40 Participants Needed

Virtual PREHAB for Cardiovascular Disease

SK
Overseen ByScott Kehler, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Nova Scotia Health Authority
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of the treatment Virtual PREHAB for Cardiovascular Disease?

Research shows that prehabilitation (pre-surgery exercise and preparation) can improve physical function, reduce hospital stays, and decrease complications for heart surgery patients. Virtual PREHAB, which can be done at home, may help patients get ready for surgery by improving their health and resilience.12345

Is Virtual PREHAB for Cardiovascular Disease safe for humans?

Research on prehabilitation, including virtual programs, suggests it can improve physical and mental fitness before surgery, potentially reducing complications and improving recovery. While specific safety data for Virtual PREHAB is limited, prehabilitation in general has been shown to be beneficial and safe for patients undergoing cardiac procedures.46789

How is the Virtual PREHAB treatment different from other treatments for cardiovascular disease?

Virtual PREHAB is unique because it is a home-based, preoperative exercise program designed to improve physical function and reduce hospital stay for patients awaiting heart surgery. Unlike traditional cardiac rehabilitation, it is delivered virtually, making it more accessible and flexible for patients.26101112

What is the purpose of this trial?

Nova Scotians are aging and many are becoming frailer. People with frailty are more likely to live in worse health and do not recover well from major events, such as open heart surgery. Many people are also too frail to receive open heart surgery. Less invasive procedures called transcatheter aortic valve implantation, or TAVI, are provided for the frailest patients. While TAVI is life-saving, frailer patients are less likely to survive in better health after their operation. Patients in Nova Scotia can also wait up to 3-6 months for their operation where they become frailer or can die before receiving TAVI. The investigators believe that it is important to support these individuals to improve their frailty and overall health before their operation.Center-based cardiac rehabilitation is offered to patients after, but not before TAVI to improve their health. Center-based preoperative cardiac rehabilitation (i.e., PREHAB) can safely improve the function of frail patients who received open heart surgery. However, many patients cannot come to a center-based PREHAB because of transportation requirements to access the program. Another option is to support these patients with virtually delivered PREHAB, where they can stay in their homes. However, this possibility has not been studied.For this study, virtual PREHAB will be delivered using the virtual cardiac rehabilitation program in Nova Scotia to patients before TAVI. This intervention will be delivered by healthcare providers who routinely care for TAVI patients, including a medical director, program lead, nurse, physiotherapist, and dietician. Ther goal of this study is to determine if it is feasible and safe to use virtual PREHAB to reduce frailty before TAVI. This research fits with Research Nova Scotia's priorities to improve patient outcomes in those with significant long-term health conditions, and to provide accessible, safe, and quality virtual healthcare to patients so they can thrive after their operation.

Eligibility Criteria

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
See 2 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Virtual PREHABExperimental Treatment1 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 CareActive Control1 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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials
302
Recruited
95,300+

Findings from Research

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.
Preoperative frailty is associated with progression of postoperative cardiac rehabilitation in patients undergoing cardiovascular surgery.Arai, Y., Kimura, T., Takahashi, Y., et al.[2020]
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.
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]
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.
Preoperative Exercise Rehabilitation in Cardiac and Vascular Interventions.Drudi, LM., Tat, J., Ades, M., et al.[2020]

References

Preoperative frailty is associated with progression of postoperative cardiac rehabilitation in patients undergoing cardiovascular surgery. [2020]
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. [2022]
Preoperative Exercise Rehabilitation in Cardiac and Vascular Interventions. [2020]
Personalized teleprehabilitation in elective cardiac surgery: a study protocol of the Digital Cardiac Counselling randomized controlled trial. [2023]
Prehabilitation: The Right Medicine for Older Frail Adults Anticipating Transcatheter Aortic Valve Replacement, Coronary Artery Bypass Graft, and Other Cardiovascular Care. [2020]
Prehabilitation program for elective coronary artery bypass graft surgery patients: a pilot randomized controlled study. [2022]
Prehabilitation in elective patients undergoing cardiac surgery: a randomised control trial (THE PrEPS TRIAL) - a study protocol. [2023]
Reasons and predictors of non-participation in a personalized digital prehabilitation care trial for patients undergoing elective cardiothoracic surgery. [2023]
Prehabilitation in older patients prior to elective cardiac procedures (PRECOVERY): study protocol of a multicenter randomized controlled trial. [2023]
10.United Statespubmed.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. [2023]
Longer-Term Effects of Cardiac Telerehabilitation on Patients With Coronary Artery Disease: Systematic Review and Meta-Analysis. [2023]
12.United Statespubmed.ncbi.nlm.nih.gov
Effect of a virtual reality-enhanced exercise protocol after coronary artery bypass grafting. [2019]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security