FrailtyNCT06121921
RESTORE-TAVI Pilot
A study testing Perioperative multi-component intervention in people with Frailty and Aortic Stenosis, run by Barts & The London NHS Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frailty, Aortic Stenosis
- What is being tested?
- Perioperative multi-component intervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jun 2024to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age > 70 years
- Ability to provide written informed consent
- Ability to speak English
Who cannot join
- Clinical instability defined as requiring use of inotropes/mechanical-circulatory support during admission or post-cardiac arrest
- Active delirium (4AT score ≥ 4) at time of recruitment
- Parkinson's disease (Hoehn \& Yahr stage 3-5)
- Recent stroke (within 7 days preceding recruitment)
- Terminal condition (e.g. metastatic cancer) with life expectancy < 12 months
- Clinical unsuitable for recruitment to trial according to the discretion of the research team
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
- Conditions
- Frailty, Aortic Stenosis
- Being tested
- Perioperative multi-component intervention
- Medical subject headings
- Frailty, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative multi-component interventionOther
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%
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Perioperative multi-component intervention Receives: Other: Perioperative multi-component intervention |
| Control | No intervention | Routine inpatient care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Feasibility: Safety
In-hospital adverse events (e.g. falls, ischaemia, arrhythmia, acute kidney injury), in-hospital mortality
Measured: On discharge: e.g. 2-7 days
Secondary outcomes (13)
Incidence of hospital-acquired disability
defined as loss of ≥ 1 ADL at discharge compared to admission; and followed-up at 30 days after discharge
Measured: 30 days
Incidence of delirium
Assessed daily during hospitalisation by using 4AT until the seventh day post-TAVI and then twice weekly thereafter
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: On discharge: e.g. 2-7 days
Change in cognitive function
Assessed using T-MoCA at admission and 30 days post discharge via telephone
Measured: 30 days
Change in mood
Assessed using HADS at admission and 30 days post discharge via telephone
Measured: 30 days
Incidence of falls during hospitalisation
Measured: On discharge: e.g. 2-7 days
Length of hospital stay
Duration of inpatient stay at tertiary centre
Measured: On discharge: e.g. 2-7 days
Discharge destination
e.g. to patient's own home, long-term care facility or district general hospital
Measured: 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
Measured: 30 days
Mortality
Measured at 30 days post discharge using hospital records and NHS Spine database
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start7 Jun 2024
- Primary completion1 May 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College London
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06121921
- Sponsor's protocol ID
- 330818
- Status last verified
- May 2025
- First submitted
- 16 Oct 2023
- Last updated
- 23 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06121921
- Acronym / sponsor ID
- 330818
- Conditions
- Frailty, Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Imperial College London
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Perioperative multi-component interventionPerioperative multi-component intervention |
| Control | No intervention | –Routine inpatient care |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age > 70 years
- Ability to provide written informed consent
- Ability to speak English
Key exclusion criteria (6 listed)
- Clinical instability defined as requiring use of inotropes/mechanical-circulatory support during admission or post-cardiac arrest
- Active delirium (4AT score ≥ 4) at time of recruitment
- Parkinson's disease (Hoehn \& Yahr stage 3-5)
- Recent stroke (within 7 days preceding recruitment)
- Terminal condition (e.g. metastatic cancer) with life expectancy < 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perioperative multi-component interventionPhysical 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% | Other | Intervention |
Primary outcome
Feasibility: Recruitment rates
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
Feasibility: Safety
Time frame: On discharge: e.g. 2-7 days
In-hospital adverse events (e.g. falls, ischaemia, arrhythmia, acute kidney injury), in-hospital mortality
13 secondary outcomes
Incidence of hospital-acquired disability
Time frame: 30 days
Incidence of delirium
Time frame: Daily (during inpatient admission) until the seventh day post-TAVI and then twice weekly thereafter
Changes in health-related quality of life
Time frame: 30 days
Changes in physical frailty
Time frame: 30 days
Changes in physical frailty
Time frame: On discharge: e.g. 2-7 days
Changes in physical frailty
Time frame: On discharge: e.g. 2-7 days
Change in cognitive function
Time frame: 30 days
Change in mood
Time frame: 30 days
Incidence of falls during hospitalisation
Time frame: On discharge: e.g. 2-7 days
Length of hospital stay
Time frame: On discharge: e.g. 2-7 days
Discharge destination
Time frame: On discharge: e.g. 2-7 days
Unplanned readmissions
Time frame: 30 days
Mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perioperative multi-component intervention in people with Frailty and Aortic Stenosis, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Recruitment rates (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.