Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement

NCT03107897 | Completed DMC

• 1 other identifier: TAVR Prehab
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

1. 1.to improve physical functioning by the time of TAVR and to sustain benefit through 30 days post-procedure; and
2. 2.to determine its effect on post-procedural length-of-stay, clinical outcomes, and quality of life.

Conditions

Aortic Valve Stenosis

Keywords

TAVR; elevated frailty score; Transcatheter Valve Replacement

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Mobility - Timed Up and Go Test (TUG)

  One month

• Balance - Four Square Step Test (FSST)

  One month

• Discharge Disposition

  24-48 hours post procedure

• Length of stay in the ICU

  TAVR procedure admission

• Total hospital length of stay

  TAVR procedure admission

Study Arms (2)

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.

Other: Pre-habilitation

Interventions

Pre-habilitation OTHER

Eight - Twelve visits to physical therapy prior to their TAVR procedure.

Prehab prior to TAVR procedure.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• WellSpan Health: lead

Study Sites (1)

Wellspan York Hospital

York, Pennsylvania, 17403, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• James Harvey, MD

  Wellspan York Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Comparing individuals who have prehabilitation prior to their TAVR procedure with those that do not.

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: April 11, 2017
• Study Start: August 17, 2016
• Primary Completion: August 9, 2020
• Study Completion: April 30, 2021
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Immediately following publication. No End Date
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)