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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Acceptability of the prehabilitation programme (Patient satisfaction)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •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
结局指标
主要结局
Acceptability of the prehabilitation programme (Patient satisfaction)
时间窗: 18 months
Patient satisfaction will be measured using questionnaires Reasons for drop-out will be captured.
Feasibility of screening and recruitment
时间窗: 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:
时间窗: 18 months
Time taken to complete the questionnaires at each time-point The ratio of missing data from questionnaires Follow-up response rates
Adherence
时间窗: at least 6 weeks ( Duration of the programme)
Number of sessions attended The proportion of participants who complete' the 6-week programme
次要结局
- Change in 6-minute walk test (6-MWT) at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)(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)(6 weeks, 3 months)
- In-Hospital Complication Rate(Immediately after the surgery)
- Length of stay and readmission rates (30 days post-surgery)(30 days)
- Change in aneurysm specific quality of life scores at end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)(6 weeks, 3 months)
- Post-Operative Morbidity score (POMS)(Immediately after surgery)
- Change in cigarettes usage per day(6 weeks, 3 months)
- 30-day(After surgery) Composite Outcome(30 days)
- Change in Hospital Anxiety and Depression Score (HADS) end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)(6 weeks, 3 months)
- Change in weight (in kg) end of programme, Discharge, 6-weeks (Post discharge) and 3 months (Post Discharge)(6 weeks, 3 months)