CABGpreHAB- Home-based Multimodal Prehabilitation (CABGpreHAB) for Elective Patients Awaiting CABG-surgery - a Feasibility Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Feasibility outcome: recruitement rate
研究概览
简要总结
Patients with ischemic heart disease (IHD) awaiting coronary artery bypass graft (CABG) surgery often face challenges like advanced age, frailty, comorbidities, and physical inactivity. These factors, combined with the physiological and psychological stress of surgery, can hinder postoperative recovery. Traditionally, strategies to improve surgical outcomes focus on the intra- and postoperative periods. However, the pre-surgery waiting period offers a "window of opportunity" for prehabilitation, which aims to enhance patients' functional capacity through exercise, nutrition, and psychological support.
The CABGpreHAB feasibility study evaluates the feasibility of a home-based multimodal prehabilitation intervention for patients awaiting elective CABG surgery. This randomized pilot study compares the intervention plus usual care to usual care alone, assessing feasibility outcomes like recruitment, retention, attrition, fidelity, and adherence. The study aims to optimize a subsequent full-scale randomized controlled trial (RCT) and improve patient outcomes by leveraging the pre-surgery period for prehabilitation.
详细描述
Advanced age, frailty, comorbidity, and physical inactivity are often present in patients with ischemic heart disease (IHD) awaiting coronary artery bypass graft surgery (CABG). These characteristics, as well as the physiological impact of having surgery, are significant homeostatic disturbances where patients postoperatively suffer from physical symptoms and a lack of return to independence. Cardiac surgery invariably induces varying degrees of physiological stress, impacting multiple organ systems, and imposes a psychological burden. As age increases, patient complexity and comorbid burden grow more common in patients undergoing cardiac surgery; innovative strategies are required to alleviate the risk of adverse outcomes. Strategies to improve outcomes from surgery and accelerate return to baseline levels have traditionally focused on the intra- and postoperative period, nevertheless, the waiting period before surgery might offer an opportunity for improving the safety and outcome of the surgical intervention and improving patients' motivation in postoperative rehabilitation and recovery time. Prehabilitation is a newly introduced term that reflects a proactive process of enhancing an individual's functional capacity between diagnosis and scheduled surgery, intending to improve the patient's capacity to withstand the upcoming physiologic stress of surgery and thus avoid complications. This period of awaiting surgery is proposed as a "window of opportunity" to address poor nutritional status, low physical fitness, and high emotional distress. The role of multimodal prehabilitation combining exercise training, nutritional optimization, and psychological support, in patients with IHD awaiting CABG surgery, is sparse and unknown in a Danish setting
Objective:
This CABG preHAB feasibility study is conducted to evaluate the feasibility of delivering a homebased multimodal prehabilitation intervention for patients awaiting elective CABG surgery with the purpose to optimize a subsequent full-scale RCT.
Design:
The CABGpreHAB feasibility study is designed as a randomized pilot study, aiming to assess the feasibility of a multimodal prehabilitation intervention plus usual care versus usual care alone in patients awaiting elective CABG surgery. It is an investigator-initiated study designed as an open-label, single-center randomized controlled feasibility study (allocation ratio 1:1) with blinded outcome assessment, designed to assess the method proposed for use in a larger RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned to have elective isolated first-time CABG surgery.
- •18 years or older
- •Two weeks or more before surgery
- •Speaks and understands Danish.
- •Gives written informed consent.
排除标准
- •Patient with unstable angina pectoris and/ or MI during the last two weeks.
- •Left main stem stenosis >50%
- •Left ventricular ejection fraction < 35%
- •Significant ventricular arrhythmia
- •Orthopedic or neurologic preconditions precluding exercise training.
- •Inability to attend the prehabilitation program due to physical limitations.
- •Patients who have cognitive deficits that would disqualify prehabilitation.
- •Severe heart failure, NYHA Class IV
- •Lack of capacity to consent
研究组 & 干预措施
CABGpreHAB multimodal prehabilitation intervention + usual care
Patients randomized to the multimodal prehabilitation programme will, besides usual care, receive home-based preoperative interventions that consist of:
Web-based exercise intervention supervised by skilled physiotherapists and delivered via a tablet. Each session lasts 60 minutes, three times per week for the prehabilitation period. Patients will be instructed to perform daily exercise tasks such as brisk walking and sit-to-stand exercises.
Phone call and consultation delivered by a specialised nurse once a week. This consultation will deliver psychosocial support, equipping patients with coping strategies to mitigate stress, anxiety, and depression. Furthermore, nutritional advice will take place at these consultations, as well as advice on smoking cessation and alcohol cessation.
干预措施: Multimodal prehabilitation intervention (Other)
Control group
Participants assigned to the control group will receive usual care.
干预措施: Control (Standard treatment) (Other)
结局指标
主要结局
Feasibility outcome: recruitement rate
时间窗: Through study completition, an average of 1 year
Determined by the number of individuals participating in the study out of those eligible during the inclusion period.
Feasibility outcome: Attrition rates
时间窗: Up to 30 days post surgery index
Defined by the numbers of individuals who give consent to participate, but drop out before study ends.
Feasibility outcome: Fidelity
时间窗: preoperative
Fidelity of delivery on the web-based exercise training intervention will be assessed qualitatively by semi-structured interviews
Feasibility outcome: Adherence rates
时间窗: Preoperative
Adherence will be assessed by measuring the number of telephone counseling and exercise sessions delivered during the intervention period.
Feasibility outcome: Safety
时间窗: From enrolement to the day before surgery
Safety of the intervention will be determined based on the number and nature of adverse events.
次要结局
- Exercise capacity(Three times: at baseline, preoperative and 30 days post surgery index)
- Muscle strength(Three times: at baseline, preoperative and 30 days post surgery index)
- Muscle strength handgrip(At baseline and preoperative)
- Bodycomposition(At baseline and preoperative)
- Nutritional status(At baseline and preoperative)
- Daily physical activity(Three times: at baseline, preoperative and 30 days post surgery index)
- HRQOL(Three times: at baseline, preoperative and 30 days post surgery index)
- Heart-specific QoL(Three times: at baseline, preoperative and 30 days post surgery index)
- Anxiety(Three times: at baseline, preoperative and 30 days post surgery index)
- Depression(Three times: at baseline, preoperative and 30 days post surgery index)
- Sense of coherence(At baseline)
- Self-efficacy/self-management(Three times: at baseline, preoperative and 30 days post surgery index)
- Tobacco uses status(Three times: at baseline, preoperative and 30 days post surgery index)
- Alcohol uses status(Three times: at baseline, preoperative and 30 days post surgery index)
研究者
Dorte Bæk Olsen
Clinical Nurse Specialist
Rigshospitalet, Denmark