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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve recovery after transcatheter aortic valve replacement (TAVR), a procedure to repair a heart valve. Researchers are testing three approaches: a motivational interviewing program, a home-based physical activity program combined with motivational interviewing, and usual care with additional education. The goal is to determine which method best enhances recovery and physical activity after surgery. Individuals who have undergone TAVR, can walk unaided, and have access to a phone or computer may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative recovery strategies and potentially enhance their own recovery process.

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 prior data suggests that these programs are safe for post-TAVR recovery?

Research has shown that home-based cardiac rehab programs are generally safe for people recovering from transcatheter aortic valve replacement (TAVR). Studies have found that these programs can enhance exercise ability and quality of life without major safety concerns.

One 12-week home-based program significantly improved physical functioning in patients after TAVR, indicating it is well-tolerated. This suggests that incorporating motivational interviewing, a method to encourage adherence to rehab, may also be safe, as it has been used effectively without serious side effects.

Overall, these programs aim to aid recovery and are considered safe based on current research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to boost recovery after aortic valve replacement through personalized support and motivation. Unlike the standard cardiac rehab, which typically involves general physical activity guidelines and education, this trial tests a home-based activity program tailored by a physical therapist, combined with personalized motivational interviewing by a psychologist. This approach aims to enhance adherence to rehabilitation by addressing individual needs and motivations, potentially leading to better recovery outcomes. By focusing on personalized motivation and home-based activity, researchers hope to find more effective methods to help patients regain their health more quickly and comfortably.

What evidence suggests that this trial's programs could be effective for aortic valve replacement recovery?

Research has shown that a home-based exercise program, combined with motivational support, can enhance recovery after transcatheter aortic valve replacement (TAVR). In this trial, participants in the Home-Based Activity Program plus Motivational Interviewing Intervention arm will receive a tailored home-based exercise plan and motivational support. A 12-week home-based cardiac rehab program for these patients led to noticeable improvements in their physical abilities. Studies also suggest that motivational support encourages patients to adhere to their rehab, which is crucial for recovery. Another study found that starting exercise programs at home soon after TAVR can help older adults avoid disability and improve their physical abilities. These findings highlight the potential benefits of both physical activity and motivational support in enhancing recovery after TAVR. ^{1 2 3 4 6}

Who Is on the Research Team?

Charles Brown, MD

Principal Investigator

Johns Hopkins Uiversity

Giancarlo Suffredini, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06106451

Optimization Post-TAVR to IMprove Activity Levels ... The investigators will examine the potential efficacy of (a) a motivation interviewing program, and (b) a home-based physical activity + motivational ...

2. withpower.com withpower.com/trial/phase-aortic-valve-disease-10-2023-cc83d

Home-Based Activity and Motivation Program for Aortic ... A 12-week home-based cardiac rehabilitation (HBCR) program for post-TAVR patients significantly improved physical functioning, as evidenced by better scores in ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40171799/

Home-Based Rehabilitation After Transcatheter Aortic Valve ... An early, home-based, multi-domain exercise program appears feasible and may prevent disability and improve physical function in older adults after TAVR.

4. researchgate.net researchgate.net/publication/378823434_Home-based_mobile-guided_exercise-based_cardiac_rehabilitation_among_patients_undergoing_transcatheter_aortic_valve_replacement_REHAB-TAVR_protocol_for_a_randomised_clinical_trial

protocol for a randomised clinical trial This study aims to assess the effectiveness of home-based mobile-guided exercise-based cardiac rehabilitation in TAVR patients, led by a ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02805309

Home-Based Exercise Program For Recovery After ... We hypothesize that a home-based exercise program with cognitive behavioral intervention is more effective than home-based exercise alone; home-based exercise ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7584688/

Home-Based Cardiac Rehabilitation (HBCR) In Post-TAVR ... Cardiac rehabilitation after transcatheter aortic valve replacement (TAVR) safely improves exercise tolerance, functional independence, and quality of life.