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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.
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.
Study population:
Patients aged more than 18 years awaiting elective CABG-surgery
Primary outcomes:
Feasibility outcomes include:
Recruitment and retention rates. The recruitment rate will be determined by the number of individuals participating in the study out of those who are eligible/admissible but refuse to participate. First, the investigators will evaluate the number of patients that can be included in the study during the inclusion period. A proportion of 60% or more of patients awaiting elective CABG surgery who are eligible for the study is acceptable. Retention will be assessed by the percentage of participants who remain in the study from the beginning to the end of the study (30 days post-surgery).
Attrition rates. Attrition is defined by the number of individuals who consent to participate in the study but drop out before the end of the intervention period, regardless of group allocation.
Fidelity. Fidelity of delivery of the webcam-based exercise training intervention will be assessed qualitatively by 8-10 semi-structured interviews, the day before surgery, by a research nurse.
Adherence to the interventions will be measured by using the number of telephone counselling and tele-exercise sessions delivered out of the theoretical number that could have been delivered based on the surgical wait time of each participant. Adherence to the home-based tele-exercise training sessions and telephone counselling by assessing the number of sessions applied in the intervention group. This will be collected by the patient's recorded physical activity logbook, by weekly phone calls, and by accelerometer data. Adherence with the prehabilitation program will be assessed against the target of individuals achieving > 70% of the prescribed exercise program (self-reported) + during the study follow-up with phone calls. Inclusion in the CABGpreHAB study must be attractive to at least 30% of eligible patients who meet the inclusion criteria. The interventions must be widely accepted, with at least 70% of included participants completing 70% or more of the planned sessions in the intervention group. Safety of the intervention will be determined based on the number and nature of adverse events (AE).
Secondary outcomes:
Secondary outcomes will assess the patients' responses to the multimodal prehabilitation programme, and data will be collected on explorative outcomes, measured at baseline, the day before surgery and 30 days PO.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CABGpreHAB multimodal prehabilitation intervention + usual care | Experimental | 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. |
|
| Control group | Other | Participants assigned to the control group will receive usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal prehabilitation intervention | Other | Multimodal prehabilitation interventions (CABGpreHAB):
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility outcome: recruitement rate | Determined by the number of individuals participating in the study out of those eligible during the inclusion period. | Through study completition, an average of 1 year |
| Feasibility outcome: Attrition rates | Defined by the numbers of individuals who give consent to participate, but drop out before study ends. | Up to 30 days post surgery index |
| Feasibility outcome: Fidelity | Fidelity of delivery on the web-based exercise training intervention will be assessed qualitatively by semi-structured interviews | preoperative |
| Feasibility outcome: Adherence rates | Adherence will be assessed by measuring the number of telephone counseling and exercise sessions delivered during the intervention period. | Preoperative |
| Feasibility outcome: Safety | Safety of the intervention will be determined based on the number and nature of adverse events. | From enrolement to the day before surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise capacity | 6MWT measures total walking distance in meters completed in six minutes | Three times: at baseline, preoperative and 30 days post surgery index |
| Muscle strength | 30 seconds sit-to-stand measured by numbers of sit-to-stands in 30 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| Complications postoperatively | Rates of pneumonia, atelectasis, hemorrhage, cardiac arrhythmias, and delirium will be measured postoperatively | From date of surgery and up to 30 days postopetively. |
| ICU-LOS |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dorte Baek Olsen, PhD student | Contact | +4526625705 | dorte.baek.olsen@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Ida E Hoejskov, PhD | Department of Heart Disease, Rigshospitalet, Copenhagen University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Department of Heart and Lung Surgery, Copenhagen University hospital Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 20, 2025 | Jun 16, 2025 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Control (Standard treatment) | Other | This includes standard information about CABG surgery, pre- and postoperative care, and postoperative physical activity advice. Patients are either admitted days before or on the day before surgery. They receive written materials and links to animated videos about preparing for surgery. This preparation includes counseling with a multidisciplinary team, including a department nurse, a physiotherapist, a cardiac anesthesiologist, and a surgeon. |
|
| Three times: at baseline, preoperative and 30 days post surgery index |
| Muscle strength handgrip | Measured in kilograms using a hand-held dynamometer | At baseline and preoperative |
| Bodycomposition | Using a Bioelectrical Impedance Analyzer (BIA), body composition estimation: fat mass in kilograms, Fat mass as a percentage of weight, Fat-free mass in kilograms, Fat-free mass as a percentage of weight | At baseline and preoperative |
| Nutritional status | Weight and height combined to report BMI in kg/m^2, and Screened by the NRS2002 score | At baseline and preoperative |
| Daily physical activity | SENS motion accelerometer measures minutes of physical activity as steps, Cyckling running Standing Laying | Three times: at baseline, preoperative and 30 days post surgery index |
| HRQOL | The Questionnaire SF-12 measures overall health status | Three times: at baseline, preoperative and 30 days post surgery index |
| Heart-specific QoL | The Questionnaire HeartQoL measures health-related quality of life in patients with ischemic heart disease | Three times: at baseline, preoperative and 30 days post surgery index |
| Anxiety | The State-Trait Anxiety Inventory Questionnaire measures two disitnc types of anxiety | Three times: at baseline, preoperative and 30 days post surgery index |
| Depression | The PHQ-4 Questionnaire measures depression and anxiety | Three times: at baseline, preoperative and 30 days post surgery index |
| Sense of coherence | The SOC-13 Questionnaire assesses an individual´s ability to manage stress and maintain health | At baseline |
| Self-efficacy/self-management | The PAM13 Questionnaire assesses an individual's knowledge, skill, and confidence for self-management | Three times: at baseline, preoperative and 30 days post surgery index |
| Tobacco uses status | Self-Reported Questionnaire | Three times: at baseline, preoperative and 30 days post surgery index |
| Alcohol uses status | Self-Reported Questionnaire | Three times: at baseline, preoperative and 30 days post surgery index |
ICU-LOS will be calculated in hours
| From date and time of surgery until the date and time of discharge to the ward. |
| LOS | LOS will be calculated in days | From date of surgery until date of discharge from the ward |
| DAOH30 | DAOH30 will be calculated in days | From date of surgery and up to 30 days postopetively. |
| Participating in Cardiac rehabilitation | Participation will be calculated in percentage | At 30 days postoperatively |
| Bloodtest | HGB measured in mmol/l Albumin measured in g/l CRP measured in mg/l Creatinine measured in micromol/l | At baseline and postoperatively day 4 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |