Motivating Physical Activity With Behavioural interVention and Electrical Stimulation Remotely in People With Intermittent Claudication (MAvERIC): a Feasibility Randomised Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
NHS Lanarkshire
RECRUITING
Glasgow
Contact Information
Primary
Sean Paul Carroll, PhDCandidate
sean.carroll@gcu.ac.uk
+44 (0)141 331 8306
Backup
Chris Seenan, PhD
chris.seenan@gcu.ac.uk
+44 (0)141 331 8151
Time Frame
Start Date: 2024-01-29
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 48
Treatments
Experimental: Walking exercise behaviour change intervention + TENS
Participants in the Intervention groups will be asked to attend four telehealth appointments with a physiotherapist. They will also be provided with a TENS machine and training at the baseline appointment on how to use it. They will be instructed to use it daily as their symptoms require for 12 weeks. The device will be set at High Frequency-TENS (120 Hz, 200µs and a patient-determined intensity of ''strong but comfortable'').
No_intervention: Usual Care control
Usual Care at NHS Lanarkshire Vascular Services and/or Intermittent Claudication service.
Sponsors
Leads: Glasgow Caledonian University
Collaborators: NHS Lanarkshire, St George's, University of London, University of Glasgow, King's College London

This content was sourced from clinicaltrials.gov