Exploring the feasibility of using home- and blood flow restriction-based exercise in combination with health coaching for the management of peripheral arterial disease
Peripheral arterial disease
This is a three-phase study (comprising intervention design and feasibility), informed by the MRC complex interventions framework, using both qualitative (Phase 1: a participatory approach based on focus groups/interviews) and mixed methods (Phase 2: RCT; Phase 3: qualitative study). Total study duration will be 36 months. Phase 1 (intervention co-production): We will gather the views and opinions of pPAD in 3-4 focus groups and/or additional interviews, with the aim of co-designing the intervention format and content, as well as all relevant participant-facing material. Co-designing will be evidence-based; the home-based exercise programme will be centred on published evidence about exercises and on our successful BFR community intervention. Once this information is collected, we will work collaboratively with our PPIE group to produce the intervention, therefore ensuring that the information collected is translated successfully into a practical tool, that participant burden is kept to a minimum and that the documents and resources’ wording is appropriate. We will then conduct a workshop (n = 6) to pilot-test adapted ideas, tools, and resources. Phase 2 (feasibility): Following eligibility confirmation, an appointment will be made for baseline measurements to take place (VISIT 1; 60 minutes). Baseline measurements will be repeated at 3 months (visit 2) and 6 months (visit 3). During follow-up visits, assessors will review participants’ paper resource use diary, as used successfully in our previous feasibility trials. This will be completed by participants during the 6-month intervention, aiming to collect information on PAD-related healthcare visits and expenses to assist in the health-economic exercise. A decision on whether this will be paper- or online-based (alongside all other participant materials) will be made in Phase 1. On follow-up visits, we will also collect information on any exercise-related, non-study-prescribed activities that participants from bo
1. Patients with PAD with stable claudication (i.e., symptomatic presentation unchanged for 6 months) 2. Ankle–brachial index (ABI) ≤0.9
1. Stents in the artery system of the thigh; symptomatic presentation of rest pain, skin ulcers, or gangrene 2. Impaired walking by a non-PAD condition (e.g., hip or knee osteoarthritis) or cannot walk without a walking aid