Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Sub-group Analysis 1 - Difference in Absolute Walking Difference Between Baseline and 3 Months SET Sites vs Non-SET Sites |
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). |
3 months |
|
| Other |
Sub-group Analysis 2 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+SET+BMT vs SET+BMT) |
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). |
3 months |
|
| Other |
Sub-group Analysis 3 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+BMT vs BMT) |
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). |
3 months |
|
| Other |
Sub-group Analysis 4 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+BMT vs. SET+BMT) |
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). |
3 months |
|
| Other |
Sub-group Analysis 5 - Difference in Absolute Walking Difference Between Baseline and 3 Months (NMES+SET+BMT vs. NMES+BMT) |
Subgroup analysis 5: Determine if (NMES+SET+BMT) is more effective than (NMES+BMT). |
3 months |
|
| Primary |
Difference in the Absolute Walking Distance (AWD) at 3 Months Between the Two Treatment Groups |
Measured by treadmill testing. Absolute walking distance in meters at baseline and 3 months |
3 months |
|
| Secondary |
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 |
3 months |
|
| Secondary |
Quality of Life - Intermittent Claudication Questionnaire (ICQ) |
Patient questionnaire. Used to assess change in disease-specific QoL. |
Baseline, 3 months, 6 months, 12 months |
|
| Secondary |
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. |
Baseline, 3 month, 6 month and 12 months |
|
| Secondary |
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. |
Baseline, 3 month, 6 month and 12 months |
|
| Secondary |
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. |
3 months |
|
| Secondary |
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. |
Baseline, 3 month, 6 month and 12 months |
|
| Secondary |
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. |
Baseline, 3 month, 6 month and 12 months |
|
| Secondary |
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. |
Baseline, 3 month, 6 month and 12 months |
|
| Secondary |
Compliance With Interventions - Exercise Advice (EA) |
Comparison of compliance with exercise advice as per local standard of care. |
3 months |
|
| Secondary |
Device Experience Questionnaire - Ease of Use |
To report ease of device use and suggest any developments. |
3 months |
|
| Secondary |
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. |
Baseline, 3 months, 6 months, 12 months |
|
| Secondary |
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. |
Baseline, 3 months, 6 months, 12 months |
|
| Secondary |
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. |
3 months |
|
| Secondary |
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. |
Baseline, 3 months, 6 months and 12 months |
|
| Secondary |
Compliance With Interventions - Supervised Exercise Therapy (SET) |
Comparison of compliance with SET classes. |
3 months |
|
| Secondary |
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. |
3 months |
|
| Secondary |
Device Experience Questionnaire - Reduces Leg Pain |
To report ease of device use and suggest any developments. |
3 months |
|
| Secondary |
Device Experience Questionnaire - Increased Walk Distance |
To report ease of device use and suggest any developments. |
3 months |
|
| Secondary |
Device Experience Questionnaire - Used as Instructed |
To report ease of device use and suggest any developments. |
3 months |
|
| Secondary |
Device Experience Questionnaire - Could Have Used More |
To report ease of device use and suggest any developments. |
3 months |
|
| Secondary |
Device Experience Questionnaire - Used After Treatment |
To report ease of device use and suggest any developments. |
3 months |
|
