Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study)
Launched by JOHNS HOPKINS UNIVERSITY · Oct 24, 2023
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
The OPTIMAL Study is looking into ways to help patients recover and improve their activity levels after a procedure called transcatheter aortic valve replacement (TAVR). This study will test different programs to see which is most effective for helping patients feel better and move more after their surgery. Specifically, researchers will compare a motivation interviewing program, a combination of home-based physical activity and motivation interviewing, and the usual care that includes extra education.
To participate in this study, patients need to be at least 65 years old, undergoing the TAVR procedure, and able to move around independently without assistance. They should also have access to a phone or video conferencing for follow-ups. Patients who have significant health issues that limit their ability to exercise, cognitive impairments, or high fall risks may not be eligible. Those who join will receive support to encourage them to be more active and can expect regular check-ins to monitor their progress. This study is currently recruiting participants, and it aims to find effective ways to enhance recovery after TAVR.
Gender
ALL
Eligibility criteria
- Inclusion 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
- Exclusion Criteria:
- • 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
About Johns Hopkins University
Johns Hopkins University, a prestigious research institution located in Baltimore, Maryland, is renowned for its commitment to advancing medical science and public health through innovative clinical trials. With a rich history of groundbreaking research and a multidisciplinary approach, the university's clinical trial initiatives focus on translating scientific discoveries into effective treatments and interventions. Leveraging state-of-the-art facilities and a collaborative network of experts, Johns Hopkins University conducts rigorous clinical studies that aim to improve patient outcomes and address critical health challenges. Its dedication to ethical standards and participant safety underscores its role as a leader in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Baltimore, Maryland, United States
Patients applied
Trial Officials
Charles Brown, MD
Study Director
Johns Hopkins Uiversity
Giancarlo Suffredini, MD
Principal Investigator
Johns Hopkins University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported