Improving activity levels after aortic valve replacement
Optimization Post-TAVR to IMprove Activity Levels (OPTIMAL Study)
This study is testing whether a special program that combines motivation and home exercise can help people recover and be more active after getting a new heart valve through a minimally-invasive procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06106451 on ClinicalTrials.gov |
What this trial studies
This study evaluates programs designed to enhance functional outcomes for patients following minimally-invasive transcatheter aortic valve replacement (TAVR). It compares the effectiveness of a motivational interviewing program and a home-based physical activity program combined with motivational interviewing against standard care with enhanced education. The goal is to determine which approach best supports recovery and activity levels in patients post-TAVR.
Who should consider this trial
Good fit: Ideal candidates are patients aged 65 and older who are undergoing a TAVR procedure and are ambulatory without assistance.
Not a fit: Patients with significant cognitive impairments, major cardiac comorbidities, or those who engage in vigorous exercise regularly may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved recovery and increased activity levels for patients after aortic valve replacement.
How similar studies have performed: Other studies have shown promising results with motivational interviewing and physical activity interventions in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Baltimore, Maryland
- The Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Giancarlo Suffredini, MD — Johns Hopkins University
- Study coordinator: Charles Brown, MD
- Email: cbrownv@jhmi.edu
- Phone: 410-955-9918
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.