[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524899":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":34,"responsibleParty":60,"collaborators":62,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":18,"enrollmentInfo":81,"targetDuration":18,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Glasgow Caledonian University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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'').",[13],"Behavioral: Walking exercise behaviour change intervention + TENS",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care control","NO_INTERVENTION","Usual Care at NHS Lanarkshire Vascular Services and\u002For Intermittent Claudication service.",null,[20],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":18},"BEHAVIORAL","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\u002Fband 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.\n\nHF-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.",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Sean Paul Carroll, PhDCandidate","CONTACT","+44 (0)141 331 8306","sean.carroll@gcu.ac.uk",{"name":31,"role":27,"phone":32,"phoneExt":18,"email":33},"Chris Seenan, PhD","+44 (0)141 331 8151","chris.seenan@gcu.ac.uk",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"NHS Lanarkshire","RECRUITING","Glasgow","Lanarkshire","G75 8RG","United Kingdom","UK",{"type":44,"coordinates":45},"Point",[46,47],-4.25763,55.86515,{"lat":47,"lon":46},[50,53,56,59],{"name":51,"role":27,"phone":52,"phoneExt":18,"email":29},"Sean Paul Carroll","0141 331 8306",{"name":54,"role":27,"phone":55,"phoneExt":18,"email":33},"Chris Seenan","0141 331 8151",{"name":57,"role":58,"phone":18,"phoneExt":18,"email":18},"Sean Paul Carroll, PhD Candidate","PRINCIPAL_INVESTIGATOR",{"name":31,"role":58,"phone":18,"phoneExt":18,"email":18},{"type":61,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[63,65,67,69],{"name":64,"class":6},"King's College London",{"name":66,"class":6},"St George's, University of London",{"name":68,"class":6},"University of Glasgow",{"name":36,"class":70},"OTHER_GOV","100524899","motivating-physical-activity-with-behavioural-intervention-and-electrical-stimulation-remotely-in-intermittent-claudication-100524899",false,"NCT06114732","Motivating Physical Activity With Behavioural interVention and Electrical Stimulation Remotely in Intermittent Claudication","Motivating Physical Activity With Behavioural interVention and Electrical Stimulation Remotely in People With Intermittent Claudication (MAvERIC): a Feasibility Randomised Controlled Trial","MAvERIC","Inclusion Criteria:\n\n* Clinical diagnosis of symptomatic Peripheral Arterial Disease (PAD) including resting ABPI \\\u003C0.9 in at least one leg\n* Stable IC for ≥3 months\n* Walking limited primarily by claudication\n* Able to read and speak English to a level allowing satisfactory completion of the study procedures\n* Able to provide written informed consent for participation\n\nExclusion Criteria:\n\n* Planned surgical or endovascular intervention for PAD within the next 3 months\n* Critical limb ischaemia\n* The presence of any absolute contraindications to exercise testing\u002Ftraining as defined by the American College of Sports Medicine (ACSM)\n* Previous experience of using TENS for PAD\n* Contraindications to TENS (including epilepsy, dermatological conditions, indwelling electrical pumps\u002Fpacemakers) and inability to apply TENS independently.\n* Patients who require walking aids including artificial limbs\n* Major surgery, myocardial infarction or stroke\u002F TIA in the previous 6 months\n* Co-morbidities that cause pain or limit walking to a greater extent than IC (e.g. severe arthritis, respiratory conditions)\n* Severe peripheral neuropathies above the ankle.\n* Participation in another research protocol","ALL","18 Years",{"count":82,"type":83},48,"ESTIMATED","INTERVENTIONAL",[86],"NA","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.\n\nImproving 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.\n\nInvestigators 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.\n\nThis 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",[89,90],"Peripheral Artery Disease","Intermittent Claudication",[92,93,94,95,96,97,98],"Transcutaneous electrical nerve stimulation","Electrical Stimulation","Pain Management","Physiotherapy","Education","Motivational Interviewing","Feasibility","2025-08-25",{"date":101,"type":102},"2025-09-02","ACTUAL",{"date":104,"type":102},"2024-01-29",{"date":106,"type":83},"2026-12-01",{"name":5,"class":6},1]