NCT05617196 Virtual PREHAB Study for Patients Undergoing TAVI
| NCT ID | NCT05617196 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nova Scotia Health Authority |
| Condition | Cardiovascular Diseases in Old Age |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-01-05 |
| Primary Completion | 2025-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-01-05 with a primary completion date of 2025-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * Outpatients attending the TAVI clinic at the Queen Elizabeth II Health Sciences Centre * Informed written or verbal consent Exclusion Criteria: * New York Heart Association or Canadian Cardiovascular Score of 4 * Severe functional limitations * Cognitive impairment that impacts consenting ability * Significant language barrier * No internet or telephone access that precludes virtual PREHAB participation
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05617196 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 100 Years, studying Cardiovascular Diseases in Old Age. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05617196 currently recruiting?
Yes, NCT05617196 is actively recruiting participants. Contact the research team at scott.kehler@dal.ca for enrollment information.
Where is the NCT05617196 trial being conducted?
This trial is being conducted at Halifax, Canada.
Who is sponsoring the NCT05617196 clinical trial?
NCT05617196 is sponsored by Nova Scotia Health Authority. The trial plans to enroll 40 participants.