Aortic Stenosis, Frailty
Conditions
Brief summary
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.
Interventions
OTHERPerioperative multi-component intervention
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%
Sponsors
Imperial College London
Barts & The London NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \> 70 years 2. Ability to provide written informed consent 3. Ability to speak English
Exclusion criteria
1. Clinical instability defined as requiring use of inotropes/mechanical-circulatory support during admission or post-cardiac arrest 2. Active delirium (4AT score ≥ 4) at time of recruitment 3. Parkinson's disease (Hoehn & Yahr stage 3-5) 4. Recent stroke (within 7 days preceding recruitment) 5. Terminal condition (e.g. metastatic cancer) with life expectancy \< 12 months 6. Clinical unsuitable for recruitment to trial according to the discretion of the research team
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility: Recruitment rates | 1 year | Average number of patients per month willing to give informed consent and be randomised into a trial of a perioperative frailty intervention |
| Feasibility: Safety | On discharge: e.g. 2-7 days | In-hospital adverse events (e.g. falls, ischaemia, arrhythmia, acute kidney injury), in-hospital mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in health-related quality of life | 30 days | Measured using EQ-5D-5L at baseline and 30 days post discharge via telephone |
| Changes in physical frailty | 30 days | 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 |
| Change in cognitive function | 30 days | Assessed using T-MoCA at admission and 30 days post discharge via telephone |
| Change in mood | 30 days | Assessed using HADS at admission and 30 days post discharge via telephone |
| Incidence of hospital-acquired disability | 30 days | defined as loss of ≥ 1 ADL at discharge compared to admission; and followed-up at 30 days after discharge |
| Length of hospital stay | On discharge: e.g. 2-7 days | Duration of inpatient stay at tertiary centre |
| Discharge destination | On discharge: e.g. 2-7 days | e.g. to patient's own home, long-term care facility or district general hospital |
| Unplanned readmissions | 30 days | Measured at 30 days post discharge from tertiary centre using hospital records and patient telephone-interview |
| Mortality | 30 days | Measured at 30 days post discharge using hospital records and NHS Spine database |
| Incidence of falls during hospitalisation | On discharge: e.g. 2-7 days | — |
| Incidence of delirium | Daily (during inpatient admission) until the seventh day post-TAVI and then twice weekly thereafter | Assessed daily during hospitalisation by using 4AT until the seventh day post-TAVI and then twice weekly thereafter |
Countries
United Kingdom
Outcome results
None listed