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Motivating Physical Activity With Behavioural interVention and Electrical Stimulation Remotely in Intermittent Claudication
Sponsor: Glasgow Caledonian University
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
Official title: Motivating Physical Activity With Behavioural interVention and Electrical Stimulation Remotely in People With Intermittent Claudication (MAvERIC): a Feasibility Randomised Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2024-01-29
Completion Date
2026-12-01
Last Updated
2025-09-02
Healthy Volunteers
No
Interventions
Walking exercise behaviour change intervention + TENS
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.
Locations (1)
NHS Lanarkshire
Glasgow, Lanarkshire, United Kingdom