Improvement in walking ability, ankle pressure indices and quality of life in vascular claudication using intermittent pneumatic foot and calf compression: a randomized controlled trial

Abstract

Abstract Background Perioperative mortality, graft failure and limitations of balloon angioplasty mitigate against active intervention for claudication. With the exception of exercise programmes, conservative treatments yield modest results. Intermittent pneumatic compression (IPC) of the foot used daily for over 3 months enhances significantly the walking ability and pressure indices of stable claudicants. This prospective randomized study evaluated the effects of IPC of the foot and calf simultaneously (IPCfoot + calf) on the walking ability, arterial haemodynamics and quality of life of patients with intermittent claudication. Methods Forty-one stable claudicants, meeting stringent inclusion and exclusion criteria, were randomized to receive either IPCfoot + calf and 75 mg aspirin (group 1; n = 21) or 75 mg aspirin alone (group 2; n = 20), with stratification for diabetes and smoking. Groups matched for age, sex, initial (ICD) and absolute (ACD) claudication distance, ankle: brachial pressure index (ABPI), popliteal artery flow (Q) and quality of life (Short Form (SF) 36 questionnaire). IPCfoot + calf (120 mmHg, three cycles per min, inflation 4 s, proximal inflate delay 1 s) was used for 2·5 h daily for 5 months consecutively. Both groups were advised to exercise unsupervised. Evaluation of patients, after randomization, included: (a) ICD and ACD on a treadmill, (b) resting and postexercise ABPIs, (c) Q using duplex imaging, and (d) quality of life. Study time-points were: baseline and 1, 2, 3, 4, 5 and 17 months. Compliance was assessed by means of a log book. Non-parametric statistical analysis was used (Wilcoxon and Mann–Whitney tests). Results After 5 months of IPCfoot + calf median ICD, ACD, resting and postexercise ABPI in group 1 increased by 197, 212, 17 and 64 per cent (all P < 0·001) respectively; changes in group 2 were all non-significant (P > 0·1). On intergroup comparison at 5 months, patients in group 1 were better than those in group 2 in terms of ICD, ACD, resting and postexercise ABPI (all P < 0·01). Q changes within this period were not significant in either group; neither were intergroup Q differences (P > 0·1). Associated changes in the quality of life within group 1 at the end of month 5 were significant; non-significant changes were noted in group 2. At 5 months patients in group 1 enjoyed a better quality of life than those in group 2 (P < 0·01). IPCfoot + calf use did not result in any complications. The daily IPCfoot + calf compliance (2·5 h per day) was greater than 82 per cent in the first month and greater than 85 per cent in months 2–5. One year after the end of IPCfoot + calf application, patients in group 1 maintained the improved ABPI and walking benefit. Conclusion IPCfoot + calf emerged as an effective, high-compliance, uncomplicated method for improving the walking ability and pressure indices in patients with stable claudication, with a confirmed durable outcome. These changes are associated with a significant improvement in all aspects of quality of life evaluated by the SF-36. Despite a limited benefit noted in some individuals, unsupervised exercise had a non-significant impact overall.