Clinical trial NCT02766075: A STEP for Patients Prior to Undergoing TAVR: A Pilot Study
Official title: A Supervised TAVR Exercise Program (STEP) for Patients Prior to Undergoing Transcatheter Aortic Valve Replacement (TAVR): A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Frail Elderly
Aortic Valve Stenosis
Keywords: Transcatheter Aortic Valve Disease
Supervised TAVR Exercise Program
Lead sponsor: OSF Healthcare System
Sponsor class: OTHER
Collaborators: name: HeartCare Midwest
name: University of Illinois College of Medicine at Peoria
First posted: 2016-05-09
Enrollment: 4
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Frailty Score from Baseline to post-STEP
timeFrame: Baseline, 6-weeks
Secondary outcomes:
measure: Adverse Events
timeFrame: 6-weeks
measure: Change in Frailty Score from Baseline to 30-days post-TAVR
timeFrame: Baseline, 30-days post-TAVR
measure: Change in Gait Speed (5-Meter Walk Test) from Baseline to post-STEP
timeFrame: Baseline, 6-weeks
measure: Change in Gait Speed (5-Meter Walk Test) from Baseline to 30-days post-TAVR
timeFrame: Baseline, 30-days post-TAVR
measure: Change in Grip Strength (Dynamometer) from Baseline to post-STEP
timeFrame: Baseline, 6-weeks
measure: Change in Grip Strength (Dynamometer) from Baseline to 30-days post-TAVR
timeFrame: Baseline, 30-days post-TAVR
measure: Change in Independent Activity (Katz Activities of Daily Living Survey) from Baseline to post-STEP
timeFrame: Baseline, 6-weeks
measure: Change in Independent Activity (Katz Activities of Daily Living Survey) from Baseline to to 30-days post-TAVR
timeFrame: Baseline, 30-days post-TAVR
measure: Change in Malnutrition (Serum Albumin Level) from Baseline to 30-days post-TAVR
timeFrame: Baseline, 30-days post-TAVR
Other outcomes:
Locations:
city: Peoria
country: United States
facility: OSF St. Francis Medical Center
state: Illinois
Study officials:
affiliation: OSF Healthcare System
name: Jay N Patel, MD
role: PRINCIPAL_INVESTIGATOR
References: