Improving physical activity in patients with Peripheral Artery Disease using electrical stimulation and behavior change

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to enhance physical activity in individuals suffering from Peripheral Artery Disease (PAD) and Intermittent Claudication (IC) through a combination of a walking exercise behavior change intervention and Transcutaneous Electrical Nerve Stimulation (TENS). The approach addresses the challenges faced by patients in accessing supervised exercise programs, particularly in rural areas, by providing a home-based solution that encourages walking despite pain. Participants will be monitored and supported to ensure adherence to the program, which is designed to improve their quality of life and reduce the risks associated with low physical activity levels.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• NHS Lanarkshire
  Glasgow, Lanarkshire, United Kingdom Recruiting

Study contacts

• Study coordinator: Sean Paul Carroll, PhDCandidate
• Email: sean.carroll@gcu.ac.uk
• Phone: +44 (0)141 331 8306

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.