NIPH Clinical Trials Search

Efficacy of Neuromuscular Electrical Stimulation Combined With Heparin-Augmented Exercise Therapy in Patients With Peripheral Artery Disease

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Lower extremity arterial disease associated with intermittent claudication
Date of first enrollment	05/08/2025
Target sample size	28
Countries of recruitment
Study type	Interventional
Intervention(s)	In the intervention group, neuromuscular electrical stimulation (NMES) will be applied to both lower limbs using the Belt Electrode-Skeletal Muscle Electrical Stimulation (B-SES) system at a high intensity of 20 Hz for 10 minutes. As standard therapy, both groups will receive intravenous administration of 3,000 units of heparin followed by 40 minutes of walking exercise, performed twice daily for 14 consecutive days.

Outcome(s)

Primary Outcome	Change from baseline in maximal walking time (or distance) on the modified Gardner TM test after 14-day treatment.
Secondary Outcome	Changes from baseline in claudication onset time (or walking distance) at 15 days and at 12 weeks; change from baseline in maximal walking time (or distance) at 12 weeks; and changes from baseline in ankle-brachial index (ABI) at 15 days and at 12 weeks.

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 85age old
Gender	Both
Include criteria	(1) Patients who received a rehabilitation prescription from a physician as part of the clinical management of peripheral arterial disease (PAD) at Dokkyo Medical University Nikko Medical Center. (2) Patients classified as Fontaine stage II, with an ankle-brachial index (ABI) of 0.90 or less than 0.90 within the past 6 months, or with an ABI a decrease to less than 0.90 after 1 minute of ankle flexion and extension exercises. (3) Patients whose maximal walking time was 60 seconds or longer than 60 seconds and < 840 seconds in a modified Gardner treadmill test conducted in advance as part of routine clinical care. (4) Patients aged 18 to 85 years at the time of consent. (5) Patients who provided written informed consent to participate in the study.
Exclude criteria	(1) Patients with intermittent claudication caused by conditions other than peripheral arterial disease (PAD). (2) Patients with critical limb ischemia presenting with ulcers or rest pain (excluded due to potential impact on safety evaluation). (3) Patients with contraindications to neuromuscular electrical stimulation, such as those with implanted devices like pacemakers (excluded based on risk-benefit considerations). (4) Patients with unstable angina, acute myocardial infarction, or stroke within the past 3 months. (5) Patients with malignancies or suspected malignancies, and those with proliferative diabetic retinopathy (as angiogenic therapy may be contraindicated). (6) Patients deemed inappropriate for study participation by the attending physician.