham) and group-interaction (sAVR vs TAVI). If samples
are abandoned or lost, basal data will be double entered to characterize the
intention-to-treat analysis.
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