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| Name | Class |
|---|---|
| Cambridge University Hospitals NHS Foundation Trust | OTHER |
| Mid and South Essex NHS Foundation Trust | OTHER |
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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.
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).
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prehabilitation group | Experimental | This arm will be subject to at least 6 weeks of a tailored prehabilitation programme |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prehabilitation | Behavioral | Multimodal, tailored prehabilitation programme |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 18 months |
| Adherence | Number of sessions attended The proportion of participants who complete' the 6-week programme | 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. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| In-Hospital Complication Rate | - Composite of Cardiac, Respiratory, Renal, Haemorrhage, Limb Ischaemia and Cerebral Complications, as defined by National Vascular Registry | Immediately after the surgery |
| 30-day(After surgery) Composite Outcome |
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Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alun Davies | Imperial College NHS Trust | Study Chair |
| Tristan Lane | Cambridge University Hospitals NHS Foundation Trust | Principal Investigator |
| Ankur Thapar | Mid and South Essex NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College London | London | W68RF | United Kingdom |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000082622 | Preoperative Exercise |
| ID | Term |
|---|---|
| D019990 | Perioperative Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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Incidence of Mortality Incidence of complications
| 30 days |
| Length of stay and readmission rates (30 days post-surgery) | Reintervention, or areadmission related to repair or other complications | 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 | 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 | 6 weeks, 3 months |
| Post-Operative Morbidity score (POMS) | To measure post operative complications and it's impact on participants | 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 | 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) | 6 weeks, 3 months |
| Change in cigarettes usage per day | Difference in cigarettes usage at different phases of the study | 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 | 6 weeks, 3 months |
| D001018 |
| Aortic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015444 |
| Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |