Back to resultsPrehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR-Prehab)
Primary Purpose
Aortic Valve Stenosis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre-habilitation
Sponsored by
About this trial
This is an interventional prevention trial for Aortic Valve Stenosis focused on measuring TAVR, elevated frailty score, Transcatheter Valve Replacement
Eligibility Criteria
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.
Sites / Locations
- Wellspan York Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Pre-procedure standard of care
Prehab prior to TAVR procedure.
Arm Description
No prehab prior to TAVR.
Individuals participate in prehabilitation prior to TAVR.
Outcomes
Primary Outcome Measures
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?
Secondary Outcome Measures
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?
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?
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)?
Length of stay in the ICU
Hours total spent in the ICU for TAVR procedure admission
Total hospital length of stay
Days total spent in the hospital for 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?
30 day readmission
Does the subject have a 30 day re-admission post-procedure?
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03107897
Brief Title
Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement
Acronym
TAVR-Prehab
Official Title
Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 17, 2016 (Actual)
Primary Completion Date
August 9, 2020 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
WellSpan Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
to improve physical functioning by the time of TAVR and to sustain benefit through 30 days post-procedure; and
to determine its effect on post-procedural length-of-stay, clinical outcomes, and quality of life.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
TAVR, elevated frailty score, Transcatheter Valve Replacement
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparing individuals who have prehabilitation prior to their TAVR procedure with those that do not.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-procedure standard of care
Arm Type
No Intervention
Arm Description
No prehab prior to TAVR.
Arm Title
Prehab prior to TAVR procedure.
Arm Type
Active Comparator
Arm Description
Individuals participate in prehabilitation prior to TAVR.
Intervention Type
Other
Intervention Name(s)
Pre-habilitation
Intervention Description
Eight - Twelve visits to physical therapy prior to their TAVR procedure.
Primary Outcome Measure Information:
Title
Functional exercise capacity - Change in 6 Minute Walk Test (6MWT)
Description
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?
Time Frame
One month post procedure
Secondary Outcome Measure Information:
Title
Mobility - Timed Up and Go Test (TUG)
Description
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?
Time Frame
One month
Title
Balance - Four Square Step Test (FSST)
Description
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?
Time Frame
One month
Title
Discharge Disposition
Description
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)?
Time Frame
24-48 hours post procedure
Title
Length of stay in the ICU
Description
Hours total spent in the ICU for TAVR procedure admission
Time Frame
TAVR procedure admission
Title
Total hospital length of stay
Description
Days total spent in the hospital for TAVR procedure admission
Time Frame
TAVR procedure admission
Title
Change in Quality of Life (KCCQ)
Description
Does the Kansas City Cardiomyopathy Questionnaire score change from the first physical therapy assessment to one month post-procedure?
Time Frame
One month
Title
30 day readmission
Description
Does the subject have a 30 day re-admission post-procedure?
Time Frame
30 days post procedure
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Harvey, MD
Organizational Affiliation
Wellspan York Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wellspan York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Immediately following publication. No End Date
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal.
Learn more about this trial
Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement
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