Protein and Exercise to Reverse Frailty in OlderR Men and Women Undergoing TAVR: The PERFORM-TAVR Trial

STUDY DESIGN:

The PERFORM-TAVR trial (Protein and Exercise to Reverse Frailty in OldeR men and woMen undergoing Transcatheter Aortic Valve Replacement) is a multicenter randomized clinical trial with a parallel-group design. We will screen consecutive patients ≥70 years of age before TAVR and enroll those that have evidence of physical frailty defined as an SPPB score ≤8 or an SF36-PF score ≤55. The SPPB and SF36-PF were chosen as the main inclusion criteria and also as key endpoints based on their ease-of-use, reproducibility, responsiveness to change, and superior predictive value for mortality and patient-centered outcomes in the Frailty-AVR Study. We will randomly allocate 200 patients to receive a multi-faceted intervention consisting of home-based exercise and protein supplementation or standard-of-care lifestyle counselling.

INTERVENTION GROUP:

The multi-faceted intervention consists of two synergistic components performed by participants at their homes. The first component is a home-based supervised exercise program that combines walking and weight-bearing exercises to build strength and balance performed for 12 weeks after the patient is discharged home post-TAVR. The exercises are based on the WEBB program that was developed at the University of Sydney and validated to help therapists individually prescribe progressive exercise that is challenging but safe for older adults (http://www.webb.org.au/attachments/File/WEBB_draft_19.pdf). Starting as soon as the patient returns home post-TAVR, a trained therapist (TT; physiotherapist or certified exercise physiologist, depending on local expertise) will visit their home for 1 hour twice weekly over a 12-week period to supervise and tailor the exercises according to each individual's capability and progress, and to reinforce the goal of moderate-intensity aerobic activity such as brisk walking at least 30 minutes 5 days per week. If the patient is transferred to a convalescence or inpatient rehabilitation facility or another hospital, the TT will defer home visits until they are discharged to their home. If the patient is referred to an outpatient rehabilitation program, the TT will continue to perform home visits concurrently. The low use of center-based rehabilitation reflects well-known accessibility barriers in our Canadian healthcare environment and reaffirms the high relevance of our home-based intervention.

To monitor compliance, the TT will ask patients to note their daily exercises in their log book and wear a wrist-worn accelerometer (Garmin Vivofit 4) to record daily step counts. The accelerometer provides motivational cues such as individualized daily step count goals and gentle beeps to remind patients to move when they have been sedentary for a prolonged period during the day. We previously used the Garmin Vivofit in an elderly cardiac population as part of the Get Going Trial and found it to be "geriatric-friendly" owing to its minimalist interface, large font size, lightweight waterproof design, and year-long battery that does not necessitate charging or computer syncing. The majority of patients (including those ≥80 years) reported a high level of comprehension and satisfaction with this device. The TT will sync the patient's accelerometer devices at every home visit using a smartphone or tablet, review their step counts, and provide personalized coaching to increase daily walking.