About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Planned to have elective isolated first-time CABG surgery.
18 years or older
Two weeks or more before surgery
Speaks and understands Danish.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Multimodal prehabilitation intervention
Other interventionMultimodal prehabilitation interventions (CABGpreHAB): * Home-based exercise intervention delivered by a skilled physiotherapist via a web-based application. * Nutritional intervention * Psycho-educative intervention * Smoking cessation * Alcohol cessation
Control (Standard treatment)
Other interventionThis 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.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility outcome: recruitement rate
Determined by the number of individuals participating in the study out of those eligible during the inclusion period.
Feasibility outcome: Attrition rates
Defined by the numbers of individuals who give consent to participate, but drop out before study ends.
Feasibility outcome: Fidelity
Fidelity of delivery on the web-based exercise training intervention will be assessed qualitatively by semi-structured interviews
Feasibility outcome: Adherence rates
Adherence will be assessed by measuring the number of telephone counseling and exercise sessions delivered during the intervention period.
Secondary outcomes
Exercise capacity
6MWT measures total walking distance in meters completed in six minutes
Muscle strength
30 seconds sit-to-stand measured by numbers of sit-to-stands in 30 seconds
Muscle strength handgrip
Measured in kilograms using a hand-held dynamometer
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
Other outcomes
Complications postoperatively
Rates of pneumonia, atelectasis, hemorrhage, cardiac arrhythmias, and delirium will be measured postoperatively
ICU-LOS
ICU-LOS will be calculated in hours
LOS
LOS will be calculated in days
DAOH30
DAOH30 will be calculated in days
Sponsors and contacts
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