Measured by treadmill testing. Absolute walking distance in meters at baseline and 3 months

Control group includes both BMT and BMT + SET and the treatment group includes NMES + BMT and NMES + BMT + SET Included participants with both baseline and 3 month treadmill data.

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

Included participants with both baseline and 3 month treadmill data. Control group includes both BMT and BMT + SET and the treatment group includes NMES + BMT and NMES + BMT + SET

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

Scores on the Intermittent Claudication Questionnaire range from 0 to 100, with higher scores indicating worse health related to intermittent claudication.

Includes all participants that completed the ICQ questionnaire.

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

Scores on the EuroQol Group 5-Dimension 5-Level questionnaire (EQ-5D-5L) health scale (a visual-analogue scale) range from 0 to 100, with higher scores indicating better health.

Includes all participants that completed the EQ-5D-5L questionnaire.

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

Scores on the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component Summary and Mental Component Summary range from 1 to 100, with higher scores indicating better quality of life.

Includes all participants that completed the SF-36 questionnaire.

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.

Includes all participants that had a volume flow measurement at baseline and 3 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.

ANCOVA model for changes in Laser Doppler Flowmetry (blood flux - measured in one leg) between baseline and follow up periods (3, 6 and 12 months) for the ITT population.

Includes all participants that completed the LDF assessment. Blood flux is unitless. Difference between the two groups (control vs device).

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.

Linear mixed model for changes in the transformed log Left Ankle Brachial Pressure Index (ABPI) between baseline and follow up periods (3, 6 and 12 months) for the ITT population.

Calculation between groups - assesses the difference between the two treatment groups between baseline and 12 months.

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.

All randomised patients (except screen failures)

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

EA (part of BMT): compliant if completed 75% or more of recommended level of EA (75% of minutes performing exercises recommended by centre).

Data for this Outcome Measure was pre-specified to be collected and assessed as a single group irrespective of intervention Arm/Group.

To report ease of device use and suggest any developments.

Participants asked to rate ease of use of device. 5 point scale from 1 (very easy) to 5 (very difficult) Includes all participants that were in the control arm and completed the device experience questionnaire.

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

Score on the EQ-5D-5L health index range from 0 to 100, with higher scores indicating better health. The EQ-5D-5L health index was calculated with the value set for England.

Includes all participants that completed the EuroQoL 5D (EQ5D) Health Index.

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

Scores on the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) Physical Component Summary and Mental Component Summary range from 1 to 100, with higher scores indicating better quality of life.

Includes all participants that completed the SF-36 Mental Component Summary.

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.

Linear Regression Model for Duplex ultrasonography (TAMV - measured in one leg) at 3 months for the ITT population.

Difference (calculation) between the two groups (control and treatment) and not per arm.

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.

Linear mixed model1 for changes in the transformed log Right Ankle Brachial Pressure Index (ABPI) between baseline and follow up periods (3, 6 and 12 months) for the ITT population.

Calculation between groups - assesses the difference between the two treatment groups between baseline and 12 months.

Calculation between the two groups (control and treatment).

Comparison of compliance with SET classes.

Participant's who attended SET programme.

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.

NMES: compliant if completed 75% or more of recommended level of NMES usage.

To report ease of device use and suggest any developments.

Participants asked whether they thought the device reduced leg pain. 5-point scale from 1 (yes, a lot) to 5 (not at all).

Includes all participants that were in the treatment (device) arm and that completed the device experience questionnaire.

To report ease of device use and suggest any developments.

Participants asked whether they thought the device increased walking distance. Includes all participants that were in the treatment (device) arm and that completed the device experience questionnaire.

To report ease of device use and suggest any developments.

Participants asked whether they used the device as instructed. Includes all participants that were in the treatment (device) arm and that completed the device experience questionnaire.

To report ease of device use and suggest any developments.

Participants asked whether they could have used the device more. Includes all participants that were in the treatment (device) arm and that completed the device experience questionnaire.

To report ease of device use and suggest any developments.

Participants asked whether they used the device following the 3 month treatment period. 5-point scale from 1 (Yes, a lot) to 5 (not at all).

Includes all participants that were in the treatment (device) arm and that completed the device experience questionnaire.

Subgroup analysis 1: Right censored Tobit regression model for AWD at 3 months to assess the effects SET sites vs non-SET sites (NMES+SET+BMT & SET+BMT vs NMES+BMT & BMT).

Subgroup analysis 1: Treatment effect in SET sites vs non-SET sites (NMES+SET+BMT & SET+BMT vs NMES+BMT & BMT).

Right censored Tobit regression model for AWD at 3 months to assess the effects of SET vs non-SET (subgroup1) for the ITT population (N=160).

Subgroup1 (Non-SET) as reference category. Between group calculation (not per arm). Unit of measure is "Units" as a square root transformation was used to normalise the data and used for the Regression Tobit model, rather than meters.

Subgroup analysis 2: Right censored Tobit Regression model for AWD at 3 months to assess the effects of NMES in the SET sites (NMES+SET+BMT vs SET+BMT).

Subgroup analysis 2: Treatment effect of NMES in the SET sites (NMES+SET+BMT vs SET+BMT).

Right censored Tobit Regression model for AWD at 3 months to assess the effects of EA+SET+NMES vs EA+SET (subgroup2) for the ITT population (N=90) Subgroup2 (BMT + SET) as reference category. Between group calculation (not per arm). Unit of measure is "Units" as a square root transformation was used to normalise the data and used for the Regression Tobit model, rather than meters.

Subgroup analysis 3: Right censored Tobit regression model for the AWD at 3 months to assess the effects of NMES in the non-SET sites (NMES+BMT vs BMT).

Subgroup analysis 3: Treatment effect of NMES in the non-SET sites (NMES+BMT vs BMT).

Right censored Tobit regression model for the AWD at 3 months to assess the effects of EA vs EA+NMES (subgroup3) for the ITT population (N=70) Subgroup3 (BMT) as reference category. Between group calculation (not per arm). Unit of measure is "Units" as a square root transformation was used to normalise the data and used for the Regression Tobit model, rather than meters.

Subgroup analysis 4: Right censored Tobit regression model for AWD at 3 months to assess the effects of (NMES+BMT) has a similar effect as (SET+BMT).

Subgroup analysis 4: Investigate if the treatment effect of (NMES+BMT) has a similar effect as (SET+BMT).

Right censored Tobit regression model for AWD at 3 months to assess the effects of EA+SET vs EA+NMES (subgroup4) for the ITT population (N=88) Subgroup4 (BMT+SET) as reference category. Between group calculation (not per arm). Unit of measure is "Units" as a square root transformation was used to normalise the data and used for the Regression Tobit model, rather than meters.

Subgroup analysis 5: Determine if (NMES+SET+BMT) is more effective than (NMES+BMT).

Subgroup analysis 5: Determine if (NMES+SET+BMT) is more effective than (NMES+BMT).

Right censored Tobit regression model for AWD at 3 months to assess the effects of EA+NMES vs EA+SET+NMES (subgroup5) for the ITT population (N=80).

Subgroup5 (BMT+NMES) as reference category. Between group calculation (not per arm). Unit of measure is "Units" as a square root transformation was used to normalise the data and used for the Regression Tobit model, rather than meters.

Subgroup analysis 6: Determine if (BMT) is more effective than (NMES+SET+BMT).

Subgroup analysis 6: Determine if (BMT) is more effective than (NMES+SET+BMT). Right censored Tobit regression model for AWD at 3 months to assess the effects of EA vs EA+SET+NMES (subgroup 6) for the ITT population (N=72) Subgroup6 (BMT+SET+NMES) as reference category. Between group calculation (not per arm). Unit of measure is "Units" as a square root transformation was used to normalise the data and used for the Regression Tobit model, rather than meters.

Subgroup analysis 7: Determine if (BMT) is more effective than (BMT+SET). The sample size in this group is N=80 (n=31 in BMT and n=49 in BMT+SET).

Subgroup analysis 7: Determine if BMT is more effective than BMT+SET. The sample size in this group is N=80 (n=31 in BMT and n=49 in BMT+SET). BMT as reference category.

Right censored Tobit regression model for AWD at 3 months to assess the effects of BMT vs BMT+SET (subgroup 7) for the ITT population.

Between group calculation (not per arm). Unit of measure is "Units" as a square root transformation was used to normalise the data and used for the Regression Tobit model, rather than meters.

Right censored Tobit regression model for Absolute Walking Distance (AWD) at 3 months for patients who walked a short distance at baseline in the ITT population (N=40). The AWD at baseline was divided into three strati: Short, Medium and Long distances (set at <25%, 25%-75% and >75% respectively) using the descriptive statistics - short distance defined as <100m.

Right censored Tobit regression model for Absolute Walking Distance (AWD) at 3 months for patients who walked a short distance at baseline in the ITT population (N=40). Control: Local Available Exercise Therapy (BMT and BMT+SET) as reference category.

Calculated between the two groups (control vs treatment) so not per arm.

Right censored Tobit regression model for Absolute Walking Distance (AWD) at 3 months for patients who walked a medium distance at baseline in the ITT population (N=80). The AWD at baseline was divided into three strati: Short, Medium and Long distances (set at <25%, 25%-75% and >75% respectively) using the descriptive statistics - medium distance defined as between 100m and 340m.

Right censored Tobit regression model for Absolute Walking Distance (AWD) at 3 months for patients who walked a medium distance at baseline in the ITT population (N=80). Control: Local Available Exercise Therapy (BMT and BMT+SET) as reference category.

Calculated between the two groups (control vs treatment) so not per arm.

Right censored Tobit regression model for Absolute Walking Distance (AWD) at 3 months for patients who walked a long distance at baseline in the ITT population (N=40). The AWD at baseline was divided into three strati: Short, Medium and Long distances (set at <25%, 25%-75% and >75% respectively) using the descriptive statistics - long distance defined as >340m.

Right censored Tobit regression model for Absolute Walking Distance (AWD) at 3 months for patients who walked a long distance at baseline in the ITT population (N=40). Control: Local Available Exercise Therapy (BMT and BMT+SET) as reference category.

Calculated between the two groups (control vs treatment) so not per arm.