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

Not Applicable

Terminated

• Conditions: Frail Elderly; Aortic Valve Stenosis
• Interventions: Behavioral: Supervised TAVR Exercise Program

• Registration Number: NCT02766075
• Lead Sponsor: OSF Healthcare System

Brief Summary

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).

Detailed 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.

Study Timeline

• Study First Submitted: 2016-04-28
• Study Start: 2016-05
• Study First Submitted QC: 2016-05-05
• Study First Posted: 2016-05-09
• Status Verified: 2017-04
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised TAVR Exercise Program (STEP)	Supervised TAVR Exercise Program	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.

Primary Outcome Measures

Name	Time	Method
Change in Frailty Score from Baseline to post-STEP	Baseline, 6-weeks

Secondary Outcome Measures

Name	Time	Method
Adverse Events	6-weeks
Change in Gait Speed (5-Meter Walk Test) from Baseline to post-STEP	Baseline, 6-weeks
Change in Gait Speed (5-Meter Walk Test) from Baseline to 30-days post-TAVR	Baseline, 30-days post-TAVR
Change in Grip Strength (Dynamometer) from Baseline to 30-days post-TAVR	Baseline, 30-days post-TAVR
Change in Independent Activity (Katz Activities of Daily Living Survey) from Baseline to to 30-days post-TAVR	Baseline, 30-days post-TAVR
Change in Frailty Score from Baseline to 30-days post-TAVR	Baseline, 30-days post-TAVR
Change in Grip Strength (Dynamometer) from Baseline to post-STEP	Baseline, 6-weeks
Change in Independent Activity (Katz Activities of Daily Living Survey) from Baseline to post-STEP	Baseline, 6-weeks
Change in Malnutrition (Serum Albumin Level) from Baseline to 30-days post-TAVR	Baseline, 30-days post-TAVR

Trial Locations

Locations (1)

OSF St. Francis Medical Center; 🇺🇸 Peoria, Illinois, United States