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In this pilot study, investigators aim to identify patients undergoing TAVR who are at elevated risk for adverse clinical events due to decreased exertional capacity and physical deconditioning. Investigators aim to determine if monitored pre-procedural physical therapy is safe in these patients. Lastly, investigators aim to assess the efficacy of prehabilitation
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-procedure standard of care | No Intervention | No prehab prior to TAVR. | |
| Prehab prior to TAVR procedure. | Active Comparator | Individuals participate in prehabilitation prior to TAVR. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-habilitation | Other | Eight - Twelve visits to physical therapy prior to their TAVR procedure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Functional exercise capacity - Change in 6 Minute Walk Test (6MWT) | Measure: Does prehabilitation improve the subject's functional exercise capacity from first PT assessment to pre-procedure assessment and first PT assessment to one month post-procedure, as measured by the 6MWT? | One month post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Mobility - Timed Up and Go Test (TUG) | Does prehabilitation improve the subject's mobility from first physical therapy assessment to pre-procedure assessment and first PT assessment to one month post-procedure, as measured by the TUG test? | One month |
| Balance - Four Square Step Test (FSST) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Harvey, MD | Wellspan York Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellspan York Hospital | York | Pennsylvania | 17403 | United States |
All individual participant data defined in the protocol will be collected during trial participation and entered in a secured Electronic Data Capturing System. All data shared or copied shared will only occur after complete deidentification. Participant data will be made available for Annual Data Safety Management Board (DSMB) committee review. The Study Protocol, Informed Consent Form, and applicable Case Report Forms will be available.
Immediately following publication. No End Date
Researchers who provide a methodologically sound proposal.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 26, 2022 | Apr 13, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 26, 2022 | Apr 13, 2022 | ICF_001.pdf |
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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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Comparing individuals who have prehabilitation prior to their TAVR procedure with those that do not.
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Does prehabilitation improve the subject's balance from first physical therapy assessment to preprocedure assessment and first PT assessment to one month post-procedure, as measured by the FSST? |
| One month |
| Discharge Disposition | Does prehabilitation make it less likely that a patient will require a higher level of care at discharge than they require prior to admission (for example, arrive from home and discharged to home)? | 24-48 hours post procedure |
| Length of stay in the ICU | Hours total spent in the ICU for TAVR procedure admission | TAVR procedure admission |
| Total hospital length of stay | Days total spent in the hospital for TAVR procedure admission | TAVR procedure admission |
| Change in Quality of Life (KCCQ) | Does the Kansas City Cardiomyopathy Questionnaire score change from the first physical therapy assessment to one month post-procedure? | One month |
| 30 day readmission | Does the subject have a 30 day re-admission post-procedure? | 30 days post procedure |
| D014694 |
| Ventricular Outflow Obstruction |