Clinical trial NCT05617196: Virtual PREHAB Study for Patients Undergoing TAVI
Official title: Feasibility of a Virtually Delivered Preoperative Rehabilitation Program for Patients Awaiting TAVI to Reduce Frailty: The Virtual PREHAB Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases in Old Age
Frailty
TAVI
Keywords: Frailty
Virtual PREHAB
Cardiac rehabilitation
TAVI
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2022-11-15
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: CLSA-FI
timeFrame: Baseline
measure: CLSA-FI
timeFrame: 8-weeks preoperatively
measure: CLSA-FI
timeFrame: 1-week preoperatively
measure: CLSA-FI
timeFrame: 3-months postoperatively
measure: PFFS-FI
timeFrame: Baseline
measure: PFFS-FI
timeFrame: 1-week preoperatively
measure: PFFS-FI
timeFrame: 8-weeks preoperatively
measure: PFFS-FI
timeFrame: 3-months postoperatively
Secondary outcomes:
measure: EQ-5D-5L health-related quality of life
timeFrame: Baseline
measure: EQ-5D-5L health-related quality of life
timeFrame: 8-weeks preoperatively
measure: EQ-5D-5L health-related quality of life
timeFrame: 1-week preoperatively
measure: EQ-5D-5L health-related quality of life
timeFrame: 3-months postoperatively
measure: VARC-3 Composite clinical end-points
timeFrame: Hospital discharge (assessed up to day 14)
measure: VARC-3 Composite clinical end-points
timeFrame: 30-days postoperatively
measure: Cardiac rehabilitation attendance
timeFrame: 3-months postoperatively
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health
state: Nova Scotia
Study officials:
References: