NCT06114732 Motivating Physical Activity With Behavioural interVention and Electrical Stimulation Remotely in Intermittent Claudication

Eligibility & Interventions

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This trial targets 48 participants in total. It began in 2024-01-29 with a primary completion date of 2026-07-01.

Brief 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. 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

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

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