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

Aortic Valve Stenosis Clinical Trial

— STEP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02766075
• Other study ID #: 837484
• Status: Terminated
• Phase: N/A
• First received: April 28, 2016
• Last updated: April 10, 2018
• Start date: May 2016
• Est. completion date: February 2018

Study information

• Verified date: April 2017
• Source: OSF Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Frail Elderly

Intervention

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.

Locations

Country	Name	City	State
United States	OSF St. Francis Medical Center	Peoria	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
OSF Healthcare System	HeartCare Midwest, OSF St. Francis Medical Center, University of Illinois College of Medicine at Peoria

Country where clinical trial is conducted

United States, 

Outcome

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