Does Neuromuscular Electrical Stimulation Improve the Absolute Walking Distance in Patients With Intermittent Claudication Compared to Best Available Treatment?

Difference in the Initial Claudication Distance (ICD) at 3 Months Between the Two Treatment Groups

Measured by treadmill testing. ICD in meters at baseline and 3 months

Time frame: 3 months

Quality of Life - Intermittent Claudication Questionnaire (ICQ)

Patient questionnaire. Used to assess change in disease-specific QoL.

Time frame: Baseline, 3 months, 6 months, 12 months

Quality of Life - EuroQoL 5D (EQ5D) Health Scale

Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.

Time frame: Baseline, 3 month, 6 month and 12 months

Quality of Life Short Form 36 (SF-36) Physical Component Summary

Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.

Time frame: Baseline, 3 month, 6 month and 12 months

Haemodynamic Assessment - Duplex Ultrasonography - Difference in Volume Flow Between Baseline and 3 Months

Using an arterial ultrasound probe and pre-set volume flow algorithms on a duplex ultrasound machine, flow within the common femoral artery (CFA), of the most affected limb, will be measured, approximately 5cm below the mid-inguinal point at the groin. Measures include volume flow (VF, cc/min) to assess whether using the device increases this measurement.

Time frame: 3 months

Haemodynamic Assessment - Laser Doppler Flowmetry (LDF) - Difference in Blood Flux Between Baseline and 12 Months

The single fibre laser optical probe of the LDF machine will be positioned on the dorsal aspect of the foot using single use adhesive pads. Flux, as a measure of superficial skin blood flow will be measured to assess whether using the device increases this measurement.

Time frame: Baseline, 3 month, 6 month and 12 months

Haemodynamic Assessment - Difference in Ankle Brachial Pressure Index (ABPI) - Left - Between Baseline and 12 Months

The brachial blood pressure from the right arm using a manual blood pressure monitor cuff and Doppler will be recorded after 5 minutes of resting supine on a couch. The systolic blood pressure of the anterior tibial artery and posterior tibial artery at the ankle will also be recorded using the cuff and Dopplermethod. The ratio of the systolic brachial and ankle pressures will form the ABPI measurement.

Time frame: Baseline, 3 month, 6 month and 12 months

Health Economic Assessment

The economic analyses will compare local therapy (supervised exercise therapy (SET) or exercise advice (EA) only) versus the intervention (local therapy + Neuromuscular Electrical Stimulation, NMES) in patients with Intermittent Claudication. The analyses will be based on a (i) patient level in-trial cost-effectiveness analysis, (ii) a decision model and (iii) budget impact assessment. The in-trial analysis will calculate quality-adjusted life years (QALYs) over the one year time horizon of the trial.

Time frame: Baseline, 3 month, 6 month and 12 months

Compliance With Interventions - Exercise Advice (EA)

Comparison of compliance with exercise advice as per local standard of care.

Time frame: 3 months

Device Experience Questionnaire - Ease of Use

To report ease of device use and suggest any developments.

Time frame: 3 months

Quality of Life - EuroQoL 5D (EQ5D) Health Index

Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.

Time frame: Baseline, 3 months, 6 months, 12 months

Quality of Life Short Form 36 (SF-36) Mental Component Summary

Patient questionnaire. Used to assess the generic QoL and will allow economic assessment based on intervention and score improvement.

Time frame: Baseline, 3 months, 6 months, 12 months

Haemodynamic Assessment - Duplex Ultrasonography - Difference in Time Average Mean Velocity Between Baseline and 3 Months

Using an arterial ultrasound probe and pre-set volume flow algorithms on a duplex ultrasound machine, flow within the common femoral artery (CFA), of the most affected limb, will be measured, approximately 5cm below the mid-inguinal point at the groin. Measures include time-averaged mean volume (TAMV, cm/s) to assess whether using the device increases this measurement.

Time frame: 3 months

Haemodynamic Assessment - Difference in Ankle Brachial Pressure Index (ABPI) - Right - Between Baseline and 12 Months

The brachial blood pressure from the right arm using a manual blood pressure monitor cuff and Doppler will be recorded after 5 minutes of resting supine on a couch. The systolic blood pressure of the anterior tibial artery and posterior tibial artery at the ankle will also be recorded using the cuff and Dopplermethod. The ratio of the systolic brachial and ankle pressures will form the ABPI measurement.

Time frame: Baseline, 3 months, 6 months and 12 months

Compliance With Interventions - Supervised Exercise Therapy (SET)

Comparison of compliance with SET classes.

Time frame: 3 months

Compliance With Interventions - Neuromuscular Electrical Stimulation (NMES)

Compliance with NMES device. NMES compliance data collected from the data logger fitted to device and patient diary will be combined to report overall compliance.

Time frame: 3 months

Device Experience Questionnaire - Reduces Leg Pain

To report ease of device use and suggest any developments.

Time frame: 3 months

Device Experience Questionnaire - Increased Walk Distance

To report ease of device use and suggest any developments.

Time frame: 3 months

Device Experience Questionnaire - Used as Instructed

To report ease of device use and suggest any developments.

Time frame: 3 months

Device Experience Questionnaire - Could Have Used More

To report ease of device use and suggest any developments.

Time frame: 3 months

Device Experience Questionnaire - Used After Treatment

To report ease of device use and suggest any developments.

Time frame: 3 months