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

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.

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Key information

Conditions

Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiovascular Diseases Frailty Heart Diseases Heart Valve Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Ventricular Outflow Obstruction

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prehabilitation

Other

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.

Usual Care

Other

Primary outcomes

Change in Score on short physical performance battery (SPPB) test

Time frame: Baseline, approximately 1 year

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Acronym: TAVR-FRAILTY

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2019
First posted: Nov 5, 2015
Registry last updated: Dec 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed