This is a pilot randomised control study assessing the feasibility and effectiveness of a perioperative multi-component intervention aimed at reducing adverse hospital events and improving functional outcomes in patients with acute decompensated aortic stenosis undergoing urgent transcatheter aortic valve implantation compared to standard care. The intervention will consist of physical rehabilitation, delirium prevention, nutritional supplementation and anaemia correction (where indicated). The primary objective is to determine the feasibility and safety of delivering this intervention Secondary objectives include investigating the impact on adverse hospital events such as hospital-acquired disability and post-TAVI delirium, and on health-related quality of life and functional recovery following TAVI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
40
Physical Component Self-directed daily non-ambulatory exercise programme, comprising: * Rubber ball squeezes (3 sets of 12 reps, per hand) * Bicep curls (3 sets of 12 reps) * Leg extensions (3 sets of 12 reps) * Chair rises (3 sets of 12 reps) * Arm stretches (3 sets of 3 reps) Additional encouragement to mobilise Cognitive Component: Delirium prevention strategies including orientation, hydration, bowel/bladder function, infection control, analgesia, polypharmacy and cognitive stimulation Nutritional Component: * Formal dietician review if MUST score ≥ 2 * IV ferritin if LVEF \<45% and serum ferritin \<100ng/mL or ferritin 100-299ng/mL with TSAT \<20%
Barts and the London NHS Trust
London, United Kingdom
Feasibility: Recruitment rates
Average number of patients per month willing to give informed consent and be randomised into a trial of a perioperative frailty intervention
Time frame: 1 year
Feasibility: Safety
In-hospital adverse events (e.g. falls, ischaemia, arrhythmia, acute kidney injury), in-hospital mortality
Time frame: On discharge: e.g. 2-7 days
Incidence of hospital-acquired disability
defined as loss of ≥ 1 ADL at discharge compared to admission; and followed-up at 30 days after discharge
Time frame: 30 days
Incidence of delirium
Assessed daily during hospitalisation by using 4AT until the seventh day post-TAVI and then twice weekly thereafter
Time frame: Daily (during inpatient admission) until the seventh day post-TAVI and then twice weekly thereafter
Changes in health-related quality of life
Measured using EQ-5D-5L at baseline and 30 days post discharge via telephone
Time frame: 30 days
Changes in physical frailty
By comparing SARC-F (strength, assistance with walking, rise form a chair, climb stairs and falls) questionnaire at baseline and 30 days (via telephone) after discharge
Time frame: 30 days
Changes in physical frailty
By comparing dominant handgrip strength at admission and discharge - average of 3 trials of maximal isometric grip measured in kilograms using a Jamar hydraulic hand dynamometer (Anatomy Supply Partners LLC, Georgia, USA).
Time frame: On discharge: e.g. 2-7 days
Changes in physical frailty
By comparing timed chair rises at admission and discharge - time (measures in seconds) to complete five chair rises without using arms.
Time frame: On discharge: e.g. 2-7 days
Change in cognitive function
Assessed using T-MoCA at admission and 30 days post discharge via telephone
Time frame: 30 days
Change in mood
Assessed using HADS at admission and 30 days post discharge via telephone
Time frame: 30 days
Incidence of falls during hospitalisation
Time frame: On discharge: e.g. 2-7 days
Length of hospital stay
Duration of inpatient stay at tertiary centre
Time frame: On discharge: e.g. 2-7 days
Discharge destination
e.g. to patient's own home, long-term care facility or district general hospital
Time frame: On discharge: e.g. 2-7 days
Unplanned readmissions
Measured at 30 days post discharge from tertiary centre using hospital records and patient telephone-interview
Time frame: 30 days
Mortality
Measured at 30 days post discharge using hospital records and NHS Spine database
Time frame: 30 days
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