Imperial College London
London, W68RF, United Kingdom
NCT Number: NCT04792411
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).
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Notify Me55 year and older
All sexes
Interventional
Not applicable
London, W68RF, United Kingdom
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Multimodal, tailored prehabilitation programme
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
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
Time frame: at least 6 weeks ( Duration of the programme)
Number of sessions attended The proportion of participants who complete' the 6-week programme
Time frame: 18 months
Patient satisfaction will be measured using questionnaires Reasons for drop-out will be captured.
Time frame: Immediately after the surgery
Time frame: 30 days
Incidence of Mortality Incidence of complications
Time frame: 30 days
Reintervention, or areadmission related to repair or other complications
Time frame: 6 weeks, 3 months
To measure the change of patient physical function
Time frame: 6 weeks, 3 months
Participants quality of life measure throughout the study
Time frame: Immediately after surgery
To measure post operative complications and it's impact on participants
Time frame: 6 weeks, 3 months
Participants quality of life measure related to aneurysm repair throughout the study
Time frame: 6 weeks, 3 months
Participants anxiety and depression score change throughout the study 0-7 (Normal) 8-10 (Mild) 11-15 (Moderate) 16-21 (Severe)
Time frame: 6 weeks, 3 months
Difference in cigarettes usage at different phases of the study
Time frame: 6 weeks, 3 months
Measure weight change
Imperial College Healthcare NHS Trust
Other
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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