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| Name | Class |
|---|---|
| HeartCare Midwest | UNKNOWN |
| University of Illinois College of Medicine at Peoria | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supervised TAVR Exercise Program (STEP) | Experimental | 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. |
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| Standard of Care | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supervised TAVR Exercise Program | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Frailty Score from Baseline to post-STEP | Baseline, 6-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | 6-weeks | |
| Change in Frailty Score from Baseline to 30-days post-TAVR | Baseline, 30-days post-TAVR | |
| Change in Gait Speed (5-Meter Walk Test) from Baseline to post-STEP |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay N Patel, MD | OSF Healthcare System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OSF St. Francis Medical Center | Peoria | Illinois | 61630 | United States |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 post-STEP | Baseline, 6-weeks |
| 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 post-STEP | Baseline, 6-weeks |
| 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 Malnutrition (Serum Albumin Level) from Baseline to 30-days post-TAVR | Baseline, 30-days post-TAVR |
| D014694 |
| Ventricular Outflow Obstruction |