Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction

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Effect of Steroids on Cerebral Inflammation and Neuronal Damage After Surgical Aortic Valve Replacement Remote Ischemic Preconditioning for Renal Protection in TAVI Avr Thrombosis OutcoMe Study PRospective Observation of Aortic reGuRgitation aftEr TAVI and progreSS Over Time: PROGRESS PVL Registry Virtual Reality Assisted Conscious Sedation During TAVI The Aortic Valve DECalcification (AVADEC) Trial Influence of EPICardial Adipose Tissue in HEART Diseases: EPICHEART Study Three Dimensional Imaging and Wireless Technologies to Enhance Medical Care in Space Personalized Activity Intervention in Rehabilitation After Cardiac Operations (the PACO Trial) Comparison of Two Biological Aortic Valves. Mosaic Ultra and Trifecta. 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Brief Title

Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction

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

Brief Summary

      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.

Detailed Description

      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.

Study Type

Interventional

Primary Outcome

Cardiorespiratory function

Secondary Outcome

 Autonomic function

Condition

Aortic Valve Stenosis

Intervention

cardiovascular rehabilitation program

Study Arms / Comparison Groups

 aortic valve replacement
Description:  patients with aortic stenosis submitted to aortic valve replacement procedure

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Behavioral

Estimated Enrollment

120

Start Date

August 2020

Completion Date

July 2022

Primary Completion Date

July 2021

Eligibility Criteria

        Inclusion Criteria: patients NYHA class II-IV who has not participated in a CRP three
        months before recruitment; older than 40 years; of both genders; with degenerative AS and
        indication for valve repair. The patients will not know which protocol to undergo.

        Exclusion Criteria: patients with low cognitive level to perform the assessment or
        intervention procedures; that exhibit unstable angina or any contraindications for the
        treatment or measurements; as well musculoskeletal, cerebrovascular, or psychiatric disease
        that prevents their participation in the research.

Gender

All

Ages

40 Years - 90 Years

Accepts Healthy Volunteers

No

Contacts

Marlus Karsten, PhD, 55 51 33038876, [email protected]

Location Countries

Brazil

Location Countries

Brazil

Administrative Informations

NCT ID

NCT02468219

Organization ID

IR00002509/FWA

Responsible Party

Principal Investigator

Study Sponsor

Irmandade Santa Casa de Misericórdia de Porto Alegre

Collaborators

 Federal University of Health Science of Porto Alegre

Study Sponsor

Marlus Karsten, PhD, Principal Investigator, Federal University of Health Science of Porto Alegre

Verification Date

May 2020