Prehabilitation for Patients Undergoing Transcatheter Aortic Valve Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-17

Study Completion Date

2021-04-30

Brief Summary

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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

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.

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Detailed Description

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Conditions

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Aortic Valve Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Pre-procedure standard of care

No prehab prior to TAVR.

Group Type NO_INTERVENTION

No interventions assigned to this group

Prehab prior to TAVR procedure.

Individuals participate in prehabilitation prior to TAVR.

Group Type ACTIVE_COMPARATOR

Pre-habilitation

Intervention Type OTHER

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

Interventions

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Pre-habilitation

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

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No