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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02597985

Acronym

TAVR-FRAILTY

Enrollment

Registered

2015-11-05

Start date

2015-10-31

Completion date

2019-09-10

Last updated

2021-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Stenosis

Keywords

Frailty

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.

Interventions

OTHERPrehabilitation

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.

OTHERUsual Care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in Score on short physical performance battery (SPPB) test	Baseline, approximately 1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026