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

NCT06114732 | Recruiting

• 2 other identifiers: 332468HLS/PSWAHS/22/224
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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 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

Conditions

Peripheral Artery Disease; Intermittent Claudication

Keywords

Transcutaneous electrical nerve stimulation; Electrical Stimulation; Pain Management; Physiotherapy; Education; Motivational Interviewing; Feasibility

Outcome Measures

Primary Outcomes (6)

• Recruitment rates

  Measure recruitment rates (ratio of patients who consent to participate to potentially eligible patient recorded via the study screening log

  End of Study (12 weeks)

• Participant retention rate

  Ratio of patients who completed the intervention and outcome assessment to the patient who consented

  End of Study (12 weeks)

• Adverse events

  Record defined adverse events in all groups

  End of Study (12 weeks)

• Uptake of interventions

  Measure uptake of intervention via log of TENS use and attendance at physiotherapy appointments and follow up phone calls

  End of Study (12 weeks)

• Qualitative analysis of participant experience of trial

  Analysis of semi-structured discussions with participants regarding experience of trial and interventions

  End of Study (12 weeks)

• Theoretical framework of acceptability (TFA) questionnaire

  Quantitative measurement of Acceptability of Intervention compared with usual care

  End of Study (12 weeks)

Secondary Outcomes (11)

• Change in daily physical activity

  Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)

• Change in daily physical activity

  Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)

• Change in daily physical activity

  Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)

• Change in daily physical activity

  Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)

• Change in daily physical activity

  Baseline, 6 weeks, 12 weeks, 6 months (follow up), and 12 months (follow up)

Other Outcomes (1)

• Evaluation and monitoring of intervention fidelity

  End of Study (12 weeks)

Study Arms (2)

Walking exercise behaviour change intervention + TENS

EXPERIMENTAL

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'').

Behavioral: Walking exercise behaviour change intervention + TENS

Usual Care control

NO INTERVENTION

Usual Care at NHS Lanarkshire Vascular Services and/or Intermittent Claudication service.

Interventions

Walking exercise behaviour change intervention + TENS BEHAVIORAL

MOSAIC: Participants in this group receive two 60-minute individual video telehealth consultations (on weeks one \& two) and two 20-minute follow-up telephone calls (weeks six \& 12) delivered at a convenient time over the internet. All sessions are delivered by a trained senior/band 6 physiotherapist. All participants randomized to this arm are provided with a pedometer and a patient manual which include information on intermittent claudication (IC), risk factors, walking guidelines, goal setting, problem solving and action planning worksheets and a walking diary. HF-TENS - TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin. Participants will be asked to use TENS during their everyday walking-based tasks, and any planned walking activity they undertake.

Walking exercise behaviour change intervention + TENS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Glasgow Caledonian University: lead
• King's College London: collaborator
• St George's, University of London: collaborator
• University of Glasgow: collaborator
• NHS Lanarkshire: collaborator

Study Sites (1)

NHS Lanarkshire

Glasgow, Lanarkshire, G75 8RG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication; Agnosia

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Sean Paul Carroll, PhDCandidate

CONTACT

+44 (0)141 331 8306; sean.carroll@gcu.ac.uk

Chris Seenan, PhD

CONTACT

+44 (0)141 331 8151; chris.seenan@gcu.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 2, 2023
• Study Start: January 29, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)