Skip to main content
OpenTrials
Completed

NCT Number: NCT06106451

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aortic Valve Disease Aortic Valve Replacement Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Johns Hopkins University

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard of Care plus Enhanced Patient Education

Behavioral

Patients in this arm will receive a pamphlet explaining the benefits of cardiac rehabilitation. This pamphlet will be given in addition to standard of care patient education. The research team will also call the patient at four specified time points to provide additional information.

Motivational Interviewing Intervention

Behavioral

Patients in this arm of the study will participate in a tailor-made motivational interviewing program. These motivational interviewing sessions will focus on enhancing communication with patients. Each motivational interviewing session will be approximately one hour long. There will be a total of 4-6 motivational interviewing sessions.

Home-Based Activity Program plus Motivational Interviewing Intervention

Behavioral

Patients in this arm will be evaluated on postoperative day 1 by a physical therapist on the study team. After the evaluation, the physical therapist will use the information from the evaluation to make a tailored home-based physical activity program for the patient. The patient will begin the home-based physical activity program on the day of their 1-month post-operative cardiology clinic appointment. In addition to the home-based activity program, patients will participate in a tailor-made motivational interviewing program. These motivational interviewing sessions will focus on enhancing communication with patients. Each motivational interviewing session will be approximately one hour long. There will be a total of 4-6 motivational interviewing sessions.

Primary outcomes

  1. Number of motivational interviewing sessions attended

    Time frame: Approximately 20 weeks after the day of the TAVR procedure

    This outcome will measure the number of motivational interviewing sessions in which the patient participates. Motivational Interviewing Arm Outcome.

  2. Number of home-based activity sessions attended

    Time frame: Approximately 20 weeks after the day of the TAVR procedure

    This outcome will measure the number of home-based activity sessions the patient logs. Home-based Activity Arm

Secondary outcomes

  1. Number of Cardiac Rehabilitation Sessions Attended

    Time frame: Approximately 20 weeks after the day of the TAVR procedure

    This outcome will measure the number of cardiac rehabilitation sessions attended by the participant.

  2. Number of Barriers to Attending Cardiac Rehabilitation Sessions

    Time frame: Approximately 20 weeks after the day of the TAVR procedure

    This outcome will measure any self-reported barriers that patients experience to participating in cardiac rehabilitation sessions.

  3. Health Status as assessed by the EuroQol 5 Dimension 5 Level (EQ-5D-5L)

    Time frame: Approximately 20 weeks after the day of the TAVR procedure

    This survey is a standardized measure of health status. This survey is scored in two separate sections. The first section measures the five dimensions mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The first section is measured by a minimum score of 5 and a maximum score of 25. Higher score greater level of problems. The second section measures self report health status on a 0 to 100. Higher score best health.

  4. Health Status as assessed by the The Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: 20 weeks after the day of the TAVR procedure

    The Kansas City Cardiomyopathy Questionnaire (KCCQ) is a survey used to measure health status in patients with heart failure. The KCCQ scores four domains and one summary score. The four domains are physical limitations score, symptom frequency score, quality of life score, and the social limitations score. These five scores are scaled on a scale of 0 to 100. Higher score better health status.

  5. Disability as assessed by the World Health Organization Disability Assessment Schedule (WHO-DAS 2.0)

    Time frame: Approximately 20 weeks after the day of the TAVR procedure

    This survey measures disability due to health conditions including diseases, illnesses, injuries, mental or emotional problems, and problems with alcohol and drugs. This survey has a minimum score of 12 and a maximum score of 60. Higher scores more disability.

  6. Potential Depression as assessed by the Geriatric Depression Scale

    Time frame: 20 weeks after the day of the TAVR procedure

    This survey is a self-reported measure of potential depression in older adults. The minimum score for this survey is 0 and the maximum score is 15. A score of 5 or greater suggests depression.

  7. Safety Events

    Time frame: Approximately 20 weeks after the day of the TAVR procedure

    Any events adverse events or serious adverse events that occur while the patient is participating in the study.

  8. Number of steps as assessed by the 2-Minute Step Test

    Time frame: Approximately 20 weeks after the day of the TAVR procedure

    This test measures the number of steps the patient can take in 2 minutes time. The number of steps recorded is compared to a standardized range of steps based on age.

  9. Number of stands from sitting as assessed by the 30-Second Chair Rise

    Time frame: Approximately 20 weeks after the day of the TAVR procedure

    This test records the number of stands from sitting the patient can complete in 30 seconds time. The number of stands the patient can complete is compared to the average number is compared to the average number in the patient's age group.

  10. The Duration of the Motivational Interviewing Sessions

    Time frame: Approximately 20 weeks after the day of the TAVR procedure

    This outcome will measure the length of each motivational interviewing session attended.

  11. Patient Satisfaction With the Assigned Program

    Time frame: Approximately 20 weeks after the day of the TAVR procedure

    Patient satisfaction will be measured using a Likert scale from 1 to 5. 1 indicates the patient is very dissatisfied. 5 indicates the patient is very satisfied.

  12. Number of Contacts with the Study Physical Therapist

    Time frame: Approximately 20 weeks after the day of the TAVR procedure

    This outcome measure the number of times the patient has contact with the study physical therapy.

  13. Number of steps taken as assessed by Fitbit Data

    Time frame: Approximately 20 weeks after the day of the TAVR procedure

    This outcome will measure activity (e.g. number of steps taken) while wearing the Fitbit during periods of valid wear.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Catalyst Foundation

Registry information

Acronym: OPTIMAL

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 30, 2023
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.