Aortic Aneurysm, AbdominalNCT04792411
Adherence and Acceptability of a Remote, Home-based, Pre-surgery Programme for Patients Undergoing Abdominal Aortic Aneurysm Surgery
A study testing Prehabilitation in people with Aortic Aneurysm, Abdominal, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
Design A multi-centre pilot study investigating the acceptability and adherence of a prehabilitation on patients requiring abdominal aortic aneurysm repair. Setting 3 NHS Hospital Vascular Surgery Clinics in the UK. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aortic Aneurysm, Abdominal
- What is being tested?
- Prehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2021to 1 Oct 2023
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (aged 55 years and over) who have been diagnosed with an AAA and are scheduled to undergo EVAR or open surgery (with a wait time of at least 6-weeks for surgery).
- Patients with an AAA with a diameter of 5.5cm to 7cm
- Able to write, understand and communicate in English
- Willing and able to participate in a virtual prehabilitation programme
Who cannot join
- Thoraco-Abdominal Aneurysms
- Connective tissue Vascular Disorder
- Symptomatic aneurysms
- Previous Aortic intervention
- Absolute contraindication to exercise
- Inability or unwillingness to participate in the trial
Show all 9Show fewer
- Infrarenal AAA diameter exceeding 7.0cm
- Emergency AAA repair
- BMI below 20 kg/m2 or above 45 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-centre, Pilot Study Evaluating the Feasibility, Acceptability, and Short-term Outcomes of a Tailored, Virtual, Home-based, Multicomponent Prehabilitation Programme in Patients Undergoing Abdominal Aortic Aneurysms (AAA) Repair.
Design A multi-centre pilot study investigating the acceptability and adherence of a prehabilitation on patients requiring abdominal aortic aneurysm repair.
Setting 3 NHS Hospital Vascular Surgery Clinics in the UK.
Read more
- Imperial College Healthcare NHS Trust
- Cambridge University Hospitals NHS Trust
- Mid and South Essex NHS Trust
Patient Population Patients referred to secondary/tertiary vascular clinic for the repair of asymptomatic infrarenal Aneurysm
Intervention:
Baseline (conducted face-to-face): After providing written informed consent, participants will be provided with information about the prehabilitation programme. The following data will also be collected: baseline demographic characteristics (including age, sex and ethnicity), body mass index (BMI), medical history (including time since diagnosis), current medication, aneurysm diameter, health-related quality of life (EQ-5D-5L and EQ-VAS), smoking status and psychological wellbeing (using the Hospital Anxiety and Depression Scale; HADS) and Frailty assessments( QMortality Index, Electronic Frailty Index, Rockall score). Participants will also complete a 6-minute walking test(6MWT).
Read the detailed description
Weeks 1 to 5 (conducted remotely via telephone, email or completion of an online survey):
The programme has been developed with experts in the field of sports therapy, physiotherapy and biomechanics, based on robust literature in other fields. The course plan is to start with 3 sessions every week for 6 weeks where participants would complete a tailored home exercise programme or until the expected surgical intervention. In the first week of this programme, the patient will receive three sessions with a total of 150 minutes of exercise according to UK Chief Medical Officers' Physical Activity Guidelines. After each week, we will assess patient tolerance to the exercise regime using Borg scale. The researchers will either increase or decrease exercise intensity according to their feedback. The study will also be assessing patients' preference for how and when they would like to exercise.
End of Programme (conducted remotely via telephone, email or completion of an online survey):
Participants will be contacted by a member of the study team for the reassessment of health-related quality of life, psychological wellbeing and smoking status. Participants will also be required to provide their self-reported weight. On admission for surgery, they will be assessed for frailty using frailty score assessments
Post - Operative Morbidity score(POMS) will be assessed during admission ( Day1, Day 3, Day 5, Day 7, etc) after surgery.
Discharge: (conducted either remotely or face to face):
Participants will complete a reassessment of health-related quality of life, disease-specific quality of life, psychological wellbeing and smoking status. Participants will also complete the 6-MWT.
6 weeks post-surgery (conducted remotely or face-to-face): Participants will complete a reassessment of health-related quality of life, disease-specific quality of life, psychological wellbeing and smoking status. Participants will also complete the 6-MWT.
90-days post-surgery (conducted remotely or face-to-face): Participants will complete reassessment of health-related quality of life, disease-specific quality of life, psychological wellbeing and smoking status. Participants will also complete the 6-MWT. Participants will also complete a frailty assessment score (Rockall)
Treatments Standard national and local practice will be followed for the repair of infra-renal aortic aneurysm. Patients will receive any type of repair as decided by the local Vascular Multi-Disciplinary Team.
Primary Outcome Prehabilitation Programme compliance, attendance and acceptability.
Secondary Outcomes
- In-Hospital Complication Rate - Composite of Cardiac, Respiratory, Renal, Haemorrhage, Limb Ischaemia and Cerebral Complications, as defined by National Vascular Registry
- Length of stay and readmission rates (30 days post-surgery)
- 30-day Composite Outcome: Death and Defined complication (Cardiac, respiratory, haemorrhage, limb ischaemia, renal failure)
- Change in 6-minute walk test (6-MWT) at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
- Change in health-related quality of life scores (using the EuroQol five-dimensional questionnaire [EQ-5D] and visual analogue scale [EQ-VAS]) at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
- Post-Operative Morbidity score (POMS)
- Change in aneurysm specific quality of life scores at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
- Change in Hospital Anxiety and Depression Score (HADS) at 6-weeks post enrolment and 30 and 90-days post-surgery
- Reduction in cigarettes per day at 6-weeks post enrolment and 30 and 90-days post-surgery
- Change in weight (in kg) 6-weeks post enrolment and 30 and 90-days post-surgery
- Conditions
- Aortic Aneurysm, Abdominal
- Being tested
- Prehabilitation
- Keywords
- AAA, pre-conditioning, frailty
- Medical subject headings
- Aortic Aneurysm, Abdominal, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrehabilitationBehavioural
Multimodal, tailored prehabilitation programme
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation group | Experimental | This arm will be subject to at least 6 weeks of a tailored prehabilitation programme Receives: Behavioral: Prehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of screening and recruitment
The number of participants referred at each site will be captured The number of participants eligible for screening at each site will be captured The number of participants enrolled at each site will be captured Reasons for non-participation will be captured
Measured: 18 months
Feasibility of measurement tools:
Time taken to complete the questionnaires at each time-point The ratio of missing data from questionnaires Follow-up response rates
Measured: 18 months
Adherence
Number of sessions attended The proportion of participants who complete' the 6-week programme
Measured: at least 6 weeks ( Duration of the programme)
Acceptability of the prehabilitation programme (Patient satisfaction)
Patient satisfaction will be measured using questionnaires Reasons for drop-out will be captured.
Measured: 18 months
Secondary outcomes (10)
In-Hospital Complication Rate
- Composite of Cardiac, Respiratory, Renal, Haemorrhage, Limb Ischaemia and Cerebral Complications, as defined by National Vascular Registry
Measured: Immediately after the surgery
30-day(After surgery) Composite Outcome
Incidence of Mortality Incidence of complications
Measured: 30 days
Length of stay and readmission rates (30 days post-surgery)
Reintervention, or areadmission related to repair or other complications
Measured: 30 days
Change in 6-minute walk test (6-MWT) at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
To measure the change of patient physical function
Measured: 6 weeks, 3 months
Change in health-related quality of life scores (using the EuroQol five-dimensional questionnaire [EQ-5D] and visual analogue scale [EQ-VAS]) at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
Participants quality of life measure throughout the study
Measured: 6 weeks, 3 months
Post-Operative Morbidity score (POMS)
To measure post operative complications and it's impact on participants
Measured: Immediately after surgery
Change in aneurysm specific quality of life scores at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
Participants quality of life measure related to aneurysm repair throughout the study
Measured: 6 weeks, 3 months
Change in Hospital Anxiety and Depression Score (HADS) end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
Participants anxiety and depression score change throughout the study 0-7 (Normal) 8-10 (Mild) 11-15 (Moderate) 16-21 (Severe)
Measured: 6 weeks, 3 months
Change in cigarettes usage per day
Difference in cigarettes usage at different phases of the study
Measured: 6 weeks, 3 months
Change in weight (in kg) end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
Measure weight change
Measured: 6 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 Sep 2021
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm, AbdominalStudies 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, Mid and South Essex NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Alun Davies, Study chair, Imperial College NHS TrustTristan Lane, Principal investigator, Cambridge University Hospitals NHS Foundation TrustAnkur Thapar, Principal investigator, Mid and South Essex NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792411
- Sponsor's protocol ID
- 291828
- Status last verified
- Oct 2023
- First submitted
- 4 Mar 2021
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- 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 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-centre, Pilot Study Evaluating the Feasibility, Acceptability, and Short-term Outcomes of a Tailored, Virtual, Home-based, Multicomponent Prehabilitation Programme in Patients Undergoing Abdominal Aortic Aneurysms (AAA) Repair.
- ClinicalTrials.gov ID
- NCT04792411
- Acronym / sponsor ID
- 291828
- Conditions
- Aortic Aneurysm, Abdominal
- Keywords
- AAA, pre-conditioning, frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Cambridge University Hospitals NHS Foundation Trust, Mid and South Essex NHS Foundation Trust
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 11 Mar 2021 (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.
Design A multi-centre pilot study investigating the acceptability and adherence of a prehabilitation on patients requiring abdominal aortic aneurysm repair.
Setting 3 NHS Hospital Vascular Surgery Clinics in the UK.
- Imperial College Healthcare NHS Trust
- Cambridge University Hospitals NHS Trust
- Mid and South Essex NHS Trust
Patient Population Patients referred to secondary/tertiary vascular clinic for the repair of asymptomatic infrarenal Aneurysm
Intervention:
Baseline (conducted face-to-face): After providing written informed consent, participants will be provided with information about the prehabilitation programme. The following data will also be collected: baseline demographic characteristics (including age, sex and ethnicity), body mass index (BMI), medical history (including time since diagnosis), current medication, aneurysm diameter, health-related quality of life (EQ-5D-5L and EQ-VAS), smoking status and psychological wellbeing (using the Hospital Anxiety and Depression Scale; HADS) and Frailty assessments( QMortality Index, Electronic Frailty Index, Rockall score). Participants will also complete a 6-minute walking test(6MWT).
Detailed description
Weeks 1 to 5 (conducted remotely via telephone, email or completion of an online survey):
The programme has been developed with experts in the field of sports therapy, physiotherapy and biomechanics, based on robust literature in other fields. The course plan is to start with 3 sessions every week for 6 weeks where participants would complete a tailored home exercise programme or until the expected surgical intervention. In the first week of this programme, the patient will receive three sessions with a total of 150 minutes of exercise according to UK Chief Medical Officers' Physical Activity Guidelines. After each week, we will assess patient tolerance to the exercise regime using Borg scale. The researchers will either increase or decrease exercise intensity according to their feedback. The study will also be assessing patients' preference for how and when they would like to exercise.
End of Programme (conducted remotely via telephone, email or completion of an online survey):
Participants will be contacted by a member of the study team for the reassessment of health-related quality of life, psychological wellbeing and smoking status. Participants will also be required to provide their self-reported weight. On admission for surgery, they will be assessed for frailty using frailty score assessments
Post - Operative Morbidity score(POMS) will be assessed during admission ( Day1, Day 3, Day 5, Day 7, etc) after surgery.
Discharge: (conducted either remotely or face to face):
Participants will complete a reassessment of health-related quality of life, disease-specific quality of life, psychological wellbeing and smoking status. Participants will also complete the 6-MWT.
6 weeks post-surgery (conducted remotely or face-to-face): Participants will complete a reassessment of health-related quality of life, disease-specific quality of life, psychological wellbeing and smoking status. Participants will also complete the 6-MWT.
90-days post-surgery (conducted remotely or face-to-face): Participants will complete reassessment of health-related quality of life, disease-specific quality of life, psychological wellbeing and smoking status. Participants will also complete the 6-MWT. Participants will also complete a frailty assessment score (Rockall)
Treatments Standard national and local practice will be followed for the repair of infra-renal aortic aneurysm. Patients will receive any type of repair as decided by the local Vascular Multi-Disciplinary Team.
Primary Outcome Prehabilitation Programme compliance, attendance and acceptability.
Secondary Outcomes
- In-Hospital Complication Rate - Composite of Cardiac, Respiratory, Renal, Haemorrhage, Limb Ischaemia and Cerebral Complications, as defined by National Vascular Registry
- Length of stay and readmission rates (30 days post-surgery)
- 30-day Composite Outcome: Death and Defined complication (Cardiac, respiratory, haemorrhage, limb ischaemia, renal failure)
- Change in 6-minute walk test (6-MWT) at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
- Change in health-related quality of life scores (using the EuroQol five-dimensional questionnaire [EQ-5D] and visual analogue scale [EQ-VAS]) at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
- Post-Operative Morbidity score (POMS)
- Change in aneurysm specific quality of life scores at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
- Change in Hospital Anxiety and Depression Score (HADS) at 6-weeks post enrolment and 30 and 90-days post-surgery
- Reduction in cigarettes per day at 6-weeks post enrolment and 30 and 90-days post-surgery
- Change in weight (in kg) 6-weeks post enrolment and 30 and 90-days post-surgery
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation group | Experimental | Behavioral: PrehabilitationThis arm will be subject to at least 6 weeks of a tailored prehabilitation programme |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (aged 55 years and over) who have been diagnosed with an AAA and are scheduled to undergo EVAR or open surgery (with a wait time of at least 6-weeks for surgery).
- Patients with an AAA with a diameter of 5.5cm to 7cm
- Able to write, understand and communicate in English
- Willing and able to participate in a virtual prehabilitation programme
Key exclusion criteria (9 listed)
- Thoraco-Abdominal Aneurysms
- Connective tissue Vascular Disorder
- Symptomatic aneurysms
- Previous Aortic intervention
- Absolute contraindication to exercise
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 |
|---|---|---|
| PrehabilitationMultimodal, tailored prehabilitation programme | Behavioural | Prehabilitation group |
Primary outcome
Feasibility of screening and recruitment
Time frame: 18 months
The number of participants referred at each site will be captured The number of participants eligible for screening at each site will be captured The number of participants enrolled at each site will be captured Reasons for non-participation will be captured
Feasibility of measurement tools:
Time frame: 18 months
Time taken to complete the questionnaires at each time-point The ratio of missing data from questionnaires Follow-up response rates
Adherence
Time frame: at least 6 weeks ( Duration of the programme)
Number of sessions attended The proportion of participants who complete' the 6-week programme
Acceptability of the prehabilitation programme (Patient satisfaction)
Time frame: 18 months
Patient satisfaction will be measured using questionnaires Reasons for drop-out will be captured.
10 secondary outcomes
In-Hospital Complication Rate
Time frame: Immediately after the surgery
30-day(After surgery) Composite Outcome
Time frame: 30 days
Length of stay and readmission rates (30 days post-surgery)
Time frame: 30 days
Change in 6-minute walk test (6-MWT) at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
Time frame: 6 weeks, 3 months
Change in health-related quality of life scores (using the EuroQol five-dimensional questionnaire [EQ-5D] and visual analogue scale [EQ-VAS]) at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
Time frame: 6 weeks, 3 months
Post-Operative Morbidity score (POMS)
Time frame: Immediately after surgery
Change in aneurysm specific quality of life scores at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
Time frame: 6 weeks, 3 months
Change in Hospital Anxiety and Depression Score (HADS) end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
Time frame: 6 weeks, 3 months
Change in cigarettes usage per day
Time frame: 6 weeks, 3 months
Change in weight (in kg) end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
Time frame: 6 weeks, 3 months
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 30 Oct 2023.
- 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.
Alun Davies study chair
Imperial College NHS Trust
Tristan Lane principal investigator
Cambridge University Hospitals NHS Foundation Trust
Ankur Thapar principal investigator
Mid and South Essex NHS Foundation Trust
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 Aortic Aneurysm, Abdominal, run by Imperial College Healthcare 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 4 inclusion and 9 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 30 Oct 2023. 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 of screening and recruitment (time frame: 18 months). The study lists 4 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 30 Oct 2023.