“Super Rehab”: Can we achieve coronary artery disease regression in metabolic patients? (a feasibility study)

Background Coronary artery disease (CAD) continues to cause significant morbidity and mortality in the UK. CAD is a progressive inflammatory condition that results in plaque deposition in the vascular wall of coronary arteries. Approximately half of patients with CAD have metabolic syndrome (MetS), and risk of mortality from myocardial infarction in CAD patients with MetS (CAD-MetS) is 3-fold higher than in other CAD patients. Current treatment and management of CAD focusses on plaque stabilisation (e.g., via medications and expensive invasive treatments such as stents), but recent research indicates that it is possible to achieve CAD regression with substantial changes to lifestyle (diet and exercise). Such intensified interventions are not currently available via the NHS. Thus, in line with the NHS Long Term plan, we will examine the feasibility of implementing intensified lifestyle intervention (Super Rehab) in higher risk CAD patients (CAD-MetS). Our longer-term goal is to use Super Rehab for patients with CAD-MetS throughout the NHS to significantly improve patient outcomes (including plaque regression) and generate substantial long-term cost savings. Research Question Is it feasible to conduct a randomised, controlled trial of an intensified dietary and exercise intervention (Super Rehab) in CAD-MetS patients, with the aim of reversing CAD? Aims To test the feasibility of undertaking a randomised controlled trial (RCT) evaluating whether Super Rehab can induce coronary regression in CAD-MetS patients, assessing: 1) recruitment, retention and adherence rates, 2) intervention acceptability, 3) data collection and analysis, and 4) the proposed cost-effectiveness framework. Methods We will conduct a multi-centre, two parallel-arm, randomised feasibility study of Super Rehab in individuals with CAD-MetS. We will enrol 50 individuals (25 intervention, 25 control) across South West England. Participants will be allocated 1:1 to Super Rehab or usual care, with both groups continuing usual care. Super Rehab will incorporate high-intensity, 1:1 supervised exercise, prescribed home-work exercise and personalised dietary support led by a nutritionist. The overall multi-disciplinary team will be led by a Consultant Cardiologist. Session frequency will reduce over a 12-month period across 3 phases (induction, consolidation, maintenance). Key assessments will be undertaken at 0, 6, 12 and 3 month follow-up at 15 months with end-of-study qualitative interviews of participants and the multi-disciplinary delivery team. Timelines for delivery Months 1-3: Secure ethics approvals and finalise project infrastructure and recruitment processes. Months 4-10: Recruit 50 participants, secure consent, randomisation, and complete assessments. Months 4-22: Delivery of intervention, all assessments. Months 23-24: Data analysis (quantitative and qualitative), manuscript preparation, initiate proposal for RCT, dissemination and study closure. Anticipated Impact & Dissemination This feasibility study will inform a definitive, multicentre RCT to establish the impact of Super Rehab in CAD-MetS patients. Results will be disseminated via peer-reviewed publications, conference presentations and websites to a wide audience including clinicians, researchers and patients. If the subsequent multi-centre RCT shows that Super Rehab is cost-effective, we would work with key stakeholders to promote the implementation of Super Rehab in this target population across the NHS.

Heart disease affects many people in the UK and is a leading cause of early death. About half the people with heart disease have “metabolic syndrome”, which means that they have high blood pressure, obesity and difficulties controlling the sugar and fat in their blood. People with heart disease and metabolic syndrome are at much higher risk for more severe heart disease, heart attacks and early death. Current heart disease treatments focus on medications and operations to overcome the “furring-up” of people s heart blood vessels. These treatments carry a risk and are very expensive for the NHS. Recent research shows that intensive lifestyle programmes (improving exercise and diet) can reverse diseases like certain forms of diabetes. There is some evidence that lifestyle programmes can improve aspects of heart health and reduce the number of medications people need. However, there is no conclusive evidence showing that lifestyle programmes reduce the “furring-up” in people s blood vessels. Evidence is needed before these programmes are made available in the NHS. In this study, we will assess whether it is possible to introduce a new intensive lifestyle programme (“Super Rehab”) into the care of patients who have heart disease with metabolic syndrome. We will assess whether Super Rehab (intensive exercise and changes in diet) can be delivered, check whether patients like the programme and see if lifestyle changes are kept up as the level of supervision is reduced. The findings from this smaller (feasibility) study will help us to decide if we should carry out a larger multi-hospital trial to conclusively determine if Super Rehab improves the furring up of people s blood vessels and heart health. In this feasibility study, fifty patients will be recruited from an NHS hospital and chosen at random to participate in Super Rehab or carry on with their usual care. Super Rehab involves 10 weeks of 1:1 supervised intensive exercise sessions alongside changes to diet. After this intensive phase, supervision is reduced little-by-little up to 12-months to help patients become self-sufficient. Patient views will be collected and tests of health (including heart health) will be taken at the beginning, middle and end of the study. We will meet regularly with a patient advisory group to get their views on the study, including study leaflets. We will present the results to patient groups and clinicians, as well as sharing the results in journals and at conferences. If we can show that Super Rehab is feasible, we plan to conduct a larger study to measure the impact of Super Rehab on the amount of “furring” in people s blood vessels. Evidence from this larger study would help the NHS to decide whether Super Rehab should be offered to patients across the country.