Rehabilitation for individuals with chronic limb threatening ischaemia post-revascularisation (HOPE): a co-created feasibility trial.

Research question: Is a purpose-built rehabilitation intervention co-developed with patients and experts feasible to be used in people with Chronic limb threatening ischemia (CLTI) after surgery? Background: One in five people over the age of 60 in the UK have Peripheral Artery Disease (PAD).

The most advanced form of PAD is chronic limb threatening ischaemia (CLTI) where patients present with severe leg pain and/or gangrene.

CLTI is limb and life threatening and requires urgent revascularisation (open and/or endovascular surgery) to restore blood flow to the lower limbs.

However, despite revascularisation, individuals with CLTI are still at risk of amputation or death, with 1- and 3-year mortality up to 50%, incidence of major adverse cardiovascular events (MACE) at 42% and 1-and-3-year amputation rates reaching 20%.

People with CLTI have limited or no walking capacity, low levels of fitness, sedentary lifestyle, poor quality of life (QoL) and are sarcopenic and frail. These are all independent predictors of mortality and morbidity. After surgery and without a secondary prevention strategy, these clinical outcomes will only further decline.

Therefore, this population urgently requires evidence-based rehabilitation.

In those with claudication, exercise after revascularisation is seen as an optimal strategy in terms of cost effectiveness and improving walking distance (290m increase; p < 0.001) .

However, it is unknown if this is an appropriate strategy for those with CLTI post revascularisation due to no available evidence.

Aims and Objectives: Develop and test the feasibility of a co-developed rehabilitation intervention for individuals with CLTI post revascularisation. To achieve this aim, we have two objectives: 1.

Co-develop a rehabilitation intervention with individuals with CLTI post revascularisation, carers and healthcare professionals (Phase 1), 2. To assess the feasibility of the intervention (Phase II).

Methods: A three round modified Delphi (each round N= 30) study with representation from individuals with CLTI /carers and healthcare professionals (e.g., nurses) will be used to co-design and co-refine a rehabilitation intervention (Phase 1).

Phase 2 will be a single arm multi-centre feasibility study to assess the intervention in patients undergoing surgery (open or endovascular) for CLTI (N=30).

Recruitment, adherence, retention, safety, patient reported and clinical measures (quality of life, walking capacity, physical function, anxiety and depression, cardiovascular events and mortality) will be assessed.

Interviews and focus groups will also be conducted in individuals with CLTI and stakeholders to further assess acceptability and recruitment.

Timelines for delivery: Total project duration 24 months, including Phase 1 set up and delivery (0-6 months), Phase 2 set up, recruitment, delivery and analysis (6-24 months), Anticipated Impact and Dissemination: We will publish our results in an open-access peer-review journal and disseminate the findings at a conference to both patients (lay summaries) and experts.

This study has the potential to rapidly influence international guidelines regarding the delivery of rehabilitation programmes for patients with CLTI, potentially saving lives, legs, and reducing NHS costs.

This study will inform a national randomised definitive trial to investigate the clinical and cost-effectiveness of the intervention which may lead to NHS-wide adoption.