Effect of intermittent pneumatic compression of foot and calf on walking distance, hemodynamics, and quality of life in patients with arterial claudication - A prospective Randomized controlled study with 1-year follow-up

Summ. Background Data: Perioperative mortality, graft failure, and angioplasty limitations militate against active intervention. for claudication. With the exception of exercise programs, conservative treatments yield modest results. Intermittent pneumatic compression [IPC] of the foot used daily for 3 months enhances the walking ability and pressure indices of claudicants. Although IPC applied to the foot and calf together [IPCfoot+calf] is hemodynamically superior to IPC of the foot, its clinical effects in claudicants remain undetermined. Objective: This prospective randomized controlled study evaluates the effects of IPCfoot+calf on the walking ability, peripheral hemodynamics, and quality of life [QOL] in patients with arterial claudication. Methods: Forty-one stable claudicants, meeting stringent inclusion and exclusion criteria, were randomized to receive either IPCfoot+calf and aspirin[(75 mg)] (Group 1; n = 20), or aspirin[(75 mg)] alone (Group 2; n = 21), with stratification for diabetes and smoking. Groups matched for age, sex, initial [ICD] and absolute [ACD] claudication distances, pressure indices [ABI], popliteal artery flow, and QOL with the short-form 36 Health Survey Questionnaire (SF-36). IPCfoot+calf (120 mm Hg, inflation 4 seconds X 3 impulses per minute, calf inflate delay 1 second) was used for 5 months, greater than or equal to2.5 hours daily. Both groups were advised to exercise unsupervised. Evaluation of patients, after randomization, included the ICD and ACD, ABI, popliteal artery flow with duplex and QOL* at baseline*, 1(/12), 2(/12), 3(/12), 4(/12), 5(/12)*, and 17(/12). Logbooks allowed compliance control. Wilcoxon and Mann-Whitney corrected([Bonferroni]) tests were used. Results: At 5(/12) median ICD, ACD, resting and postexercise ABI had increased by 197%, 212%, 17%, and 64%, respectively, in Group 1 (P < 0.001), but had changed little (P > 0.1) in Group 2; Group 1 had better ICD, ACD, and resting and postexercise ABI (P < 0.01) than Group 2. Inter- and intragroup popliteal flow differences at 5/12 were small (P > 0.1). QOL had improved significantly in Group 1 but not in Group 2; QOL in the former was better (P < 0.01) than in Group 2. QOL in Group 1 was better (P < 0.01) than in Group 2 at 5/12. IPC was complication free. IPC compliance (greater than or equal to2.5 hours/d) was >82% at 1 month and >85% at 3 and 5 months. ABI and walking benefits in Group 1 were maintained a year after cessation of IPC treatment. Conclusions: IPCfoot+calf emerged as an effective, high-compliance, complication-free method for improving the walking ability and pressure indices in stable claudication, with a durable outcome. These changes were associated with a significant improvement in all aspects of QOL evaluated with the SF-36. Despite some limited benefit noted in some individuals, unsupervised exercise had a nonsignificant impact overall.