Mentored Prehabilitation for Patients Having Aortic Aneurysm Surgery: a Pilot Randomised Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Adherence to trial protocol by comparing weekly physical activity between the three trial groups.
研究概览
简要总结
Protocol Short Title:
POWER Study - PrehabilitatiOn Workshop and mentored Exercise programme in patients having elective aortic aneurysm Repair
Population:
Patients scheduled for elective repair of aortic aneurysm at St. Thomas' Hospital
Screening and recruitment:
Eligible participants will be identified by the vascular team; during the weekly multi-disciplinary team meeting, or via the clinical nurse specialist from tertiary referrals.
Participant information leaflets will then be sent out to eligible patients 2 weeks before the outpatient appointment.
Recruitment will be carried out during surgical outpatient appointments. Written informed consent will be obtained and participants will be randomised into three groups.
This pilot study will help us to:
- To assess feasibility of screening, recruitment and retention
- To assess adherence to intervention and blinding.
- To generate outcome data that may be used to power definitive clinical trials
Primary objective To determine the feasibility of delivery of a randomised control trial.
Secondary objective (s) To determine baseline outcome data that may be used to power a randomised control trial.
Number of Subjects/Patients A convenience sample of 15 patients per group is planned, with a total of 45 patients recruited. At GSTT 200-250 aortic aneurysm operations are performed annually. We aim to recruit 40% of those eligible and screened. This would equate to 4-6 recruited per month.
Trial Design Single-blinded, randomised, controlled pilot study.
Patients will be allocated into the following groups:
Control group:
- Current standard practice, no prehabilitation workshop.
Non-mentored group:
- Prehabilitation workshop with no further patient contact.
- Participants to be given a prehab 'pack' which includes advice and a diary card.
Mentored group:
- Prehabilitation workshop with addition of regular 'mentoring' for up to 8 weeks after the workshop.
- Participants to be given a prehab 'pack' which includes advice and a diary card.
Primary Endpoints:
- Screening and recruitment
- Retention, blinding and follow up procedures.
- Adherence
Secondary Endpoints:
To determine baseline outcome data that may be used to power a randomised control trial by examining the following:
- Composite of post-operative cardiac, respiratory and renal complications at 30 days
- Mortality at 30 days following surgery.
- Length of postoperative hospital stay
- Quality of life (EQ-5DL)- post surgery.
- Tests of activity and function
Main Inclusion Criteria
Inclusion:
Elective all aortic aneurysm repair (Willingness to return after 8 weeks for re-assessment of secondary measures) Note: *COVID PANDEMIC ADJUSTMENT: Since March 2020, 1st national lockdown. Participants are no longer required to attend the 8 week follow up in person. The Quality of life questionnaires are done over the telephone by the research practitioner. The functional assessments are now done when the participant is admitted for their surgery Participants must have an e mail address.
Exclusions:
Urgent or emergency repair Contraindications to exercise (doesn't apply for short term illness) Severe musculoskeletal disorders preventing exercise
详细描述
Introduction
Optimising fitness prior to surgery, known as prehabilitation, has the potential to reduce risk and improve post-operative outcomes by increasing functional capacity and physiological reserve. Prehabilitation strategies include educating patients with lifestyle modifications such as smoking cessation, nutrition, exercise and anxiety reduction. Deconditioning and sarcopenia has been shown to predict a higher cost amongst patients undergoing major abdominal surgery [1] and has been recently identified as an independent predictor of hospital length of stay [2], hence optimising functionality may prevent morbidity.
There is a growing need to improve outcomes in vascular surgery, yet few examples of vascular prehabilitation exist. The 2018 Get It Right First Time (GIRFT) report [3] states one of the key recommendations is to improve the use of prehabilitation and to make it more consistent via NHS England commissioning.
Multiple studies with varying prehabilitation strategies have been published in the last decade [4]. Prehabilitation has been associated with encouraging results in major colorectal and upper gastrointestinal cancer surgery [5],[6]. Data such as these have also led to the development of prehabilitation services within NHS Trusts [7].
Supervised training programmes have shown to improve patient's anaerobic threshold and fitness in patients having aortic aneurysm repairs [8],[9],[10]. A recent randomised controlled trial has provided evidence to support supervised exercise training, by suggesting improvements in postoperative outcome, length of stay, postoperative pain and complications[11]. Historically there were concerns about exercising in this cohort of patients, however recent studies has shown that aneurysm expansion does not occur with exercise and exercise is safe [11],[12].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Attending GSTT for aortic aneurysm surgery
- •Ability to walk (determined by ability to perform gait speed independently)
- •Willingness to wear the activity tracker for 8 weeks.
- •Willingness to return at 8 weeks for re-assessment of secondary outcome measures: Note: *COVID PANDEMIC ADJUSTMENT: Since March 2020, 1st national lockdown.
- •Participants are no longer required to attend the 8 week follow up in person. The Quality of life questionnaires are done over the telephone by the research practitioner. The functional assessments are now done when the participant is admitted for their surgery
排除标准
- •Urgent or emergency aneurysm repair
- •Patients who undergo emergency admission during the 8-week time frame, will be removed from the ongoing trial, but their data will be used up to that point.
- •Contraindications to exercise (doesn't apply for short term illness ( appendix 4).
- •Severe musculoskeletal disorders preventing exercise
结局指标
主要结局
Adherence to trial protocol by comparing weekly physical activity between the three trial groups.
时间窗: 18 months
Increase in activity in intervention groups of 30% or more compared to the control group as measured by the actiwatch
Subject retention and adherence to 8-week follow up and blinding
时间窗: 8 weeks
Subject wearing activity tracker for greater than 80% of the time, 80% or more attendance to 8-week follow up \* and 80% or more maintenance of blinding. \*COVID PANDEMIC ADJUSTMENT: Participants are no longer required to attend the 8 week follow up in person. The Quality of life questionnaires are done over the telephone by the research practitioner. The functional assessments are now done when the participant is admitted for their surgery
Feasibility of screening and recruitment: recruitment ratio
时间窗: 18 months
Screening: recruitment ratio of 3:1
次要结局
- Composite of post-operative cardiac complications at 30 days(30 days post surgery.)
- Composite of post-operative respiratory complications at 30 days(30 days post surgery)
- Mortality at 30 days(30 days post surgery)
- Quality of life (QoL) EQ-5D(18 months)
- Composite of post-operative renal complications at 30 days(30 days post surgery)
- Length of hospital stay(18 months)
- Tests of activity and function(8 weeks)