A STEP for Patients Prior to Undergoing TAVR: A Pilot Study

OSF Healthcare System

Status: Terminated

Conditions: Aortic Valve Stenosis; Frail Elderly

Treatments: Behavioral: Supervised TAVR Exercise Program

Study type: Interventional

Funder types: Other

Identifiers

NCT02766075

837484

Details and patient eligibility

About

The aim of this pilot study is to establish whether a Supervised TAVR Exercise Program (STEP) can safely improve the frailty status in patients with symptomatic severe aortic valve stenosis prior to undergoing transcatheter aortic valve replacement (TAVR).

Full description

TAVR is an approved alternative therapy for patients with severe aortic valve stenosis who are deemed inoperable or high-risk for surgical aortic valve replacement (SAVR). Despite a very high procedural success rate (>95%), mortality rates after TAVR at 1- and 2-year follow-up remain ≥25% and ≥34%, respectively. It is becoming increasingly evident that frailty, as a clinical syndrome, has a large impact on this long term mortality. In a study by Green, et al. frailty status was independently associated with increased 1-year mortality (OR=3.5) after TAVR. The investigators' own retrospective analysis showed that impaired mobility and malnutrition were significantly associated with a longer hospital length of stay (5 days vs. 3 days), and increased total cost (on average, an additional $10,000 per patient). Given the phenotype of frailty is characterized by reductions in muscle mass, strength, endurance and activity level, a STEP is ideally suited to counteract these impairments. This pilot study aims to establish whether a STEP can safely improve the frailty score in patients with symptomatic severe aortic valve stenosis prior to undergoing TAVR.

This single-center pilot study will be conducted in partnership between Heart Care Midwest (HCMW), OSF St. Francis Medical Center (OSF SFMC), and University of Illinois College of Medicine at Peoria (UICOMP). UICOMP Center of Outcomes Research will provide analytical support. The study will be funded by an operational research grant from OSF SFMC.

Enrollment: 4 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All adult patients scheduled to undergo first-time elective TAVR

Exclusion criteria

• Vulnerable populations including prisoners, pregnant females and patients less than 18 years age.
• Patients with history of unstable angina, myocardial infarction, or decompensated heart failure in the week prior to screening
• Patients with physical limitations (i.e. debilitating stroke, amputation, unable to complete initial screening frailty profile)
• Patients with advanced dementia or cognitive deficits (i.e. unable to follow instructions of initial screening frailty profile)
• Exercise-induced arrhythmias

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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4 participants in 2 patient groups

Supervised TAVR Exercise Program (STEP)

Experimental group

Description:

Subjects in the experimental arm will participate in an individualized 4-week STEP prior to undergoing TAVR. All subjects will undergo serial frailty assessments by a blinded research assistant at baseline, pre-TAVR, and 30-days post-TAVR.

Treatment:

Behavioral: Supervised TAVR Exercise Program

Standard of Care

No Intervention group

Description:

Subjects in the no intervention arm will proceed with their TAVR after a minimum 4 weeks without an exercise intervention. All subjects will undergo serial frailty assessments by a blinded research assistant at baseline, pre-TAVR, and 30-days post-TAVR.