Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study)

Description

In this study, the investigators will evaluate the feasibility and potential efficacy of programs to improve functional outcomes after minimally-invasive transcatheter aortic valve replacement (TAVR). The investigators will examine the potential efficacy of (a) a motivation interviewing program, and (b) a home-based physical activity + motivational interviewing program, compared to (c) usual care + enhanced education in patients post-TAVR procedure.

Conditions

Aortic Valve Disease, Aortic Valve Replacement

Talk to us

Study Overview

On this page

Study Details

Study overview

In this study, the investigators will evaluate the feasibility and potential efficacy of programs to improve functional outcomes after minimally-invasive transcatheter aortic valve replacement (TAVR). The investigators will examine the potential efficacy of (a) a motivation interviewing program, and (b) a home-based physical activity + motivational interviewing program, compared to (c) usual care + enhanced education in patients post-TAVR procedure.

Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study)

Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study)

Condition
Aortic Valve Disease
Intervention / Treatment

-

Contacts and Locations

Baltimore

The Johns Hopkins University, Baltimore, Maryland, United States, 21287

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Undergoing TAVR procedure
  • * ≥65 years old
  • * Ambulatory at baseline without assistance
  • * Approval of the interventional cardiologist that the patient is an appropriate candidate
  • * Can access telephone or teleconference
  • * Impaired cognition that would limit participation in study activities
  • * Medical comorbidities that substantially limit exercise
  • * Major cardiac comorbidities, including ejection fraction\<35%, history of cardiac arrest, complex dysrhythmias at rest, clinically-significant incomplete revascularization, implanted cardiac defibrillator.
  • * Physical characteristics that substantially limit exercise
  • * High fall risk (Johns Hopkins Fall Risk Assessment Tool indicating high risk)
  • * Non-English Speaking
  • * Vigorous exercise at least 2 times/week for \>30 minutes
  • * Any other physician judgement

Ages Eligible for Study

65 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Johns Hopkins University,

Charles Brown, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins Uiversity

Study Record Dates

2027-04-01