Maximising Recovery to Health Through Trimodal (Bio Psycho Social) Prehabilitation for Aneurysm Surgery Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 主要终点
- The Number of Patients Who Accepted Inclusion Into a Pre-operative Prehabilitation Programme
研究概览
简要总结
DESIGN: Single-centre, feasibility study AIMS: The aim of this study is to evaluate the acceptability and pre-operative impact on functional capacity of a trimodal prehabilitation program in a cohort of patients undergoing aneurysm repair.
This will enable the design (feasibility and power) of a large scale Randomised Controlled Trial.
Expected outcomes
- The potential number of patients who would benefit, the compliance and acceptability of a pre-operative prehabilitation programme will be calculated.
- Preoperatively, expected at 6-weeks, the change in physical fitness of patients (assessed by the physical function section of SF-36 and measured with peak flow/6-minute walk testing) during the pre-operative phase will be assessed in both groups.
- The effects on quality of life, anxiety and depression on each study participant will be assessed immediately pre-op, expected at 6-weeks.
- The number of patients who are able to reduce or cease smoking will be reported during the pre-op phase (expected at 6 weeks), as will length of hospital stay after aortic surgery, expected at 6-8 weeks.
POPULATION: Patients undergoing planned elective aortic surgery procedures
ELIGIBILITY: Adult patients (over 18 years) undergoing elective open and endovascular aneurysm repair with capacity to consent and physical fitness to undergo an pre-operative exercise programme DURATION: 1 year from 1st June 2014
详细描述
Proposed intervention - The introduction of a biopsychosocial intervention before surgery. The physical exercise programme will be a prescribed exercise training twice per week which will be supported by a physical therapist and vascular nurse specialist. A trained clinical psychologist will also deliver a brief psychological intervention based on cognitive behavioural therapy (CBT) techniques in two sessions to modify illness, surgical preparation and rehabilitation beliefs. Lastly patients will be counselled and referred to smoking cessation services as appropriate by the vascular nurse specialist.
Baseline information will include patient demographics and medical history, quality of life assessment using SF-36 forms, hospital anxiety and depression scale (HADS) and exercise testing by a standardised 6-minute walk test Information immediately pre-operatively will be collected to include a repeat assessment of physical function with a 6-minute walk test, SF-36 assessment and HADS scores. Smoking cessation rate will be collected.
A pre and post-intervention group will be studied over a 1-year period. We will report on the eligibility, acceptability and pre-operative effect of this trimodal rehabilitation programme.
AIM AND EXPECTED IMPACT
This is a non-randomised pre-post intervention pilot study to understand the acceptability and pre-operative effects of a combined physical, psychological and social prehabilitation package in patients undergoing aneurysm repair. This will enable the design (feasibility and power) of a large scale Randomised Controlled Trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Open label
入排标准
- 年龄范围
- 40 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing elective repair, willing/able to undertake a period of prehabilitation, and those able to comprehend and retain instructions regarding self-training.
排除标准
- •Symptomatic patients or those undergoing urgent treatment (< 2 weeks)
研究组 & 干预措施
Pre-intervention
Patients treated as standard before intervention
Post-intervention arm = Prehabilitation
Introduction of rehabilitation program
干预措施: Post-intervention arm = Prehabilitation (Behavioral)
结局指标
主要结局
The Number of Patients Who Accepted Inclusion Into a Pre-operative Prehabilitation Programme
时间窗: Collected at screening
This describes the number of people within the study who were in the pre-habilitation study arm that accepted and completed the pre-habilitation training
Number of Participants With Attendance at the Physical and Psychological and Social Training Appointments of the Rehabilitation Programme (Assessed by Bespoke Questionnaire)
时间窗: Collected at baseline and during the study
Change From Baseline in Metabolic Equivalents (METS) at Six Weeks
时间窗: Collected at baseline and (expected) 6 weeks
• Metabolic equivalent level is a measure of physical fitness. One MET is defined as 3.5 mL 02 uptake/kg per minute which is the resting oxygen uptake in a sitting position. The achieved exercise capacity in METs has been shown to be predictive in older adult population of survival with higher MET levels associated with improved survival," or similar definition that is accurate and appropriate.
Decrease in Anxiety and Depression Scores (Hospital Anxiety and Depression Scale)
时间窗: Collected at baseline and (expected) 6 weeks
HADS is a validated questionnaire consisting of 7 statements relating to anxiety and 7 statements relating to depression. Each statement is scored between 0 and 3 giving a total score of up to 21 for each section. A score of 0-7 is assumed to be normal and score greater than this suggestive of a mood disorder
次要结局
- HDU/ITU Resource Use (Number of Days Stay)(Collected at (expected) 6 weeks +hospital stay)
- LOS(Collected at (expected) 6 weeks +hospital stay)