Cardiac Disease(PREP-ACE)NCT06275100
PREhabilitation in Patients Awaiting Acute Inpatient Cardiac SurgEry
A study testing Prehabilitation in people with Cardiac Disease and Aortic Valve Disease, run by University of Hull at 1 site in United Kingdom.
Trial summary
This is a single centre, single arm pilot feasibility study to determine the feasibility and practicality of prehabilitation in acute inpatients waiting for cardiac surgery. We will be looking into participant eligibility, acceptability, recruitment rates, completion rates and barriers to implementing a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease, Aortic Valve Disease, Coronary Artery Disease
- What is being tested?
- Prehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Apr 2024to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients over the age of 18 scheduled for acute cardiac surgery in CHH will be given consideration to participate in this clinical trial.
Who cannot join
- Patients who are unable or unwilling to participate in any of the elements of prehabilitation will be excluded. These include those that have cognitive disability (including unconsciousness), cardiac or clinical instability, functional or anatomical impairment which impairs ability to participate, language barrier or patient refusal. Patients that have impending surgery within 72 hours of arrival to hospital will be excluded. Patients who are awaiting surgery in district hospitals or outside of Castle Hill Hospital will be excluded. A non-exhaustive list of exclusion criteria is included below.
- Cardiac/ clinical instability such as:
- Recurrent unstable angina/ crescendo angina
- Untreated decompensated heart failure
- Malignant arrhythmias awaiting treatment
- Resting tachycardia (HR>100 bpm)
Show all 15Show fewer
- Left ventricular outflow obstruction such as Aortic Stenosis with pre-syncopal or syncopal symptoms
- Unresolved acute pericarditis or myocarditis
- Second or third degree heart block without pacemaker
- Aortic Dissection
- Myxoma
- Functional/ anatomical impairment such as:
- Severe musculoskeletal conditions that would prohibit exercise
- Amputees
- Registered blind
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Hull University Teaching Hospital
Hull, HU1 3DR
About this study
This is a single centre, single arm pilot feasibility study to determine the feasibility and practicality of prehabilitation in acute inpatients waiting for cardiac surgery. We will be looking into participant eligibility, acceptability, recruitment rates, completion rates and barriers to implementing a prehabilitation programme. Secondary outcomes include safety (incidence of adverse events directly related to the study), improvement in 6 minutes walk test (6MWT), hand grip strength, quality of life, and spirometry. At the end of the trial, we will be seeking the feedback of the participants to help us improve the design further.
Read the detailed description
Prehabilitation is a process of preparing a patient for major surgery with the aim of improving their outcome and recovery. Prehabilitation has shown benefits such as reduced post-operative complications and shorter inpatient stay in elective cardiac surgery population. There is currently no published research looking into the benefit of prehabilitation in acute inpatients.
I am currently doing an MD focusing on inpatients waiting for acute cardiac surgery in Castle Hill Hospital (CHH). The rationale for this is based on National Institute for Cardiovascular Outcomes Research (NICOR) report indicating that acute cardiac surgery waiting times increased, ranging from 7 to 24 days. Traditionally, inpatients are asked to have bed rest. However, this affects patient's mental and physical wellbeing, and hence negatively impact outcome.
The project consist of three parts. The first is an analysis of patients who had cardiac surgery in 2022 based on cardiac surgery audit data which is routinely collected for all patients. The purpose of this study is to assess the waiting times for acute cardiac surgery in East Yorkshire and describe the demographic and potential impact of the waiting times on these patients. We have sought local governance approval for this section as it involves data that is routinely collected in the department.
The second part of the project is a survey amongst patients waiting for acute cardiac surgery to gauge patient interest, how to engage them, opinion on design and potential problems that needs to be addressed.
The third and main part of the project is a single centre, single arm, prospective, pilot feasibility trial aiming to recruit 20 acute inpatients. The primary objective of the trial is to investigate the feasibility, acceptability and completion rates of prehabilitation. The secondary objective is to identify any potential improvement and safety concerns. The intervention involves exercise and anxiety management. The interventions will start as soon as the patient is recruited, end on the day before surgery and not impact the date of their surgery.
We have received ethical approval from Hull York Medical School (HYMS) ethics committee for the second and third part of the project. In addition to this, we have also applied for Research Ethics Committee (REC) approval in Integrated Research Application System (IRAS). We are awaiting the REC approval.
- Conditions
- Cardiac Disease, Aortic Valve Disease, Coronary Artery Disease, Endocarditis, Valve Heart Disease
- Being tested
- Prehabilitation
- Medical subject headings
- Heart Diseases, Aortic Valve Disease, Coronary Artery Disease, Endocarditis, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationOther
Also called exercise, psychological
Participants will be exposed to exercise and psychoeducation. Aerobic exercise will be on a cycle ergometer tailored to their capability and will aim for a low to moderate intensity.The patients will be exercised using the intermittent protocol of alternating 1 minute moderate and 1 minute low intensity aerobic exercise. This duration can be gradually increased during subsequent sessions depending on the patient's ability. Aerobic exercise will be conducted 2- 3 times per week depending on patient's ability.
In addition, participants are expected to do strength and inspiratory muscle training in their own time.
The psychoeducation booklet and audio are designed with input from in-house clinical psychologist. The aim of the booklet is to explain the emotions they may feel whilst being in hospital, symptoms of anxiety, suggest how to manage anxiety, behavioural strategies that may help and signposting if they require further support.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation arm | Experimental | Participants will be exposed to physical and psychological prehabilitation whilst waiting for surgery. The prehabilitation will not alter the surgical waiting time or any medical intervention but aims to work around patient's essential care.
Physical/ exercise component has a directly supervised component (aerobic exercise) and an unsupervised portion (Inspiratory muscle training and strength training) which is done via an app or leaflet depending on participant's preference. Participants will be given a guide number of exercises to do in their own time throughout the day.
The psychological component consist of a psychoeducation booklet, meditation audio and signposting if they require further assistance. The psychoeducation component is voluntary. Receives: Other: Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of prehabilitation in acute inpatients waiting for cardiac surgery
We will be assessing the eligibility, recruitment rate, deliverability, logistical, practicality, completion rate, achievability and acceptability of the program. This is based on the recruitment as well as participant feedback interview.
Measured: We estimate from patient recruitment to day before surgery can be between 7 days and 4 weeks. Intervention will start as soon as patient is recruited and end the day before their surgery
Secondary outcomes (7)
Efficacy of prehabilitation
To identify a signal of efficacy for positive changes in physical health exercise, mental wellbeing and quality of life. This is done by assessing participants changes in 6 minutes walk test (6MWT).
Measured: Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery
Efficacy of prehabilitation
To identify a signal of efficacy for positive changes in physical health exercise, mental wellbeing and quality of life. This is done by assessing participants changes in hand grip strength.
Measured: Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery
Efficacy of prehabilitation
To identify a signal of efficacy for positive changes in physical health exercise, mental wellbeing and quality of life. This is done by assessing participants changes in EuroQol questionnaire (EQ5D5L).
Measured: Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery
Efficacy of prehabilitation
To identify a signal of efficacy for positive changes in physical health exercise, mental wellbeing and quality of life. This is done by assessing participants changes in Cardiac Anxiety Questionnaire (CAQ).
Measured: Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery
Efficacy of prehabilitation
To identify a signal of efficacy for positive changes in physical health exercise, mental wellbeing and quality of life. This is done by assessing participants changes in spirometry.
Measured: Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery
Complication rate
To identify differences in length of hospital stay, complications and readmission rates to hospital following surgery compared to usual care. This is done by comparing our outcomes with the hospital's standard care. Outcome from standard care will be obtained from hospital audit data
Measured: Day 0 (pre op) to day of patient discharge or 30 post op
Safety of Prehabilitation in acute inpatients waiting for surgery
Throughout the study, we will be collecting information on adverse events, complications which may or may not be related to the intervention(s)
Measured: day 0 to day before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start3 Apr 2024
- Primary completionDec 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm pilot feasibility study in acute inpatients waiting for cardiac surgery. Intervention is a prehabilitation program
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hull
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Raut, Principal investigator, University of Hull
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275100
- Sponsor's protocol ID
- HUTH
- Acronym
- (PREP-ACE)
- Status last verified
- Apr 2024
- First submitted
- 16 Oct 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No personal data will be shared. However, if requested, anonymised data pertaining to the study can be shared
Publications
Raut S, Hales A, Twiddy M, Dixon L, Ngaage D, Yates D, Danjoux G, Ingle L. Multimodal prehabilitation in people awaiting acute inpatient cardiac surgery: Study protocol for a pilot feasibility trial (PreP-ACe). PLoS One. 2025 Mar 10;20(3):e0307341. doi: 10.1371/journal.pone.0307341. eCollection 2025.
PubMed 40063583
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREhabilitation in Patients Awaiting Acute Inpatient Cardiac SurgEry
- ClinicalTrials.gov ID
- NCT06275100
- Acronym / sponsor ID
- (PREP-ACE) / HUTH
- Conditions
- Cardiac Disease, Aortic Valve Disease, Coronary Artery Disease, Endocarditis, Valve Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of HullUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 23 Feb 2024 (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 single centre, single arm pilot feasibility study to determine the feasibility and practicality of prehabilitation in acute inpatients waiting for cardiac surgery. We will be looking into participant eligibility, acceptability, recruitment rates, completion rates and barriers to implementing a prehabilitation programme. Secondary outcomes include safety (incidence of adverse events directly related to the study), improvement in 6 minutes walk test (6MWT), hand grip strength, quality of life, and spirometry. At the end of the trial, we will be seeking the feedback of the participants to help us improve the design further.
Detailed description
Prehabilitation is a process of preparing a patient for major surgery with the aim of improving their outcome and recovery. Prehabilitation has shown benefits such as reduced post-operative complications and shorter inpatient stay in elective cardiac surgery population. There is currently no published research looking into the benefit of prehabilitation in acute inpatients.
I am currently doing an MD focusing on inpatients waiting for acute cardiac surgery in Castle Hill Hospital (CHH). The rationale for this is based on National Institute for Cardiovascular Outcomes Research (NICOR) report indicating that acute cardiac surgery waiting times increased, ranging from 7 to 24 days. Traditionally, inpatients are asked to have bed rest. However, this affects patient's mental and physical wellbeing, and hence negatively impact outcome.
The project consist of three parts. The first is an analysis of patients who had cardiac surgery in 2022 based on cardiac surgery audit data which is routinely collected for all patients. The purpose of this study is to assess the waiting times for acute cardiac surgery in East Yorkshire and describe the demographic and potential impact of the waiting times on these patients. We have sought local governance approval for this section as it involves data that is routinely collected in the department.
The second part of the project is a survey amongst patients waiting for acute cardiac surgery to gauge patient interest, how to engage them, opinion on design and potential problems that needs to be addressed.
The third and main part of the project is a single centre, single arm, prospective, pilot feasibility trial aiming to recruit 20 acute inpatients. The primary objective of the trial is to investigate the feasibility, acceptability and completion rates of prehabilitation. The secondary objective is to identify any potential improvement and safety concerns. The intervention involves exercise and anxiety management. The interventions will start as soon as the patient is recruited, end on the day before surgery and not impact the date of their surgery.
We have received ethical approval from Hull York Medical School (HYMS) ethics committee for the second and third part of the project. In addition to this, we have also applied for Research Ethics Committee (REC) approval in Integrated Research Application System (IRAS). We are awaiting the REC approval.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm pilot feasibility study in acute inpatients waiting for cardiac surgery. Intervention is a prehabilitation program
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation arm | Experimental | Other: PrehabilitationParticipants will be exposed to physical and psychological prehabilitation whilst waiting for surgery. The prehabilitation will not alter the surgical waiting time or any medical intervention but aims to work around patient's essential care. Physical/ exercise component has a directly supervised component (aerobic exercise) and an unsupervised portion (Inspiratory muscle training and strength training) which is done via an app or leaflet depending on participant's preference. Participants will be given a guide number of exercises to do in their own time throughout the day. The psychological component consist of a psychoeducation booklet, meditation audio and signposting if they require further assistance. The psychoeducation component is voluntary. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients over the age of 18 scheduled for acute cardiac surgery in CHH will be given consideration to participate in this clinical trial.
Key exclusion criteria (15 listed)
- Patients who are unable or unwilling to participate in any of the elements of prehabilitation will be excluded. These include those that have cognitive disability (including unconsciousness), cardiac or clinical instability, functional or anatomical impairment which impairs ability to participate, language barrier or patient refusal. Patients that have impending surgery within 72 hours of arrival to hospital will be excluded. Patients who are awaiting surgery in district hospitals or outside of Castle Hill Hospital will be excluded. A non-exhaustive list of exclusion criteria is included below.
- Recurrent unstable angina/ crescendo angina
- Untreated decompensated heart failure
- Malignant arrhythmias awaiting treatment
- Resting tachycardia (HR>100 bpm)
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 |
|---|---|---|
| PrehabilitationAlso: exercise, psychologicalParticipants will be exposed to exercise and psychoeducation. Aerobic exercise will be on a cycle ergometer tailored to their capability and will aim for a low to moderate intensity.The patients will be exercised using the intermittent protocol of alternating 1 minute moderate and 1 minute low intensity aerobic exercise. This duration can be gradually increased during subsequent sessions depending on the patient's ability. Aerobic exercise will be conducted 2- 3 times per week depending on patient's ability. In addition, participants are expected to do strength and inspiratory muscle training in their own time. The psychoeducation booklet and audio are designed with input from in-house clinical psychologist. The aim of the booklet is to explain the emotions they may feel whilst being in hospital, symptoms of anxiety, suggest how to manage anxiety, behavioural strategies that may help and signposting if they require further support. | Other | Prehabilitation arm |
Primary outcome
Feasibility of prehabilitation in acute inpatients waiting for cardiac surgery
Time frame: We estimate from patient recruitment to day before surgery can be between 7 days and 4 weeks. Intervention will start as soon as patient is recruited and end the day before their surgery
We will be assessing the eligibility, recruitment rate, deliverability, logistical, practicality, completion rate, achievability and acceptability of the program. This is based on the recruitment as well as participant feedback interview.
7 secondary outcomes
Efficacy of prehabilitation
Time frame: Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery
Efficacy of prehabilitation
Time frame: Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery
Efficacy of prehabilitation
Time frame: Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery
Efficacy of prehabilitation
Time frame: Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery
Efficacy of prehabilitation
Time frame: Assessment will be done on day 0 (recruitment), day 7 and day 14 or day before surgery
Complication rate
Time frame: Day 0 (pre op) to day of patient discharge or 30 post op
Safety of Prehabilitation in acute inpatients waiting for surgery
Time frame: day 0 to day before surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Derived from this study: PubMed 40063583Raut S, Hales A, Twiddy M, Dixon L, Ngaage D, Yates D, Danjoux G, Ingle L. Multimodal prehabilitation in people awaiting acute inpatient cardiac surgery: Study protocol for a pilot feasibility trial (PreP-ACe). PLoS One. 2025 Mar 10;20(3):e0307341. doi: 10.1371/journal.pone.0307341. eCollection 2025.
- Individual participant dataSharing planned: No. No personal data will be shared. However, if requested, anonymised data pertaining to the study can be shared
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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.
Sarah Raut principal investigator
University of Hull
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation in people with Cardiac Disease and Aortic Valve Disease, run by University of Hull 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 1 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 9 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Raut (01482624096, sarah.raut@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of prehabilitation in acute inpatients waiting for cardiac surgery (time frame: We estimate from patient recruitment to day before surgery can be between 7 days and 4 weeks. Intervention will start as soon as patient is recruited and end the day before their surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06275100, which also lists 1 linked publication.
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 9 Apr 2024.