Neuromuscular Electrical Stimulation in Peripheral Arterial Disease

NCT07851766 | Completed

• 1 other identifier: 2025/18/1232
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peripheral Arterial Disease(PAD); Intermittent Claudicants; Peripheral Arterial Disease; Peripheral Arterial Diseases

Keywords

Neuromuscular Electrical Stimulation; NMES

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 6 weeks (post-intervention)

Secondary Outcomes (4)

• Pain level

  Baseline and 6 weeks (post-intervention)

• Fatigue level

  Baseline and 6 weeks (post-intervention)

• Generic quality of life

  Baseline and 6 weeks (post-intervention)

• Disease-specific quality of life

  Baseline and 6 weeks (post-intervention)

Study Arms (2)

NMES + OMT

EXPERIMENTAL

Behavioral: NMES; Behavioral: OMT

OMT

OTHER

Behavioral: OMT

Interventions

NMES BEHAVIORAL

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.

NMES + OMT

OMT BEHAVIORAL

Participants received OMT according to current PAD guidelines and the recommendations of their treating physicians.

NMES + OMT; OMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged ≥18 years with a diagnosis of PAD
• An ABI ≤0.90
• Diagnosis of PAD for at least 6 months with persistent symptoms
• Presence of intermittent claudication
• Ability to walk independently and complete the study assessments
• Provision of written informed consent

You may not qualify if:

• Presence of a cardiac pacemaker or metallic implant
• Inability to walk due to severe musculoskeletal or neurological disorders
• Severe pulmonary disease
• Open wounds or impaired skin integrity at the electrode application sites
• Cognitive impairment that precluded completion of the study questionnaires or provision of reliable responses

Sponsors & Collaborators

• Halic University: lead
• Fatih Sultan Mehmet Training and Research Hospital: collaborator

Study Sites (1)

Haliç University

Istanbul, Eyüpsultan, 34060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Özlem Erodabaşı, Asst. Prof.

  Haliç University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: October 1, 2026
• Study Start: October 1, 2025
• Primary Completion: January 10, 2026
• Study Completion: January 10, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)