RECRUITING

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 DiseaseAortic Valve Replacement
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Related Conditions:

Aortic Valve DiseaseAortic Valve Replacement

Study Overview

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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