Effect of Neuromuscular Calf Stimulation and Intermittent Pneumatic Compression on Lower Limb Venous Hemodynamics

Study Overview
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Brief Summary
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What is known? Disorders of peripheral circulation result in vascular morbidity and mortality Augmentation of peripheral circulation has been shown to be of benefit in both venous and arterial disease The benefit of intermittent pneumatic compression is clinically well evidenced. The use of intermittent pneumatic compression is limited by compliance issues related to sleeve application and external power source. What new information will this trial contribute? - This evaluates the haemodynamic effect of a new electrical device for augmentation of peripheral circulation

Detailed Description
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RATIONALE - Enhancement of peripheral circulation has been shown to be of benefit in many vascular disorders, and the clinical effectiveness of intermittent pneumatic compression (IPC) is well established in peripheral vascular disease. OBJECTIVE - This study aims to compare the haemodynamic efficacy of a novel neuromuscular electrical stimulation (NMES) device with IPC in healthy subjects. METHODS - 10 healthy volunteers will be randomised into two groups, in an interventional cross-over trial. Baseline measurements of haemodynamic velocity and flow will be taken, then subjects given bilateral therapy with each of the two devices in turn. Laser doppler fluximetry readings will be taken from the hand and foot. Baseline readings will be compared with readings taken after immediate cessation of therapy, and after 10 minutes. Tolerability will be measured using a verbal reported score.

Official Title
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Effect of Neuromuscular Calf Stimulation and Intermittent Pneumatic Compression on Lower Limb Venous Hemodynamics

Conditions
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Intermittent Pneumatic Compression

Intervention / Treatment
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* Device: Neuromuscular stimulation, followed by intermittent pneumatic compression
* Device: Intermittent pneumatic compression, followed by neuromuscular stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Age >18 yrs, Body Mass Index (BMI) 17-30Kg/m2 Exclusion Criteria History of heart disease or respiratory disorder, pregnancy, history of peripheral vascular disease or previous thromboembolic event, ABPI< 0.9, cardiac pacemaker, history of leg fractures and/or presence of metal implants in the leg, long distance travel within one week prior to study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Half of recruited subjects (n=5) | Device: Neuromuscular stimulation, followed by intermittent pneumatic compression<br> <br> * Other names: Device 1 followed by a break, followed by device 2;|
| Experimental: Group 2<br>Other half of recruited subjects (n=5) | Device: Intermittent pneumatic compression, followed by neuromuscular stimulation<br> <br> * Other names: Device 2, followed by a short break then device 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPC(on) Peak Velocity Change From Baseline | Ultrasound measurements of peak velocity. This is taken from the left leg superficial femoral vein and artery | One day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neuromuscular stimulation, intermittent pneumatic compression