Status:
RECRUITING
Motivating Physical Activity With Behavioural interVention and Electrical Stimulation Remotely in Intermittent Claudication
Lead Sponsor:
Glasgow Caledonian University
Collaborating Sponsors:
King's College London
St George's, University of London
Conditions:
Peripheral Artery Disease
Intermittent Claudication
Eligibility:
All Genders
18+ years
Phase:
NA
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 impaire...
Detailed Description
Peripheral Arterial Disease (PAD) is a common vascular disease which is symptomatic in 2.4% of 50 to 89 year olds in the UK population. Symptomatic PAD initially presents clinically as limb pain and r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06114732
Start Date
January 29 2024
End Date
December 1 2026
Last Update
September 2 2025
Active Locations (1)
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1
NHS Lanarkshire
Glasgow, Lanarkshire, United Kingdom, G75 8RG