NCT02766075

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

A Supervised TAVR Exercise Program (STEP) for Patients Prior to Undergoing Transcatheter Aortic Valve Replacement (TAVR): A Pilot Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: OSF Healthcare System · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2016-05-09
• Last updated: 2018-04-12

Locations

1 site across 1 country: United States