An interventional study of Walking exercise behaviour change intervention + TENS in Peripheral Artery Disease and Intermittent Claudication, sponsored by Glasgow Caledonian University. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-02.
Sponsored by Glasgow Caledonian University · Not applicable, Interventional, and Treatment
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
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:
309 studies on the registry are indexed under Intermittent Claudication; 46 are open to participants now.
This study's planned enrollment of 48 is below the median of 74 across 242 interventional studies indexed under Intermittent Claudication.
Browse Intermittent Claudication studies →Glasgow Caledonian University is the lead sponsor of 46 studies on the registry; 3 are open to participants now.
Compared within Intermittent Claudication, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Peripheral Arterial Disease. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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'').
Behavioral: Walking exercise behaviour change intervention + TENS
Usual Care at NHS Lanarkshire Vascular Services and/or Intermittent Claudication service.
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.
Recruitment rates
Measure recruitment rates (ratio of patients who consent to participate to potentially eligible patient recorded via the study screening log
Time frame: End of Study (12 weeks)
Participant retention rate
Ratio of patients who completed the intervention and outcome assessment to the patient who consented
Time frame: End of Study (12 weeks)
Adverse events
Record defined adverse events in all groups
Time frame: 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
Time frame: 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
Time frame: End of Study (12 weeks)
Theoretical framework of acceptability (TFA) questionnaire
Quantitative measurement of Acceptability of Intervention compared with usual care
Time frame: End of Study (12 weeks)
Change in daily physical activity
Total number of steps (activpal step counts)
Time frame: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Change in daily physical activity
Upright and sitting events
Time frame: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Change in daily physical activity
Walking events
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)
Evaluation and monitoring of intervention fidelity
This will be assessed by a member of the study team with reference to the MOSAIC materials and therapist training manual.
Time frame: End of Study (12 weeks)
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Jul 2026, 29 months after the start.
Of 73 non-industry interventional studies with no phase under Intermittent Claudication, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 77. This study's planned 29 months is below that.
Counting every sponsor, half of 84 studies reached it within 41 months; a quarter within 17 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
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Glasgow Caledonian University