Clinical trial NCT04792411: Adherence and Acceptability of a Remote, Home-based, Pre-surgery Programme for Patients Undergoing Abdominal Aortic Aneurysm Surgery
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Aneurysm, Abdominal
Keywords: AAA, pre-conditioning, frailty
Lead sponsor: Imperial College Healthcare NHS Trust
Sponsor class: OTHER
Collaborators: name: Cambridge University Hospitals NHS Foundation Trust
name: Mid and South Essex NHS Foundation Trust
First posted: 2021-03-11
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

* 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

Eligibility criteria: Inclusion Criteria

* 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

Exclusion Criteria:

* Thoraco-Abdominal Aneurysms
* Connective tissue Vascular Disorder
* Symptomatic aneurysms
* Previous Aortic intervention
* Absolute contraindication to exercise
* Inability or unwillingness to participate in the trial
* Infrarenal AAA diameter exceeding 7.0cm
* Emergency AAA repair
* BMI below 20 kg/m2 or above 45 kg/m2

Primary outcomes:
measure: Feasibility of screening and recruitment
timeFrame: 18 months
measure: Feasibility of measurement tools:
timeFrame: 18 months
measure: Adherence
timeFrame: at least 6 weeks ( Duration of the programme)
measure: Acceptability of the prehabilitation programme (Patient satisfaction)
timeFrame: 18 months
Secondary outcomes:
measure: In-Hospital Complication Rate
timeFrame: Immediately after the surgery
measure: 30-day(After surgery) Composite Outcome
timeFrame: 30 days
measure: Length of stay and readmission rates (30 days post-surgery)
timeFrame: 30 days
measure: Change in 6-minute walk test (6-MWT) at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
timeFrame: 6 weeks, 3 months
measure: 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)
timeFrame: 6 weeks, 3 months
measure: Post-Operative Morbidity score (POMS)
timeFrame: Immediately after surgery
measure: Change in aneurysm specific quality of life scores at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
timeFrame: 6 weeks, 3 months
measure: Change in Hospital Anxiety and Depression Score (HADS) end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
timeFrame: 6 weeks, 3 months
measure: Change in cigarettes usage per day
timeFrame: 6 weeks, 3 months
measure: Change in weight (in kg) end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)
timeFrame: 6 weeks, 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
affiliation: Imperial College NHS Trust
name: Alun Davies
role: STUDY_CHAIR
affiliation: Cambridge University Hospitals NHS Trust
name: Tristan Lane
role: PRINCIPAL_INVESTIGATOR
affiliation: Mid and South Essex NHS Foundation Trust
name: Ankur Thapar
role: PRINCIPAL_INVESTIGATOR
References: