Discussion
exertional leg symptoms, claudication, pain
RECRUITMENT
The aim of the study was to evaluate the feasibility of a supervised BFR program in patients with claudication. The primary finding was that BFR was feasible in patients with claudication with all success criteria being met. Additionally, it was shown that BFR has the potential to increase exercise performance, reduce pain, and improve QoL. Our findings support the progression to a definitive, multicenter trial to evaluate the clinical and cost-effectiveness of BFR in patients with claudication.A key element of the success of the trial was patient recruitment. The target number of patients was achieved within the trial timeframe despite the COVID-19 pandemic imposing substantial pressure on clinical services. A strong commitment by the clinical team to approach, promote, and invite was the driving force of recruitment, alongside a flexible and friendly approach from the research team, which will be a decisive factor for the success of a definitive trial. Another recruitment success component was contributed to by the Sheffield Vascular Institute delivering claudication-specific clinics. This likely increased the frequency of screening patients who fit the inclusion criteria, which is evident by the high eligibility rates observed in the study.Despite recruitment rates in the study being acceptable, they could be improved. From eligible patients who were invited to the study but declined, 29% of the responses were due to inability to travel to the study location. The difficulty/inability to travel to central exercise locations from the city outskirts because of time, cost, or accessibility poses a significant barrier to participation for many patients.High adherence rates for BFR are an encouraging sign of the acceptability of this exercise method in patients with claudication, which was supported by the implementation of the six pillars of adherence framework developed by our team.A contributing factor to high adherence could be attributed to the frequency of sessions and program duration employed in the study, which is relatively low compared to traditional exercise prescription for this patient group of three times a week for 12–24 weeks.The outcomes of the 6MWT in the present study hold potential for explaining in a fully powered randomized trial the extent to which BFR could affect walking performance in patients with claudication. The 6MWT is a well-validated measure of walking performance which reflects normal walking and requires minimal resources.Though the data in the present study should not be over-interpreted, it is encouraging to observe a 15% group increase in 6MWT distance, of which 86% of patients increased their 6MWT distance by > 35.5 m, which represents a large clinically important difference,BFR augmented cardiovascular responses, exertion, and pain, which may be indicative of a stimulus that improves cardio-respiratory physiology and muscle conditioning that can increase exercise performance.Supervised resistance exercise programs have repeatedly been shown to improve claudication onset distance and total walking distance in patients with claudication.This study has presented a novel exercise mode which has potential for improving exercise performance, QoL, and exertional leg symptoms in patients with claudication. Conducting this feasibility trial has allowed procedures and protocols to be tested. Modelling an intervention before a full-scale evaluation can identify weaknesses, lead to refinement, and indicate whether a full-scale trial is warranted.