Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement

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A Retrospective Registry Study ROUTE Registry Of the Utilisation of the Transaortic (Tao) TAVI Approach Using the Edwards Sapien XT Valve The Medtronic CoreValve™ Evolut R™ CE Mark Clinical Study Microembolic Signals and Cerebrospinal Fluid Markers of Neuronal Damage After Surgical Aortic Valve Replacement Direct Aortic vs Subclavian Access for TAVI: a Review of the Outcomes in the UK Self-Centering Guide Catheter Feasibility Study Dedicated Sheath Feasibility Study Feasibility And Safety of Early Discharge After Transfemoral Transcatheter Aortic Valve Implantation Left Atrial Appendage CLOSURE for the Prevention of Thromboembolisms in Patients Undergoing Aortic Bioprosthesis Surgery Low-dose-contrast Cardiac Computed Tomography CoreValve Evolut Pro Registry 18-F Sodium Fluoride (18F-NaF) PET for the Assessment of Bioprosthetic Aortic Valve Durability and Outcomes Conscious Sedation vs General Anesthesia in TAVR Patients Association of Type of Anesthetic and Outcomes in Transfemoral Aortic Valve Replacement Temporary Pacemaker in Transcatheter Aortic Valve Implantation Patients Inflammatory Response in Aortic Valve Replacement CoreValve Advance-II Study: Prospective International Post-market Study Impact of Home-based Cardiac Rehabilitation on Outcomes After TAVR Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement EDWARDS INTUITY Elite Valve System Clinical and Geriatric Assessment in Elderly Patients Before and After TAVI or MitraClip Positioning Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve (THV) in the Chinese Population Safety and Effectiveness of Edwards Lifesciences SAPIEN XT THV in the Chinese Population Physical Activity in Patients After Aortic Valve Replacement (Valve-ex) Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial Rotterdam EDOXaban Leaflet Evaluation in Patients After Transcatheter Aortic Valve Implantation The preDIlatation in tRanscathEter aortiC Valve implanTation Trial Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe) Non-invasive Blood Pressure and Cardiac Output Measurement by Using Applanation Tonometry Surgical Trauma After Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement Platelet Reactivity After TAVI: A Multicenter Pilot Study Placement of Aortic Balloon Expandable Transcatheter Valves Trial (TransApical) Direct Left Ventricular Rapid Pacing Via the Valve Delivery Guide-wire in TAVI Assessments of Thrombus Formation in TAVI Aortic Valve and Root Measurements Under Real-Time 3-Dimensional Visualization During Angiography TAVI Protocol – Paravertebral Block Study Evaluate the Transcatheter Artificial Aortic Valve and Transcatheter Artificial Heart Values Delivery System ADVANCE Direct Aortic Study German Aortic Valve Registry Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement Transfemoral Transcatheter Aortic Valve Implantation With or Without Predilation of the Aortic Valve (EASE-IT TF) Sizing of the PERCEVAL® Sutureless Aortic Valve Prosthesis Using the CT: a Feasibility Study A STEP for Patients Prior to Undergoing TAVR: A Pilot Study Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve Left Ventricular Reverse Remodeling In Aortic Valve Replacement With Single Strip Pericardium Versus Mechanical Valve Engager Align Post-market Clinical Study Improved HRV, Inflammation Markers and Endothelial Function After TAVI Diagnostic Three Dimensional Echocardiography Study Protocol DEFLECT III: A Prospective, Randomized Evaluation of the TriGuard™ HDH Embolic Deflection Device During TAVI Subclinical Aortic Valve Bioprosthesis Thrombosis Assessed With 4D CT The Asian Pacific TAVR Multicenter Registry Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis Multi Modal Cardiac Imaging Prior Transcatheter Aortic Valve Implantation Surgical Treatment of Aortic Stenosis With a Next Generation, Rapid Deployment Surgical Aortic Valve Added Value of Patient-specific Computer Simulation in Transcatheter Aortic Valve Implantation (TAVI) Transcatheter Aortic Valve Replacement System Pivotal Trial Cerebrovascular EveNts in Patients Undergoing TranscathetER Aortic Valve Implantation With Balloon-expandable Valves Versus Self-expandable Valves. Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement Microembolic Signals and Serum Markers of Neuronal Damage During Transcatheter Aortic Valve Implantation. CHANGE Neo™ TA Registry With ACURATE Neo™ Aortic Bioprosthesis and ACURATE Neo™ TA Transapical Delivery System FORWARD PRO Study Interventional Post-market Study With the Evolut™ PRO System SMT Embolic Deflection CE Mark Trial DEFLECT I Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight Nitinol Circular Blade Functional Assessment In TAVI: FAITAVI CoreValve VIVA Study Evaluation of the Clinical Outcomes of CoreValve in Degenerative Surgical Aortic Bioprosthesis. POLESTAR Trial – An International Multi-center Early Discharge TAVI Program REPRISE EDGE 29 mm EU Study The CONFIDENCE Registry Interest of Cardiac Computed Tomography to Optimize and Improve the Procedure of TAVI Transapical Implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System – The Engager European Pivotal Trial Post-Market Follow-up of the CENTERA Transcatheter Heart Valve System SecOnd-generation seLf-expandable Versus Balloon-expandable Valves and gEneral Versus Local Anesthesia in TAVI Balloon Aortic Valvuloplasty During Surgical Aortic Valve Replacement The PROTEMBO SF Trial Adjuvant Radiation in Aortic Valvuloplasty – ARAVA Value of Oral Phytate (InsP6) in the Prevention of Progression of the Cardiovascular Calcifications Supra-Annular vs. Annular ValvEs for Small Annuli Heart Leaflet Technologies Valve Study A Study to Evaluate the Neuro-embolic Consequences of TAVR Femoral vs Radial Approach and MRI Evaluation of Strokes Mortality Post-TAVI and Correlation With Haemodynamic Parameters. Pilot Study of Cognitive and Functional Outcomes Following TAVI Neuropsychological Testing in Patients Undergoing Transvascular Aortic Valve Implantation Costs, Cognitive Abilities and Quality of Life After Transcatheter Aortic Valve Implantation and Surgical Aortic Valve Replacement SOURCE XT REGISTRY Imaging Histone Deacetylase in the Heart A pragmatiC sTrategy to Promote actIVity and Enhance Quality of Life AFTER Transcatheter Aortic Valve Replacement The PARTNER II Trial: S3iCAP Symetis ACURATE Neo™ Valve Implantation SAVI TF Registry X-ray Fluoroscopy Fused With Computed Tomography (XFC) Technical Development First in Man Study of the JenaValve TAVI Plus System Transfemoral Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients Undergoing TAVR Ascending Aortic Dilation in BiAV After TAVR Safety and Performance Study of the Optimum Transcatheter Aortic Valve Transcatheter Aortic Valve Replacement With Extracorporeal Life System Support The TransCatheter Valve and Vessels Trial TAVR Without Predilatation Safety and Efficacy Study of MicroPort’s Transcatheter Aortic Valve and Delivery System for TAVI Enable® Aortic Sutureless Bioprosthesis Evaluation Radiation Following Percutaneous Balloon Aortic Valvuloplasty to Prevent Restenosis Myocardial Flow Reserve in Severe AS Without Obstructive Coronary Artery Disease Clinical Significance of Collagen Metabolism Changes in Left Cardiac Ventricle Medtronic CoreValve Evolut R U.S. Clinical Study (Evolut 34R Addendum) HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON CANADA Aortic Stenosis Pre-Transcatheter Aortic Valve Replacement (TAVR) Procedure CT Scan PREVAIL-20J – Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial RESPOND EDGE Post Market Study Impact of SAVR and TAVR on Patient’s Activity and Mobility BIOVALVE – I / II Clincial Investigation Comparison of Blood and Crystalloid Cardioplegia Ventriculo-arterial Coupling Modification Evaluated by PRAM During TAVI Procedure CoreValve Advance International Post Market Study HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON SWISS TAVI Registry CoreValve™ Evolut R™ FORWARD Study Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Early Feasibility Trial Follow-up After TAVR Without Systematic Intensive Care Unit Admission ACURATE NEO/TF Transcatheter Heart Valves and Non-inferiority Versus Medtronic CoreValve Systems CoreValve™ Evolut R™ 34 mm System Registry (CoreValve34) Inflammation and Thrombosis in Patients With Severe Aortic Stenosis After Transcatheter Aortic Valve Replacement (TAVR) ACURATE TA™ Valve Implantation Registry: SAVI 2 Colibri Transcatheter Aortic Heart Valve System Study HLT Meridian Valve CE Mark Trial Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Feasibility Trial CANADA Assessment of Arrhythmias in Patients Undergoing Transcatheter Aortic Valve Implantation Using a Small 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Effect of vItamin K2 on Calciummetabolism on 18F-NaF PET/MRI Endothelial Progenitors in Aortic Stenosis: Association With Aortic Stenosis Progression and Severity Outcomes of Transcatheter Aortic Valve Implantation in Oncology Patients With Severe Aortic Stenosis Evaluation of BAV in Different Hemodynamic Entities of Severe AS Intravenous Iron Supplement for Iron Deficiency in Patients With Severe Aortic Stenosis The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic Severe Aortic Stenosis Clinical Value of Stress Echocardiography in Moderate Aortic Stenosis CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis Requiring Aortic Valve Replacement Outcomes of Transcatheter Aortic Valve Implantation in Management of Severe Symptomatic Aortic Stenosis Safety and Efficacy of Lotus Valve For TAVI In Patients With Severe Aortic Stenosis In Chinese Population Rehabilitation in Aortic Stenosis Patients Aortic Stenosis Evaluated Via Modern Ballistocardiography and Seismocardiography Study of Platelet Activation by Severe Aortic Stenosis and Its Correction by Transcatheter Aortic Valve Implantation Sizing-sTrategy of Bicuspid AoRtic Valve Stenosis With Transcatheter Self-expandable Valve The Plasma Serotonin and Aortic Stenosis: a Pilot Study. 18F-NaF Uptake and Aortic Stenosis Progression Cardiovascular Rehabilitation in Patients With Severe Aortic Stenosis Submitted to Valvar Correction Aortic Stenosis and PhosphodiEsterase Type 5 iNhibition (ASPEN): A Pilot Study Clinical Outcome of Patients With Low-gradient Severe Aortic Stenosis Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome The PARTNER 3 – Trial – The Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis Ventricular Remodeling In Patients With Aortic Stenosis Assessed 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Brief Title

Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement

Official Title

Home-Based Exercise Program For Recovery After Transcatheter Aortic Valve Replacement: A Pilot Study

Brief Summary

      Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure for older
      adults with severe symptomatic aortic stenosis who are considered high risk for surgical
      aortic valve replacement. Despite symptomatic and survival benefits, many patients experience
      functional decline after TAVR. This pilot study aims to test the feasibility of a home-based
      exercise intervention targeting endurance, strength, and balance as well as cognitive
      behavioral intervention to improve physical functioning and disability after TAVR.

Detailed Description

      We hypothesize that a home-based exercise program with cognitive behavioral intervention is
      more effective than home-based exercise alone; home-based exercise program with and without
      cognitive behavioral intervention is more effective than attention control educational
      intervention in preventing decline in physical function and disability after TAVR.

Study Type

Interventional

Primary Outcome

Change in the Late-Life Function and Disability Instrument (LLFDI) Score

Secondary Outcome

 Change in the Short Physical Performance Battery (SPPB) Summary Score

Condition

Aortic Valve Stenosis

Intervention

Exercise

Study Arms / Comparison Groups

 Exercise & Cognitive Behavioral Int.
Description:  A physical therapist will make home visits, beginning within 1 week of discharge, to deliver an individualized exercise program and cognitive behavioral interventions.

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

61

Start Date

August 1, 2017

Completion Date

May 6, 2020

Primary Completion Date

May 6, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥ 65 years

          -  Underwent transcatheter aortic valve replacement

          -  Lives within 20-mile radius of the recruiting site

          -  Plan to be discharged home

          -  Able to provide informed consent

        Exclusion Criteria:

          -  Stroke or any other medical disease that precludes participation in the exercise
             program

          -  Severe cognitive impairment (Mini-Mental State Examination < 15)

          -  Current enrollment in another clinical trial

Gender

All

Ages

65 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Dae Hyun Kim, MD, MPH, ScD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02805309

Organization ID

2017P000106

Secondary IDs

P30AG031679

Responsible Party

Principal Investigator

Study Sponsor

Brigham and Women's Hospital

Collaborators

 Hebrew SeniorLife

Study Sponsor

Dae Hyun Kim, MD, MPH, ScD, Principal Investigator, Beth Israel Deaconess Medical Center

Verification Date

July 2020