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

NCT ID: NCT02766075

Last Updated: 2018-04-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-02-28

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.

Conditions

Frail Elderly; Aortic Valve Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Supervised TAVR Exercise Program (STEP)

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.

Group Type: EXPERIMENTAL

Supervised TAVR Exercise Program

Intervention Type: BEHAVIORAL

Individualized exercise program designed and implemented by licensed physical therapy clinicians in three 60-minute sessions per week for four weeks. Upon randomization, subjects in the Intervention Group will undergo an initial Dynamic Gait \& Balance Assessment by a licensed physical therapy clinician. The physical therapy clinician will use this assessment to design and implement an individualized STEP in three 60-minute sessions per week for four weeks. Subjects will proceed with their pre-TAVR testing in conjunction with the STEP sessions.

Standard of Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Supervised TAVR Exercise Program

Individualized exercise program designed and implemented by licensed physical therapy clinicians in three 60-minute sessions per week for four weeks. Upon randomization, subjects in the Intervention Group will undergo an initial Dynamic Gait \& Balance Assessment by a licensed physical therapy clinician. The physical therapy clinician will use this assessment to design and implement an individualized STEP in three 60-minute sessions per week for four weeks. Subjects will proceed with their pre-TAVR testing in conjunction with the STEP sessions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HeartCare Midwest

UNKNOWN

Sponsor Role: collaborator

University of Illinois College of Medicine at Peoria

OTHER

Sponsor Role: collaborator

OSF Healthcare System

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jay N Patel, MD

Role: PRINCIPAL_INVESTIGATOR

OSF Healthcare System

Locations

OSF St. Francis Medical Center

Peoria, Illinois, United States

Countries

United States

Other Identifiers

837484

Identifier Type: -

Identifier Source: org_study_id