Peripheral Arterial Disease(PAD), Peripheral Arterial Disease, Peripheral Arterial Diseases, Intermittent Claudicants
Conditions
Keywords
Neuromuscular Electrical Stimulation, NMES
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.
Interventions
BEHAVIORALNMES
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.
BEHAVIORALOMT
Participants received OMT according to current PAD guidelines and the recommendations of their treating physicians.
Sponsors
Halic University
Fatih Sultan Mehmet Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking capacity | Baseline and 6 weeks (post-intervention) | 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. |
| PAD severity | Baseline and 6 weeks (post-intervention) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain level | Baseline and 6 weeks (post-intervention) | 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. |
| Fatigue level | Baseline and 6 weeks (post-intervention) | 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. |
| Generic quality of life | Baseline and 6 weeks (post-intervention) | 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. |
| Disease-specific quality of life | Baseline and 6 weeks (post-intervention) | 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. |
Countries
Turkey (Türkiye)
Contacts
PRINCIPAL_INVESTIGATORÖzlem Erodabaşı, Asst. Prof.
Haliç University
Outcome results
None listed