Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement (TAVR-Prehab)

WellSpan Health

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Other: Pre-habilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03107897

TAVR Prehab

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

35 participants in 2 patient groups

Pre-procedure standard of care

No Intervention group

Description:

No prehab prior to TAVR.

Prehab prior to TAVR procedure.

Active Comparator group

Description:

Individuals participate in prehabilitation prior to TAVR.

Treatment:

Other: Pre-habilitation