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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGlasgow Caledonian University

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Walking exercise behaviour change intervention + TENS

Treatment groups

48 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Glasgow Caledonian University

Lead sponsor

King's College London

Collaborator

St George's, University of London

Collaborator

University of Glasgow

Collaborator

NHS Lanarkshire

Collaborator