Barts and the London NHS Trust
London, EC1A 7BE, United Kingdom
NCT Number: NCT06121921
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.
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Notify Me70 year and older
All sexes
Interventional
Not applicable
London, EC1A 7BE, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Physical Component
Self-directed daily non-ambulatory exercise programme, comprising:
Cognitive Component:
Delirium prevention strategies including orientation, hydration, bowel/bladder function, infection control, analgesia, polypharmacy and cognitive stimulation
Nutritional Component:
Time frame: 1 year
Average number of patients per month willing to give informed consent and be randomised into a trial of a perioperative frailty intervention
Time frame: On discharge: e.g. 2-7 days
In-hospital adverse events (e.g. falls, ischaemia, arrhythmia, acute kidney injury), in-hospital mortality
Time frame: 30 days
defined as loss of ≥ 1 ADL at discharge compared to admission; and followed-up at 30 days after discharge
Time frame: 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
Time frame: 30 days
Measured using EQ-5D-5L at baseline and 30 days post discharge via telephone
Time frame: 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
Time frame: On discharge: e.g. 2-7 days
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
By comparing timed chair rises at admission and discharge - time (measures in seconds) to complete five chair rises without using arms.
Time frame: 30 days
Assessed using T-MoCA at admission and 30 days post discharge via telephone
Time frame: 30 days
Assessed using HADS at admission and 30 days post discharge via telephone
Time frame: On discharge: e.g. 2-7 days
Time frame: On discharge: e.g. 2-7 days
Duration of inpatient stay at tertiary centre
Time frame: On discharge: e.g. 2-7 days
e.g. to patient's own home, long-term care facility or district general hospital
Time frame: 30 days
Measured at 30 days post discharge from tertiary centre using hospital records and patient telephone-interview
Time frame: 30 days
Measured at 30 days post discharge using hospital records and NHS Spine database
Barts & The London NHS Trust
Other
A Pilot Study Assessing the Feasibility and Effectiveness of a Perioperative Multi-component Intervention in Patients With Acute Decompensated Aortic Stenosis Undergoing Urgent Transcatheter Aortic Valve Intervention
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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