An interventional study of NMES and OMT in Peripheral Arterial Disease(PAD), Peripheral Arterial Disease and Peripheral Arterial Diseases, sponsored by Halic University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by Halic University · Not applicable, Interventional, and Treatment
This randomized controlled trial investigated the effects of neuromuscular electrical stimulation (NMES), in addition to optimal medical therapy (OMT), on walking capacity, pain, fatigue, and quality of life in individuals with intermittent claudication due to peripheral arterial disease (PAD). A total of 48 participants were randomly allocated to either the NMES or control group. Participants in the NMES group received NMES for 40 minutes per session, three times per week, for six weeks, in addition to OMT, whereas the control group received OMT alone. Outcome measures included walking capacity, pain, fatigue, disease-specific and generic quality of life, and ankle-brachial index (ABI). Assessments were performed at baseline and after the 6-week intervention.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 48 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
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Exclusion Criteria:
Behavioral: NMES · Behavioral: OMT
Behavioral: OMT
NMES was applied bilaterally to the tibialis anterior and gastrocnemius muscles using a four-channel portable stimulator. Stimulation was delivered with a symmetrical biphasic waveform at 35-50 Hz, a pulse duration of 300-400 μs, and a duty cycle of 10 seconds on and 20 seconds off. Each session lasted 40 minutes and was administered three times per week for six weeks (18 sessions) under physiotherapist supervision. Stimulation intensity was individually adjusted to produce visible, rhythmic muscle contractions without voluntary muscle activation.
Participants received OMT according to current PAD guidelines and the recommendations of their treating physicians.
Walking capacity
Walking capacity was assessed using the 6-Minute Walk Test (6MWT) in accordance with the American Thoracic Society guidelines. Participants were instructed to walk as far as possible along a flat corridor for six minutes, and the total distance walked was recorded in meters (m). The 6MWT is a performance-based measure with no predefined minimum or maximum score; greater walking distance indicates better functional walking capacity.
Time frame: Baseline and 6 weeks (post-intervention)
PAD severity
PAD severity was assessed using the ankle-brachial index (ABI), a non-invasive measure of lower-extremity arterial perfusion. ABI was calculated as the ratio of the highest ankle systolic blood pressure to the highest brachial systolic blood pressure.
Time frame: Baseline and 6 weeks (post-intervention)
Pain level
Pain was assessed using the Visual Analog Scale (VAS). The scale consists of a 10-cm horizontal line anchored by 'no pain' (0) at one end and 'the worst pain' (10) at the other. Participants were asked to indicate the level of pain they were experiencing.
Time frame: Baseline and 6 weeks (post-intervention)
Fatigue level
Fatigue level was assessed using the Modified Borg Scale (mBorg). The scale rates perceived exertion from 0 (no exertion at all) to 10 (maximal exertion), with higher scores indicating greater perceived fatigue.
Time frame: Baseline and 6 weeks (post-intervention)
Generic quality of life
Generic quality of life was assessed using the Short Form-36 (SF-36). Participants' responses were scored in accordance with the scale instructions, and standard scores ranging from 0 to 100 were calculated for each subscale. Higher scores indicate a better health-related quality of life.
Time frame: Baseline and 6 weeks (post-intervention)
Disease-specific quality of life
Disease-specific quality of life was assessed using the Vascular Quality of Life Questionnaire-6 (VascuQoL-6) Short Form. Each item is rated on a 5-point Likert scale (1=Not at all/Very good, 5=Always/Very poor). The total score ranges from 6 to 30, with lower scores indicating better disease-specific quality of life and higher scores indicating poorer disease-specific quality of life.
Time frame: Baseline and 6 weeks (post-intervention)
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Halic University