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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06121921
Other study ID # 330818
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date December 31, 2024

Study information

Verified date February 2024
Source Barts & The London NHS Trust
Contact Max Sayers
Phone 02073777000
Email max.sayers@nhs.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 52
Est. completion date December 31, 2024
Est. primary completion date October 31, 2024
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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

Study Design


Intervention

Other:
Perioperative 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%

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Barts & The London NHS Trust Imperial College London

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 year
Primary Feasibility: Safety In-hospital adverse events (e.g. falls, ischaemia, arrhythmia, acute kidney injury), in-hospital mortality On discharge: e.g. 2-7 days
Secondary Incidence of hospital-acquired disability defined as loss of = 1 ADL at discharge compared to admission; and followed-up at 30 days after discharge 30 days
Secondary Incidence of delirium Assessed daily during hospitalisation by using 4AT until the seventh day post-TAVI and then twice weekly thereafter Daily (during inpatient admission) until the seventh day post-TAVI and then twice weekly thereafter
Secondary Changes in health-related quality of life Measured using EQ-5D-5L at baseline and 30 days post discharge via telephone 30 days
Secondary 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 30 days
Secondary 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). On discharge: e.g. 2-7 days
Secondary 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. On discharge: e.g. 2-7 days
Secondary Change in cognitive function Assessed using T-MoCA at admission and 30 days post discharge via telephone 30 days
Secondary Change in mood Assessed using HADS at admission and 30 days post discharge via telephone 30 days
Secondary Incidence of falls during hospitalisation On discharge: e.g. 2-7 days
Secondary Length of hospital stay Duration of inpatient stay at tertiary centre On discharge: e.g. 2-7 days
Secondary Discharge destination e.g. to patient's own home, long-term care facility or district general hospital On discharge: e.g. 2-7 days
Secondary Unplanned readmissions Measured at 30 days post discharge from tertiary centre using hospital records and patient telephone-interview 30 days
Secondary Mortality Measured at 30 days post discharge using hospital records and NHS Spine database 30 days
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