Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04792411 |
| Other study ID # |
291828 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2021 |
| Est. completion date |
October 1, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
Imperial College Healthcare NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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.
- 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).
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
