SheppheartCABG. A Randomised Clinical Trial of a Comprehensive Physical and Psycho-educative Rehabilitation Programme Plus Usual Care Versus Usual Care in Phase 1 Rehabilitation After Coronary Artery Bypass Grafting

Background: Patients undergoing coronary artery bypass grafting surgery often experience a range of problems and symptoms related to the procedure and the underlying heart disease. These problems include anxiety and depressive symptoms, immobility issues, complications such as wound seeping, neck and shoulder pains, interrupted and insufficient sleep. Over the last 2 decades, cardiac rehabilitation has become recognized as a significant component in the continuum of care for persons with cardiovascular disease. Furthermore, cardiac rehabilitation has undergone a significant evolution moving from a focused exercise intervention to a comprehensive disease management program. In Guidelines for Coronary Artery Bypass Graft Surgery cardiac rehabilitation is described as including early ambulation during hospitalisation and outpatient prescriptive exercise training beginning 6-8 weeks following surgery. Our hypothesis is that a comprehensive rehabilitation programme including physical exercise with moderate intensity and a psycho-educative component can begin in the early postoperative phase during hospitalising.

No studies have tested a combined intervention on phase 1 rehabilitation in coronary artery bypass graft surgery patients. However, randomised trials with either a physical or a mental part have been conducted with positive result, but evidence is lacking for a combined intervention. Before a large randomised trial was set up a pilot trial was conducted to evaluate the feasibility of patient recruitment and intervention: to test the safety and tolerability of the intervention by patients and to provide outcome data for sample size calculations. The SheppHeartCABG pilot showed trial feasibility, safety and sufficient inclusion rate and high compliance with most elements. Outcome data from the pilot trial has been used to sample size and power calculation in this randomised clinical trial.

Objective: The objective of this trial is to investigate the benefits and harms of a phase 1 comprehensive cardiac rehabilitation programme consisting of an exercise-training and a psycho-educative component, including plus treatment as usual in patients who undergo coronary artery bypass grafting.

Design: SheppHeartCABG is an investigator-initiated randomised clinical trial with 1:1 randomisation from two sites to a comprehensive physical and psycho-educative rehabilitation programme plus usual care or usual care alone, with blinded outcome assessment.

Population: Patients 18 years or older with ischaemic heart disease, who have to undergo elective coronary artery bypass grafting, who speak and understand Danish and who provide a written informed consent will be included. The following patients will be excluded from the trial: patients at intermediate or high risk to their cardiovascular status according to guidelines, patients with neurological or orthopaedic deficits which prevent training and patients who do not wish to participate.