CABGpreHAB - a Feasibility Study Protocol

Condition(s) studied

Investigational drug(s) / intervention(s)

Multimodal prehabilitation intervention: Multimodal 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): 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.

Study summary

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

Primary outcome measure(s)

• Feasibility outcome: recruitement rate — 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 — 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 — preoperative
  Fidelity of delivery on the web-based exercise training intervention will be assessed qualitatively by semi-structured interviews
• Feasibility outcome: Adherence rates — Preoperative
  Adherence will be assessed by measuring the number of telephone counseling and exercise sessions delivered during the intervention period.
• Feasibility outcome: Safety — From enrolement to the day before surgery
  Safety of the intervention will be determined based on the number and nature of adverse events.

Trial sites (1)

Other trials for the same condition