Improving physical activity in patients with Peripheral Artery Disease using electrical stimulation and behavior change
Motivating Physical Activity With Behavioural interVention and Electrical Stimulation Remotely in People With Intermittent Claudication (MAvERIC): a Feasibility Randomised Controlled Trial
NA · Glasgow Caledonian University · NCT06114732
This study is testing whether a combination of walking exercises and electrical stimulation can help people with Peripheral Artery Disease be more active and improve their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Glasgow Caledonian University (other) |
| Locations | 1 site (Glasgow, Lanarkshire) |
| Trial ID | NCT06114732 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with symptomatic Peripheral Artery Disease who experience stable Intermittent Claudication and have limited walking ability due to claudication pain.
Not a fit: Patients who have critical limb ischemia or those requiring walking aids, such as artificial limbs, are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the walking ability and overall quality of life for patients with Peripheral Artery Disease.
How similar studies have performed: Other studies have shown promise in using home-based exercise interventions for similar conditions, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Glasgow, Lanarkshire
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Peripheral Artery Disease, Intermittent Claudication, Transcutaneous electrical nerve stimulation, Electrical Stimulation, Pain Management, Physiotherapy, Education, Motivational Interviewing