Home-Based Activity and Motivation Program for Aortic Valve Replacement Recovery

(OPTIMAL Trial)

Overseen By Mirinda Anderson White, RN

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Impaired cognition, Major cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

55 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for aortic valve replacement recovery?

Research shows that home-based cardiac rehabilitation (HBCR) after transcatheter aortic valve replacement (TAVR) can improve exercise tolerance, functional independence, and quality of life. Additionally, HBCR is associated with lower mortality rates in patients with cardiovascular disease, suggesting it may be beneficial for those recovering from TAVR. ^{1 2 3 4 5}

Is the Home-Based Activity and Motivation Program for Aortic Valve Replacement Recovery safe for humans?

Research on home-based cardiac rehabilitation programs, including those with motivational components, suggests they are generally safe for patients recovering from aortic valve procedures. These programs have been shown to improve exercise tolerance and quality of life without significant safety concerns. ^{2 3 4 6 7}

How is the Home-Based Activity and Motivation Program for Aortic Valve Replacement Recovery different from other treatments?

This treatment is unique because it is a home-based program designed to improve recovery after aortic valve replacement by increasing exercise tolerance and quality of life, while overcoming barriers like transportation and cost that limit access to traditional rehabilitation programs. ^{2 3 4 7 8}

Research Team

Giancarlo Suffredini, MD

Principal Investigator

Johns Hopkins University

Charles Brown, MD

Principal Investigator

Johns Hopkins Uiversity

Eligibility Criteria

This trial is for individuals aged 65 or older who are undergoing a TAVR procedure, can walk without help, have their cardiologist's approval to participate, and can use a phone or teleconference. It excludes those with severe cognitive issues, major heart problems like low ejection fraction or cardiac arrest history, high fall risk, regular vigorous exercisers, non-English speakers, and any other conditions deemed unsuitable by a physician.

Inclusion Criteria

I am scheduled for a TAVR procedure.

I can walk by myself without help.

I am 65 years old or older.

Exclusion Criteria

You have physical traits that make it difficult for you to exercise.

I have health issues that significantly limit my ability to exercise.

My thinking or memory problems do not prevent me from participating in study activities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Post-TAVR Recovery

Participants undergo initial recovery and stabilization post-TAVR procedure

2 weeks

Intervention

Participants engage in motivational interviewing, home-based physical activity, or enhanced education programs

18 weeks

4 visits (in-person), multiple virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

Treatment Details

Interventions

• Home-Based Activity Program plus Motivational Interviewing Intervention
• Motivational Interviewing Intervention
• Standard of Care plus Enhanced Patient Education

Trial Overview The study tests the effectiveness of two programs aimed at improving activity levels after TAVR: one combines home-based exercises with motivational talks; another just uses motivational talks. These will be compared against standard care plus extra patient education to see which is best at helping patients recover.

Participant Groups

Group I: Motivational Interviewing Intervention Active Control 1 Intervention

Each participant in this arm will have a motivational interviewing program created by a psychologist. The motivational interviewing program will be tailored to the individual participant. The goal of the motivational interviewing program is improved adherence to standard of care cardiac rehabilitation. The motivational interviewing program will begin approximately 2 weeks after the TAVR procedure.

Group II: Standard of Care plus Enhanced Patient Education Active Control 1 Intervention

Each participant in this arm will receive enhanced patient education. The research staff will discuss the benefits of cardiac rehabilitation and provide a pamphlet describing the benefits discussed. The research staff will also call the patient four times throughout their participation in the study to encourage physical activity. The enhanced patient education program will begin approximately 2 weeks after the TAVR procedure.

Group III: Home-Based Activity Program plus Motivational Interviewing Intervention Active Control 1 Intervention

Each participant in this arm will be evaluated by a physical therapist and psychologist. The physical therapist will use the evaluation to create an individually tailored home-based activity program plan. This home-based activity program will be implemented at the 1-month post-operative cardiology clinic appointment. The psychologist will use the evaluation to create an individually tailored motivational interviewing program. The motivational interviewing program will begin approximately 2 weeks after the TAVR procedure.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Catalyst Foundation

Collaborator

Trials

1

Recruited

60+

Findings from Research

In a study of 1120 patients eligible for cardiac rehabilitation, those who participated in home-based cardiac rehabilitation (HBCR) had a 36% lower risk of mortality compared to nonparticipants, indicating a significant safety and efficacy benefit of HBCR.

The study followed patients for a median of 4.2 years, revealing that 12% of HBCR participants died compared to 20% of nonparticipants, suggesting that HBCR can be a valuable alternative for patients unable to attend traditional facility-based programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Home-Based Cardiac Rehabilitation With Lower Mortality in Patients With Cardiovascular Disease: Results From the Veterans Health Administration Healthy Heart Program. Krishnamurthi, N., Schopfer, DW., Shen, H., et al.[2023]

A 12-week home-based cardiac rehabilitation (HBCR) program for post-TAVR patients significantly improved physical functioning, as evidenced by better scores in the Duke Activity Survey Index and Short Form-36 health survey after participation.

Out of 59 patients offered the HBCR program, 28 completed it, demonstrating that home-based rehabilitation can effectively increase participation by overcoming barriers like transportation and access to traditional rehabilitation facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-Based Cardiac Rehabilitation (HBCR) In Post-TAVR Patients: A Prospective, Single-Center, Cohort, Pilot Study. Bhattal, GK., Park, KE., Winchester, DE.[2021]

A home-based cardiac rehabilitation program enhances access and enrollment for patients, making it easier for them to participate in their recovery.

This program utilizes an evidence-based alternative model of care, which suggests it is grounded in proven methods for improving heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Design and Implementation of a Home-Based Cardiac Rehabilitation Program. Rohrbach, G., Schopfer, DW., Krishnamurthi, N., et al.[2020]

A home-based mobile health exercise intervention for patients after transcatheter aortic valve replacement (TAVR) did not significantly improve overall daily steps or physical performance for the entire group of 50 participants, average age 76.

However, the intervention showed positive effects on daily activity levels, particularly for those who did not participate in traditional cardiac rehabilitation, indicating it may be beneficial as an alternative approach for improving physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a pragmatic home-based mobile health exercise intervention after transcatheter aortic valve replacement: a randomized pilot trial. Lindman, BR., Gillam, LD., Coylewright, M., et al.[2023]

A quality improvement initiative significantly increased cardiac rehabilitation referral rates after transcatheter aortic valve replacement (TAVR) from 5% to 56% over 18 months, highlighting the importance of structured programs in improving patient outcomes.

Education for healthcare providers and involvement of cardiac rehabilitation staff during discharge rounds were key strategies that led to a dramatic rise in referrals, particularly from 0.8% to 53% before hospital discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac Rehabilitation Referral After Transcatheter Aortic Valve Replacement. Nusbickel, AJ., Randall, MH., Plasschaert, JM., et al.[2023]

In a study of 66 patients who underwent transcatheter aortic valve replacement (TAVR), moderate-intensity continuous training (MICT) significantly improved peak oxygen consumption (peak VO2) after 3 months compared to a control group, indicating enhanced cardiopulmonary function.

The MICT group also showed a notable improvement in the 6-minute walk test (6MWT) and a reduction in low-density lipoprotein cholesterol levels, suggesting benefits in physical capacity and cardiovascular health post-TAVR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Moderate-Intensity Continuous Training on the Improvement of Cardiopulmonary Function in Patients After Transcatheter Aortic Valve Replacement (ENERGY): A Randomized Controlled Trial. Hu, Q., Li, YS., Ren, Q., et al.[2023]

Exercise-based cardiac rehabilitation (CR) likely improves exercise capacity in patients who have undergone transcatheter aortic valve implantation (TAVI) or surgical aortic valve replacement (SAVR), based on a systematic review of six studies involving 255 patients.

The studies showed moderate certainty evidence for the benefits of exercise-based CR, but further large-scale, long-term randomized controlled trials are needed to evaluate its overall clinical and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise-based cardiac rehabilitation for patients following open surgical aortic valve replacement and transcatheter aortic valve implant: a systematic review and meta-analysis. Anayo, L., Rogers, P., Long, L., et al.[2023]

Intensive cardiac rehabilitation after transcatheter aortic valve implantation (TAVI) is safe and leads to significant improvements in disability, fall risk, and exercise capacity, similar to outcomes seen in older patients who underwent surgical valve replacement (sAVR).

Despite these improvements, TAVI patients exhibited higher levels of disability and comorbidity compared to sAVR patients, indicating that while rehabilitation is beneficial, TAVI patients may still face greater challenges in recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation after transcatheter aortic valve implantation compared to patients after valve replacement. Tarro Genta, F., Tidu, M., Bouslenko, Z., et al.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

Association of Home-Based Cardiac Rehabilitation With Lower Mortality in Patients With Cardiovascular Disease: Results From the Veterans Health Administration Healthy Heart Program. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Home-Based Cardiac Rehabilitation (HBCR) In Post-TAVR Patients: A Prospective, Single-Center, Cohort, Pilot Study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

The Design and Implementation of a Home-Based Cardiac Rehabilitation Program. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Effect of a pragmatic home-based mobile health exercise intervention after transcatheter aortic valve replacement: a randomized pilot trial. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Cardiac Rehabilitation Referral After Transcatheter Aortic Valve Replacement. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Moderate-Intensity Continuous Training on the Improvement of Cardiopulmonary Function in Patients After Transcatheter Aortic Valve Replacement (ENERGY): A Randomized Controlled Trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Exercise-based cardiac rehabilitation for patients following open surgical aortic valve replacement and transcatheter aortic valve implant: a systematic review and meta-analysis. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Cardiac rehabilitation after transcatheter aortic valve implantation compared to patients after valve replacement. [2017]