Prehabilitation to Improve Functional and Clinical Outcomes in Patients With Aortic Stenosis

Study Overview
=================
Brief Summary
-----------------
Transcatheter aortic valve replacement (TAVR) is a treatment alternative among high-risk elderly with aortic stenosis, however, mortality remains high. Fifty percent of patients undergoing TAVR exhibit frailty, a syndrome associated with poor survival. It is unknown whether interventions to improve frailty before TAVR (prehabilitation) will improve outcomes after TAVR. This study plans to evaluate whether simple cardiac exercise interventions to improve physical performance before TAVR improves outcomes after TAVR.

Official Title
-----------------
Prehabilitation to Improve Functional and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Replacement: TAVR-FRAILTY Trial

Conditions
-----------------
Aortic Stenosis

Intervention / Treatment
-----------------
* Other: Prehabilitation
* Other: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Eligibility for TAVR SPPB<9 Able to exercise Able to come for follow-up visits Able to give informed consent Exclusion criteria: New York Heart Association (NYHA) Class III/IV congestive heart failure (CHF) Presyncope or syncope as presentation Acute coronary syndrome Unable to exercise Dementia Sustained ventricular arrhythmia Stroke with neurological deficit Advanced Parkinson's Participated in an exercise program

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prehabilitation<br>Will receive 4 weeks of supervised exercised prescription before they undergo TAVR and will monitor and record, improvement if any, in the short-term physical performance battery score | Other: Prehabilitation<br>* Supervised exercise training intervention will include three sessions per week for four weeks at a Mayo Clinic system cardiac rehabilitation facility. The Rochester, Minnesota Cardiac Rehabilitation Program will provide guidance and oversight. Modes of aerobic exercise will include treadmill walking (the primary mode of training) supplemented with non-weight-bearing activities such as stationary cycling and combination arm/leg recumbent exercise (NuStep device), as needed. Intensity will be set using Borg Perceived Exertion Scale (RPE) ratings of 12-14 (somewhat hard), keeping patients below the threshold for more than mild angina.<br>|
| Placebo Comparator: Usual care<br>Will receive usual care | Other: Usual Care<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Score on short physical performance battery (SPPB) test |  | Baseline, approximately 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Frailty