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

Not Applicable

Completed

• Conditions: Intermittent Pneumatic Compression
• Interventions: Device: Intermittent pneumatic compression, followed by neuromuscular stimulation; Device: Neuromuscular stimulation, followed by intermittent pneumatic compression

• Registration Number: NCT01939288
• Lead Sponsor: Imperial College London

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-08-08
• Study First Submitted QC: 2013-09-05
• Study First Posted: 2013-09-11
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Results First Submitted: 2014-05-09
• Results First Submitted QC: 2019-05-08
• Results First Posted: 2019-07-22
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-19
• Last Update Posted: 2019-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	Intermittent pneumatic compression, followed by neuromuscular stimulation	Other half of recruited subjects (n=5)
Group 1	Neuromuscular stimulation, followed by intermittent pneumatic compression	Half of recruited subjects (n=5)

Primary Outcome Measures

Name	Time	Method
IPC(on) Peak Velocity Change From Baseline	One day	Ultrasound measurements of peak velocity. This is taken from the left leg superficial femoral vein and artery

Trial Locations

Locations (1)

Academic Vascular Surgery, Charing Cross Hospital; 🇬🇧 London, United Kingdom