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

Launched by GLASGOW CALEDONIAN UNIVERSITY · Oct 30, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at ways to help people with Peripheral Artery Disease (PAD), specifically those who experience leg pain when walking, a condition known as Intermittent Claudication (IC). The study aims to see if providing support through remote physiotherapy sessions and a device called Transcutaneous Electrical Nerve Stimulation (TENS), which helps manage pain, can encourage more physical activity at home. Being more active can improve walking ability and overall quality of life for those with IC.

To participate in this trial, individuals need to be diagnosed with PAD and have had stable IC for at least three months. They should be able to read and speak English well enough to follow study instructions and must be able to give written consent. Participants can expect to take part in four online physiotherapy sessions, where they will receive guidance and support while using the TENS device to help reduce their leg pain. It's important to note that certain medical conditions or treatments may prevent someone from joining the study, such as recent surgeries or severe pain from other health issues.

Gender

ALL

Eligibility criteria

• 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