Peripheral Artery DiseaseMAvERICNCT06114732
Motivating Physical Activity With Behavioural interVention and Electrical Stimulation Remotely in Intermittent Claudication
A study testing Walking exercise behaviour change intervention + TENS in people with Peripheral Artery Disease and Intermittent Claudication, run by Glasgow Caledonian University at 1 site in United Kingdom.
Trial summary
Peripheral Arterial Disease (PAD) is a common vascular disease which commonly causes limb pain and reduced exercise tolerance termed Intermittent Claudication (IC). People with PAD and IC have impaired quality of life, reduced walking ability, and increased mortality compared to those who do not have the condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease, Intermittent Claudication
- What is being tested?
- Walking exercise behaviour change intervention + TENS
- 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 siteUnited Kingdom
- Study dates
- 29 Jan 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Clinical diagnosis of symptomatic Peripheral Arterial Disease (PAD) including resting ABPI <0.9 in at least one leg
- Stable IC for ≥3 months
- Walking limited primarily by claudication
- Able to read and speak English to a level allowing satisfactory completion of the study procedures
- Able to provide written informed consent for participation
Who cannot join
- Planned surgical or endovascular intervention for PAD within the next 3 months
- Critical limb ischaemia
- The presence of any absolute contraindications to exercise testing/training as defined by the American College of Sports Medicine (ACSM)
- Previous experience of using TENS for PAD
- Contraindications to TENS (including epilepsy, dermatological conditions, indwelling electrical pumps/pacemakers) and inability to apply TENS independently.
- Patients who require walking aids including artificial limbs
Show all 10Show fewer
- Major surgery, myocardial infarction or stroke/ TIA in the previous 6 months
- Co-morbidities that cause pain or limit walking to a greater extent than IC (e.g. severe arthritis, respiratory conditions)
- Severe peripheral neuropathies above the ankle.
- Participation in another research protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
NHS Lanarkshire
Glasgow, Lanarkshire, G75 8RG
Sean Paul Carroll, 0141 331 8306, sean.carroll@gcu.ac.uk
Chris Seenan, 0141 331 8151, chris.seenan@gcu.ac.uk
About this study
Official title: Motivating Physical Activity With Behavioural interVention and Electrical Stimulation Remotely in People With Intermittent Claudication (MAvERIC): a Feasibility Randomised Controlled Trial
Peripheral Arterial Disease (PAD) is a common vascular disease which commonly causes limb pain and reduced exercise tolerance termed Intermittent Claudication (IC). People with PAD and IC have impaired quality of life, reduced walking ability, and increased mortality compared to those who do not have the condition.
Improving physical activity (PA) is important in individuals with IC it can improve function, morbidity and mortality rates. While supervised exercise classes are recommended by healthcare authorities they are geographically sparse, and not always accessible due to individuals walking limitations. While home-based exercise can be accessible and improve walking ability, it can be challenging for people with IC to initially plan, conduct, and stay motivated to complete a walking program unsupported, especially when they experience limb pain when walking.
Read more
Investigators have shown that Transcutaneous Electrical Nerve Stimulation (TENS), a non-invasive pain management device, with aims to improve pain and walking distances in patients with IC may be an acceptable modality alongside advice and support from a physiotherapist to overcome these challenges. Investigators have also shown that motivational interviewing, education, and goal-setting with a physiotherapist (physical therapist) has the potential to increase PA, and quality of life.
This study aims to conduct a feasibility trial of four telehealth physiotherapy sessions, alongside the provision of a CE-marked TENS device to reduce limb pain during physical activity. This will be compared to the usual care offered in NHS Lanarkshire
Read the detailed description
Peripheral Arterial Disease (PAD) is a common vascular disease which is symptomatic in 2.4% of 50 to 89 year olds in the UK population. Symptomatic PAD initially presents clinically as limb pain and reduced exercise intolerance termed Intermittent Claudication (IC). Patients with PAD and IC have impaired quality of life due to reduced physical capacity and 3-4 times increased mortality compared to age and sex matched controls.
Improving daily physical activity (PA) is particularly important in individuals with IC as lower PA levels have been recognised as a strong predictor of increased morbidity and mortality in this population. Supervised exercise programs are recommended in clinical guidelines with proven efficacy to help increase physical activity, improve quality of life and contribute to secondary prevention of adverse cardiovascular events (ACVE). Despite this, provision of classes is varied geographically in the UK, and generally is centralised away from rural areas, which may limit uptake and adherence. An alternative to this exercise format may be home-based exercise in the format of a walking-based behaviour change intervention. Home-based exercise for people with intermittent claudication demonstrate a low number of related adverse events, and in the case of walking-based programmes, are likely more accessible, require little equipment, and involve increasing an activity of daily living (ADL) in people with intermittent claudication. Therefore, there is a need for investigation to the acceptability of novel methods of increasing physical activity in a home-based setting.
Lack of self-efficacy, attributed to poor understanding of the disease and uncertainty regarding the importance of exercise, has been shown to be a major barrier to exercise uptake in patients with PAD and IC. Moreover, home based exercise for the self-management of IC is less established in the literature than SEP and there are concerns of low adherence without clinician monitoring. However, if an engaging intervention feasible to the patient and healthcare provider can be established there is potential for greater equality in care, reduced healthcare utilisation and improvement of self-management of PAD in the population.
A proposed intervention to augment walking based physical activity is Transcutaneous electrical nerve stimulation (TENS). TENS a low-cost, non-invasive pain management device with aims to improve pain and walking distances in patients with IC. In our exploratory study we demonstrated that TENS applied to the lower limb during treadmill walking significantly improved pain and increased treadmill walking distances above placebo levels. In addition, Motivating Structured Walking Activity in People with Intermittent Claudication (MOSAIC) is a walking based behavioural intervention utilising motivational interviewing to help people with PAD and IC increase their physical activity. This may help patients plan and overcome barriers to increasing their physical activity by joint clinician and patient set physical activity goals. Both TENS and MOSAIC have potential for remote delivery which could have effects on secondary prevention of ACVE alongside improved function and quality of life for this high-risk group, and ensuring that patients can continue to undertake exercise where it is not feasible to attend SEP, or where fluctuations in social-distancing restrictions occur.
Although TENS and behavioural interventions have been utilised previously in this population to improve physical activity. Neither MOSAIC or TENS have been utilised with aim to improve free living physical activity measured using an accelerometer, and there is a lack of data investigating these outcomes with home based exercise in general. While the author is aware of ongoing works investigating these outcomes, no trial to date has been developed a priori to evaluate the delivery of these treatments remotely in this population.
The primary aim of MAvERIC is to determine the acceptability and feasibility of electrical stimulation via a low-cost CE-marked device, and a remotely delivered walking based behavioural intervention (MOSAIC) in patients with PAD, compared to usual care.
The following research questions will be answered by this project:
- What is the feasibility (i.e. recruitment and retention rates, adherence, safety, sample size for a definitive trial, potential for effectiveness) of conducting a definitive RCT utilising TENS or MOSAIC as an intervention compared to usual care?
- How acceptable is TENS and MOSAIC interventions to patients with IC?
- What are the effects of TENS and MOSAIC as interventions on free living physical activity, pain related, and quality of life PROMs?
- Being tested
- Walking exercise behaviour change intervention + TENS
- Keywords
- Transcutaneous electrical nerve stimulation, Electrical Stimulation, Pain Management, Physiotherapy, Education, Motivational Interviewing, Feasibility
- Medical subject headings
- Peripheral Arterial Disease, Intermittent Claudication, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking exercise behaviour change intervention + TENSBehavioural
MOSAIC: Participants in this group receive two 60-minute individual video telehealth consultations (on weeks one \& two) and two 20-minute follow-up telephone calls (weeks six \& 12) delivered at a convenient time over the internet. All sessions are delivered by a trained senior/band 6 physiotherapist. All participants randomized to this arm are provided with a pedometer and a patient manual which include information on intermittent claudication (IC), risk factors, walking guidelines, goal setting, problem solving and action planning worksheets and a walking diary.
HF-TENS - TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin. Participants will be asked to use TENS during their everyday walking-based tasks, and any planned walking activity they undertake.
| Study group | Role | What they receive |
|---|---|---|
| Walking exercise behaviour change intervention + TENS | Experimental | Participants in the Intervention groups will be asked to attend four telehealth appointments with a physiotherapist. They will also be provided with a TENS machine and training at the baseline appointment on how to use it. They will be instructed to use it daily as their symptoms require for 12 weeks. The device will be set at High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable''). Receives: Behavioral: Walking exercise behaviour change intervention + TENS |
| Usual Care control | No intervention | Usual Care at NHS Lanarkshire Vascular Services and/or Intermittent Claudication service. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rates
Measure recruitment rates (ratio of patients who consent to participate to potentially eligible patient recorded via the study screening log
Measured: End of Study (12 weeks)
Participant retention rate
Ratio of patients who completed the intervention and outcome assessment to the patient who consented
Measured: End of Study (12 weeks)
Adverse events
Record defined adverse events in all groups
Measured: End of Study (12 weeks)
Uptake of interventions
Measure uptake of intervention via log of TENS use and attendance at physiotherapy appointments and follow up phone calls
Measured: End of Study (12 weeks)
Qualitative analysis of participant experience of trial
Analysis of semi-structured discussions with participants regarding experience of trial and interventions
Measured: End of Study (12 weeks)
Theoretical framework of acceptability (TFA) questionnaire
Quantitative measurement of Acceptability of Intervention compared with usual care
Measured: End of Study (12 weeks)
Secondary outcomes (11)
Change in daily physical activity
Total number of steps (activpal step counts)
Measured: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Change in daily physical activity
Upright and sitting events
Measured: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Change in daily physical activity
Walking events
Measured: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Change in daily physical activity
Event-based claudication index (ratio of walking events to upright events) participants undertake in a day
Measured: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Change in daily physical activity
Total duration of walking activity in minutes and seconds
Measured: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Patient Reported Outcome Measure
Disease specific quality of life will be as assessed using the Intermittent Claudication Questionnaire (ICQ).
Measured: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Patient Reported Outcome Measures
Generic quality of life via the EQ-5D-3L
Measured: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Patient Reported Outcome Measures
Pain quality will be recorded using the Short Form McGill Pain Questionnaire (MPQ)
Measured: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Patient Reported Outcome Measures
Average Pain intensity in the past 7 days will be recorded using a Visual Analogue Scale
Measured: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Patient Reported Outcome Measures
Pain self-efficacy via. the Pain Self-Efficacy (PSEQ)
Measured: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Patient Reported Outcome Measures
Pain Catastrophizing via. the Pain Catastrophizing Scale (PCS)
Measured: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start29 Jan 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies 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
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Glasgow Caledonian University
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, St George's, University of London, University of Glasgow, NHS Lanarkshire
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06114732
- Sponsor's protocol ID
- 332468
- Other IDs
- HLS/PSWAHS/22/224
- Acronym
- MAvERIC
- Status last verified
- Aug 2025
- First submitted
- 30 Oct 2023
- Last updated
- 2 Sep 2025
- 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 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivating Physical Activity With Behavioural interVention and Electrical Stimulation Remotely in People With Intermittent Claudication (MAvERIC): a Feasibility Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06114732
- Acronym / sponsor ID
- MAvERIC / 332468
- Keywords
- Transcutaneous electrical nerve stimulation, Electrical Stimulation, Pain Management, Physiotherapy, Education, Motivational Interviewing, Feasibility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Glasgow Caledonian UniversityUniversity, hospital or other
- Collaborators
- King's College London, St George's, University of London, University of Glasgow, NHS Lanarkshire
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 2 Nov 2023 (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.
Peripheral Arterial Disease (PAD) is a common vascular disease which commonly causes limb pain and reduced exercise tolerance termed Intermittent Claudication (IC). People with PAD and IC have impaired quality of life, reduced walking ability, and increased mortality compared to those who do not have the condition.
Improving physical activity (PA) is important in individuals with IC it can improve function, morbidity and mortality rates. While supervised exercise classes are recommended by healthcare authorities they are geographically sparse, and not always accessible due to individuals walking limitations. While home-based exercise can be accessible and improve walking ability, it can be challenging for people with IC to initially plan, conduct, and stay motivated to complete a walking program unsupported, especially when they experience limb pain when walking.
Investigators have shown that Transcutaneous Electrical Nerve Stimulation (TENS), a non-invasive pain management device, with aims to improve pain and walking distances in patients with IC may be an acceptable modality alongside advice and support from a physiotherapist to overcome these challenges. Investigators have also shown that motivational interviewing, education, and goal-setting with a physiotherapist (physical therapist) has the potential to increase PA, and quality of life.
This study aims to conduct a feasibility trial of four telehealth physiotherapy sessions, alongside the provision of a CE-marked TENS device to reduce limb pain during physical activity. This will be compared to the usual care offered in NHS Lanarkshire
Detailed description
Peripheral Arterial Disease (PAD) is a common vascular disease which is symptomatic in 2.4% of 50 to 89 year olds in the UK population. Symptomatic PAD initially presents clinically as limb pain and reduced exercise intolerance termed Intermittent Claudication (IC). Patients with PAD and IC have impaired quality of life due to reduced physical capacity and 3-4 times increased mortality compared to age and sex matched controls.
Improving daily physical activity (PA) is particularly important in individuals with IC as lower PA levels have been recognised as a strong predictor of increased morbidity and mortality in this population. Supervised exercise programs are recommended in clinical guidelines with proven efficacy to help increase physical activity, improve quality of life and contribute to secondary prevention of adverse cardiovascular events (ACVE). Despite this, provision of classes is varied geographically in the UK, and generally is centralised away from rural areas, which may limit uptake and adherence. An alternative to this exercise format may be home-based exercise in the format of a walking-based behaviour change intervention. Home-based exercise for people with intermittent claudication demonstrate a low number of related adverse events, and in the case of walking-based programmes, are likely more accessible, require little equipment, and involve increasing an activity of daily living (ADL) in people with intermittent claudication. Therefore, there is a need for investigation to the acceptability of novel methods of increasing physical activity in a home-based setting.
Lack of self-efficacy, attributed to poor understanding of the disease and uncertainty regarding the importance of exercise, has been shown to be a major barrier to exercise uptake in patients with PAD and IC. Moreover, home based exercise for the self-management of IC is less established in the literature than SEP and there are concerns of low adherence without clinician monitoring. However, if an engaging intervention feasible to the patient and healthcare provider can be established there is potential for greater equality in care, reduced healthcare utilisation and improvement of self-management of PAD in the population.
A proposed intervention to augment walking based physical activity is Transcutaneous electrical nerve stimulation (TENS). TENS a low-cost, non-invasive pain management device with aims to improve pain and walking distances in patients with IC. In our exploratory study we demonstrated that TENS applied to the lower limb during treadmill walking significantly improved pain and increased treadmill walking distances above placebo levels. In addition, Motivating Structured Walking Activity in People with Intermittent Claudication (MOSAIC) is a walking based behavioural intervention utilising motivational interviewing to help people with PAD and IC increase their physical activity. This may help patients plan and overcome barriers to increasing their physical activity by joint clinician and patient set physical activity goals. Both TENS and MOSAIC have potential for remote delivery which could have effects on secondary prevention of ACVE alongside improved function and quality of life for this high-risk group, and ensuring that patients can continue to undertake exercise where it is not feasible to attend SEP, or where fluctuations in social-distancing restrictions occur.
Although TENS and behavioural interventions have been utilised previously in this population to improve physical activity. Neither MOSAIC or TENS have been utilised with aim to improve free living physical activity measured using an accelerometer, and there is a lack of data investigating these outcomes with home based exercise in general. While the author is aware of ongoing works investigating these outcomes, no trial to date has been developed a priori to evaluate the delivery of these treatments remotely in this population.
The primary aim of MAvERIC is to determine the acceptability and feasibility of electrical stimulation via a low-cost CE-marked device, and a remotely delivered walking based behavioural intervention (MOSAIC) in patients with PAD, compared to usual care.
The following research questions will be answered by this project:
- What is the feasibility (i.e. recruitment and retention rates, adherence, safety, sample size for a definitive trial, potential for effectiveness) of conducting a definitive RCT utilising TENS or MOSAIC as an intervention compared to usual care?
- How acceptable is TENS and MOSAIC interventions to patients with IC?
- What are the effects of TENS and MOSAIC as interventions on free living physical activity, pain related, and quality of life PROMs?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Walking exercise behaviour change intervention + TENS | Experimental | Behavioral: Walking exercise behaviour change intervention + TENSParticipants in the Intervention groups will be asked to attend four telehealth appointments with a physiotherapist. They will also be provided with a TENS machine and training at the baseline appointment on how to use it. They will be instructed to use it daily as their symptoms require for 12 weeks. The device will be set at High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable''). |
| Usual Care control | No intervention | –Usual Care at NHS Lanarkshire Vascular Services and/or Intermittent Claudication service. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of symptomatic Peripheral Arterial Disease (PAD) including resting ABPI <0.9 in at least one leg
- Stable IC for ≥3 months
- Walking limited primarily by claudication
- Able to read and speak English to a level allowing satisfactory completion of the study procedures
- Able to provide written informed consent for participation
Key exclusion criteria (10 listed)
- Planned surgical or endovascular intervention for PAD within the next 3 months
- Critical limb ischaemia
- The presence of any absolute contraindications to exercise testing/training as defined by the American College of Sports Medicine (ACSM)
- Previous experience of using TENS for PAD
- Contraindications to TENS (including epilepsy, dermatological conditions, indwelling electrical pumps/pacemakers) and inability to apply TENS independently.
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 |
|---|---|---|
| Walking exercise behaviour change intervention + TENSMOSAIC: Participants in this group receive two 60-minute individual video telehealth consultations (on weeks one \& two) and two 20-minute follow-up telephone calls (weeks six \& 12) delivered at a convenient time over the internet. All sessions are delivered by a trained senior/band 6 physiotherapist. All participants randomized to this arm are provided with a pedometer and a patient manual which include information on intermittent claudication (IC), risk factors, walking guidelines, goal setting, problem solving and action planning worksheets and a walking diary. HF-TENS - TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin. Participants will be asked to use TENS during their everyday walking-based tasks, and any planned walking activity they undertake. | Behavioural | Walking exercise behaviour change intervention + TENS |
Primary outcome
Recruitment rates
Time frame: End of Study (12 weeks)
Measure recruitment rates (ratio of patients who consent to participate to potentially eligible patient recorded via the study screening log
Participant retention rate
Time frame: End of Study (12 weeks)
Ratio of patients who completed the intervention and outcome assessment to the patient who consented
Adverse events
Time frame: End of Study (12 weeks)
Record defined adverse events in all groups
Uptake of interventions
Time frame: End of Study (12 weeks)
Measure uptake of intervention via log of TENS use and attendance at physiotherapy appointments and follow up phone calls
Qualitative analysis of participant experience of trial
Time frame: End of Study (12 weeks)
Analysis of semi-structured discussions with participants regarding experience of trial and interventions
Theoretical framework of acceptability (TFA) questionnaire
Time frame: End of Study (12 weeks)
Quantitative measurement of Acceptability of Intervention compared with usual care
11 secondary outcomes
Change in daily physical activity
Time frame: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Change in daily physical activity
Time frame: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Change in daily physical activity
Time frame: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Change in daily physical activity
Time frame: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Change in daily physical activity
Time frame: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Patient Reported Outcome Measure
Time frame: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Patient Reported Outcome Measures
Time frame: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Patient Reported Outcome Measures
Time frame: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Patient Reported Outcome Measures
Time frame: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Patient Reported Outcome Measures
Time frame: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Patient Reported Outcome Measures
Time frame: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking exercise behaviour change intervention + TENS in people with Peripheral Artery Disease and Intermittent Claudication, run by Glasgow Caledonian University at 1 site in United Kingdom.
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 5 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 2 Sep 2025. 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 United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sean Paul Carroll, PhDCandidate (+44 (0)141 331 8306, sean.carroll@gcu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates (time frame: End of Study (12 weeks)). The study lists 6 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 2 Sep 2025.