Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement

Aortic Valve Stenosis Clinical Trial

— TAVR-Prehab  

Official title:

Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03107897
• Other study ID #: TAVR Prehab
• Status: Completed
• Phase: N/A
• Start date: August 17, 2016
• Est. completion date: April 30, 2021

Study information

• Verified date: June 2023
• Source: WellSpan Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

1. to improve physical functioning by the time of TAVR and to sustain benefit through 30 days post-procedure; and

2. to determine its effect on post-procedural length-of-stay, clinical outcomes, and quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 30, 2021
• Est. primary completion date: August 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subject must be ambulatory (with or without an assist device)

• Subject has severe aortic stenosis and is felt an appropriate candidate for TAVR by the Heart Team.

• Subject requires 6.0 seconds or longer to complete a 15ft walk test

• Subject must be able to move between sitting and standing without assistance from another person.

• Subject has adequate iliac and femoral arterial anatomy to allow for TAVR via transfemoral access

• Subject is 18 years of age or greater

• Subject is willing to give consent and participate in the study

Exclusion Criteria:

• Subject is incapable of following instructions

• Subject is unable to meet the minimum required physical therapy visits

• Subject has other medical conditions rendering it unsafe, in the opinion of the Principal Investigator and physical therapy staff, to perform a 6 Minute Walk Test or physical therapy conditioning prior to TAVR

• Subject has significant severe un-revascularized epicardial coronary disease.

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Other:
• Pre-habilitation
Eight - Twelve visits to physical therapy prior to their TAVR procedure.

Locations

Country	Name	City	State
United States	Wellspan York Hospital	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
WellSpan Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Balance - Four Square Step Test (FSST)	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
Secondary	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
Secondary	Length of stay in the ICU	Hours total spent in the ICU for TAVR procedure admission	TAVR procedure admission
Secondary	Total hospital length of stay	Days total spent in the hospital for TAVR procedure admission	TAVR procedure admission
Secondary	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
Secondary	30 day readmission	Does the subject have a 30 day re-admission post-procedure?	30 days post procedure