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
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
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
Parallel
Walking exercise behaviour change intervention + TENS
BehavioralMOSAIC: 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.
Recruitment rates
Measure recruitment rates (ratio of patients who consent to participate to potentially eligible patient recorded via the study screening log
Participant retention rate
Ratio of patients who completed the intervention and outcome assessment to the patient who consented
Adverse events
Record defined adverse events in all groups
Uptake of interventions
Measure uptake of intervention via log of TENS use and attendance at physiotherapy appointments and follow up phone calls
Change in daily physical activity
Total number of steps (activpal step counts)
Change in daily physical activity
Upright and sitting events
Change in daily physical activity
Walking events
Change in daily physical activity
Event-based claudication index (ratio of walking events to upright events) participants undertake in a day
Evaluation and monitoring of intervention fidelity
This will be assessed by a member of the study team with reference to the MOSAIC materials and therapist training manual.
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Glasgow Caledonian University
Lead sponsor
King's College London
Collaborator
St George's, University of London
Collaborator
University of Glasgow
Collaborator
NHS Lanarkshire
Collaborator
