Peripheral Arterial Disease(PAD)NCT07851766
Neuromuscular Electrical Stimulation in Peripheral Arterial Disease
A study testing NMES and OMT in people with Peripheral Arterial Disease(PAD) and Peripheral Arterial Disease, run by Halic University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease(PAD), Peripheral Arterial Disease, Peripheral Arterial Diseases
- What is being tested?
- NMES and OMT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2025to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Neuromuscular Electrical Stimulation on Walking Capacity, Pain, Fatigue, and Quality of Life in Individuals With Intermittent Claudication Due to Peripheral Arterial Disease
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), Peripheral Arterial Disease, Peripheral Arterial Diseases, Intermittent Claudicants
- Being tested
- NMES, OMT
- Keywords
- Neuromuscular Electrical Stimulation, NMES
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMESBehavioural
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.
OMTBehavioural
Participants received OMT according to current PAD guidelines and the recommendations of their treating physicians.
| Study group | Role | What they receive |
|---|---|---|
| NMES + OMT | Experimental | Not described Receives: Behavioral: NMES; Behavioral: OMT |
| OMT | Other | Not described Receives: Behavioral: OMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and 6 weeks (post-intervention)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and 6 weeks (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Oct 2025
- Primary completion10 Jan 2026
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Disease(PAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halic University
- Sponsor type
- University, hospital or other
- Collaborators
- Fatih Sultan Mehmet Training and Research Hospital
- Responsible party
- Sponsor
- Investigators
- Özlem Erodabaşı, Asst. Prof., Principal investigator, Haliç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07851766
- Sponsor's protocol ID
- 2025/18/1232
- Status last verified
- Sep 2026
- First submitted
- 23 Jul 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Neuromuscular Electrical Stimulation on Walking Capacity, Pain, Fatigue, and Quality of Life in Individuals With Intermittent Claudication Due to Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT07851766
- Acronym / sponsor ID
- 2025/18/1232
- Conditions
- Peripheral Arterial Disease(PAD), Peripheral Arterial Disease, Peripheral Arterial Diseases, Intermittent Claudicants
- Keywords
- Neuromuscular Electrical Stimulation, NMES
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Halic UniversityUniversity, hospital or other
- Collaborators
- Fatih Sultan Mehmet Training and Research Hospital
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NMES + OMT | Experimental | Behavioral: NMES, Behavioral: OMT |
| OMT | Other | Behavioral: OMT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMESNMES 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. | Behavioural | NMES + OMT |
| OMTParticipants received OMT according to current PAD guidelines and the recommendations of their treating physicians. | Behavioural | NMES + OMT, OMT |
Primary outcome
Walking capacity
Time frame: 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
Time frame: 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.
4 secondary outcomes
Pain level
Time frame: Baseline and 6 weeks (post-intervention)
Fatigue level
Time frame: Baseline and 6 weeks (post-intervention)
Generic quality of life
Time frame: Baseline and 6 weeks (post-intervention)
Disease-specific quality of life
Time frame: Baseline and 6 weeks (post-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Özlem Erodabaşı, Asst. Prof. principal investigator
Haliç University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMES and OMT in people with Peripheral Arterial Disease(PAD) and Peripheral Arterial Disease, run by Halic University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking capacity (time frame: Baseline and 6 weeks (post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.