Behavioural intervention and TENS for Intermittent Claudication V1
Research type
Research Study
Full title
Motivating physical Activity with behavioural intervention and electrical stimulation remotely in people with Intermittent Claudication (MAveRIC): a Feasibility Randomised Controlled Trial
IRAS ID
332468
Contact name
Chris Seenan
Contact email
Sponsor organisation
Glasgow Caledonian University
Duration of Study in the UK
1 years, 5 months, 30 days
Research 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. 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.
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. We aim to recruit adults with IC from NHS Lanarkshire Vascular Service. The intervention will last 6 weeks and we aim to follow up all participants for to 12-months. Participants will be asked to complete questionnaires and wear a small physical activity monitor for a one-week period at five points over this period. No change will be made to usual care except the additional telehealth physiotherapy sessions and provision of a CE-marked TENS device for the intervention group.REC name
West of Scotland REC 5
REC reference
23/WS/0147
Date of REC Opinion
30 Oct 2023
REC opinion
Further Information Favourable Opinion