Virtual PREHAB for Cardiovascular Disease

Overseen By Scott Kehler, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Heart failure, Severe limitations, Cognitive impairment, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if virtual PREHAB (pre-surgery rehabilitation) can safely help patients with frailty improve their health before undergoing transcatheter aortic valve implantation (TAVI). TAVI is a less invasive procedure for patients too frail for open-heart surgery. The trial will compare standard care before TAVI with additional virtual PREHAB, delivered online or by phone by a team of healthcare providers. This approach is particularly beneficial for patients who find it difficult to travel for in-person PREHAB sessions. Ideal participants are those attending the TAVI clinic at Queen Elizabeth II Health Sciences Centre, who have no severe functional limitations and can access the internet or a phone. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies that could enhance pre-surgery preparation for frail patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that virtual PREHAB is safe for patients before TAVI?

Research shows that virtual cardiac prehabilitation (PREHAB), which involves exercising and managing health from home, is generally safe for patients. A detailed review of remote cardiac rehabilitation programs found that most patients handle them well, with no major safety issues reported. Other studies on similar virtual programs have shown they can improve quality of life and reduce anxiety without causing serious side effects.

Although this specific virtual PREHAB program hasn't been studied yet, research on similar programs suggests they are safe for heart patients. Healthcare professionals monitor this treatment to quickly address any problems. Overall, virtual PREHAB appears to be a safe option for those preparing for heart procedures like transcatheter aortic valve implantation (TAVI). ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtual PREHAB for cardiovascular disease because it offers a unique approach to cardiac rehabilitation by delivering the program virtually. Unlike traditional cardiac rehab, which typically requires in-person sessions, Virtual PREHAB allows patients to receive care from a team of healthcare professionals, including a nurse, dietician, and physiotherapist, entirely online or by phone. This makes the program more accessible and convenient, especially for individuals who may have difficulty attending in-person sessions due to location, mobility, or scheduling constraints. Additionally, Virtual PREHAB provides a comprehensive 8-week program that mirrors the core components of standard cardiac rehab, potentially leading to improved patient adherence and outcomes.

What evidence suggests that virtual PREHAB is effective for reducing frailty before TAVI?

Research has shown that virtual cardiac rehabilitation (rehab) can effectively improve health for heart patients. One study found that patients using virtual rehab attended more sessions and engaged more than those in in-person programs. Another study found that both virtual and traditional rehab reduced anxiety and depression and kept patients motivated. Virtual rehab also led to fewer hospital visits, indicating better overall health. In this trial, participants will be assigned to either the Virtual PREHAB program or standard care. These findings suggest that virtual PREHAB might help frail patients prepare for heart procedures like TAVI, potentially improving their recovery and health. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for outpatients in Nova Scotia who are frail and awaiting a less invasive heart valve surgery called TAVI. They must be able to give informed consent. It's not clear who can't join because the exclusion criteria aren't listed.

Inclusion Criteria

Outpatients attending the TAVI clinic at the Queen Elizabeth II Health Sciences Centre

Informed written or verbal consent

Exclusion Criteria

I have severe difficulties performing daily activities.

I can make decisions about my health care.

Significant language barrier

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Virtual PREHAB

Participants receive a virtually delivered preoperative rehabilitation program to reduce frailty before TAVI

8 weeks

Delivered online or by telephone

TAVI Procedure

Participants undergo the transcatheter aortic valve implantation procedure

Hospital stay up to 14 days

Follow-up

Participants are monitored for safety and effectiveness after the TAVI procedure

3 months

Regular follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Standard care
• Virtual PREHAB

Trial Overview

The study tests if virtual PREHAB (preoperative cardiac rehabilitation) at home can improve health before TAVI, compared to standard care. Healthcare providers deliver this program virtually to see if it helps reduce frailty safely and feasibly.

How Is the Trial Designed?

Group I: Virtual PREHAB Experimental Treatment 1 Intervention

In addition to standard care, participants randomized to the The virtual PREHAB program will be delivered by the Hearts and Health in Motion cardiac rehabilitation CR health care team including a medical director nurse, dietician, and physiotherapist who routinely deliver CR postoperatively. The virtual PREHAB program will be up to 8-weeks in duration and deliver the core components of CR online or by telephone.

Group II: Standard Care Active Control 1 Intervention

Virtual PREHAB is already approved in Canada for the following indications:

Approved in Canada as Virtual PREHAB for:

• Preoperative care for patients undergoing TAVI

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Published Research Related to This Trial

In a study of 20 patients undergoing cardiac rehabilitation after coronary artery bypass grafting, those using a virtual reality (VR) program reached their heart rate target goals significantly faster than those in a traditional program, with 9 out of 10 VR participants achieving their goals in 9 sessions or fewer.

The VR group also demonstrated superior performance in reaching metabolic targets, with all participants achieving the target metabolic cost after just 1 or 2 sessions, compared to 15 sessions for most control participants, indicating that VR can enhance recovery in cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a virtual reality-enhanced exercise protocol after coronary artery bypass grafting. Chuang, TY., Sung, WH., Chang, HA., et al.[2019]

A comprehensive personalized teleprehabilitation program for patients scheduled for elective cardiac surgery aims to reduce major adverse cardiac events (MACE) and improve post-operative outcomes, utilizing a multidisciplinary approach over at least 6 weeks.

The program includes various modules such as exercise training, nutritional support, and psychological assistance, and is designed to address perioperative risk factors, potentially leading to better recovery and quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalized teleprehabilitation in elective cardiac surgery: a study protocol of the Digital Cardiac Counselling randomized controlled trial. Scheenstra, B., Mohansingh, C., Bongers, BC., et al.[2023]

In a study involving 815 patients scheduled for elective cardiothoracic surgery, 52% did not participate in a digital prehabilitation trial, highlighting significant barriers to access such as lack of internet or digital skills.

The non-participating patients were often older, had lower socioeconomic status, were more likely to be current smokers, and had a higher EuroSCORE II, indicating they had more modifiable risk factors and could benefit the most from prehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reasons and predictors of non-participation in a personalized digital prehabilitation care trial for patients undergoing elective cardiothoracic surgery. Scheenstra, B., Bongers, BC., Broeders, B., et al.[2023]

The PRECOVERY trial will assess the effects of a 2-week multimodal prehabilitation program on 422 patients aged 75 and older undergoing elective cardiac procedures, aiming to improve quality of life and reduce mortality after 12 months.

This study is significant as it is the largest trial of its kind in Germany, addressing the need for a structured cardiac prehabilitation program for older patients, which currently does not exist.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation in older patients prior to elective cardiac procedures (PRECOVERY): study protocol of a multicenter randomized controlled trial. Steinmetz, C., Heinemann, S., Kutschka, I., et al.[2023]

In a study of 78 patients undergoing elective cardiovascular surgery, those identified as frail using the Kaigo-Yobo Check-List were more likely to experience delayed progress in cardiac rehabilitation, indicating its effectiveness as a predictive tool.

The study found that patients with delayed cardiac rehabilitation had poorer nutritional status and lower levels of serum hemoglobin and albumin, highlighting the importance of these factors in recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative frailty is associated with progression of postoperative cardiac rehabilitation in patients undergoing cardiovascular surgery. Arai, Y., Kimura, T., Takahashi, Y., et al.[2020]

Cardiac telerehabilitation significantly improves long-term cardiopulmonary fitness in patients with coronary artery disease (CAD), showing a mean difference of 1.61 in peak oxygen uptake compared to traditional center-based rehabilitation.

Patients participating in cardiac telerehabilitation also experience an improvement in quality of life, with a mean difference of 0.92, while maintaining a high completion rate of 80% and a low incidence of adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longer-Term Effects of Cardiac Telerehabilitation on Patients With Coronary Artery Disease: Systematic Review and Meta-Analysis. Zhong, W., Liu, R., Cheng, H., et al.[2023]

The PrEPS trial is a randomized controlled study involving 180 participants undergoing elective cardiac surgery, aiming to assess the feasibility and impact of a prehabilitation program that includes exercise and inspiratory muscle training on preoperative functional exercise capacity.

The primary outcome will measure changes in functional exercise capacity using the 6-minute walk test, while secondary outcomes will evaluate various factors such as respiratory function, quality of life, and postoperative complications, potentially improving overall patient outcomes before and after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation in elective patients undergoing cardiac surgery: a randomised control trial (THE PrEPS TRIAL) - a study protocol. Akowuah, E., Mathias, A., Bardgett, M., et al.[2023]

Prehabilitation programs for older patients awaiting elective cardiac surgery can significantly reduce hospital stay, intensive care unit time, and postoperative complications while enhancing quality of life after surgery.

These programs should include a combination of nutrition, exercise, and stress reduction techniques to boost patient resilience, but more high-quality research is needed to explore their effectiveness in diverse and frail populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation: The Right Medicine for Older Frail Adults Anticipating Transcatheter Aortic Valve Replacement, Coronary Artery Bypass Graft, and Other Cardiovascular Care. Boreskie, KF., Hay, JL., Kehler, DS., et al.[2020]

The virtual world-based cardiac rehabilitation program, Destination Rehab, was found to be feasible and highly acceptable among adult cardiac patients, with 93% attending at least one session and 71% attending 75% or more of the sessions.

While the program showed promising trends in improving cardiovascular health behaviors and biometrics, these changes were not statistically significant, indicating further research is needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Community-Informed Virtual World-Based Cardiac Rehabilitation Program as an Extension of Center-Based Cardiac Rehabilitation: MIXED-METHODS ANALYSIS OF A MULTICENTER PILOT STUDY. Brewer, LC., Abraham, H., Kaihoi, B., et al.[2023]

A home-based pre-operative rehabilitation (PREHAB) program for patients awaiting elective cardiac surgery showed significant improvements in physical function, including a reduction in clinical frailty scores and increased walking distance and speed, with no reported adverse events.

The study suggests that PREHAB may help reduce hospital length of stay for frail patients undergoing CABG or valve surgery, indicating its potential efficacy, but further research with a larger randomized controlled trial is needed to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based preoperative rehabilitation (prehab) to improve physical function and reduce hospital length of stay for frail patients undergoing coronary artery bypass graft and valve surgery. Waite, I., Deshpande, R., Baghai, M., et al.[2022]

The cardiac prehabilitation (Prehab) program for patients awaiting elective coronary artery bypass graft (CABG) surgery showed promising results, with participants increasing their walking distance significantly compared to those receiving standard care.

Prehab participants also demonstrated improved gait speed and had a higher enrollment rate in cardiac rehabilitation three months post-surgery, indicating both feasibility and potential benefits for patient recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation program for elective coronary artery bypass graft surgery patients: a pilot randomized controlled study. Sawatzky, JA., Kehler, DS., Ready, AE., et al.[2022]

Preoperative exercise training, or prehabilitation, is associated with improved clinical outcomes such as shorter hospital stays and fewer postoperative complications in patients undergoing cardiac and vascular surgeries, based on a review of nine studies.

Patients who participated in prehabilitation also reported better physical functioning and quality of life, indicating that exercise-based interventions can enhance overall well-being before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative Exercise Rehabilitation in Cardiac and Vascular Interventions. Drudi, LM., Tat, J., Ades, M., et al.[2020]

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Addressing Clinical Needs (the PREHAB HTx Study)

To compare the effects of a 12-week prehabilitation (PREHAB) program vs usual care (UC) on functional capacity in adults listed for heart transplantation.