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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Imperial College London

ClinicalTrials.gov Identifier:

NCT01939288

First received: August 8, 2013

Last updated: January 9, 2014

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 8, 2013

Last Updated Date

January 9, 2014

Start Date ^ICMJE

December 2012

Primary Completion Date

December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Haemodynamic flow [ Time Frame: One day ]

Composite ultrasound measurements of venous and arterial peak velocity, time averaged maximum velocity, and flow rate. This is taken from the left leg superficial femoral vein and artery

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01939288 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Laser doppler fluximetry [ Time Frame: One day ]

Laser doppler readings will be taken from the left foot and hand of subjects whilst undergoing the protocol

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Not Provided

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

Healthy Subjects
Intermittent Pneumatic Compression Versus Neuromuscular Electrical Stimulation

Intervention ^ICMJE

Device: Neuromuscular stimulator followed by IPC
Other Name: Device 1 followed by a break, followed by device 2
Device: IPC followed by neuromuscular stimulator
Other Name: IPC as device one, followed by a short break then to receive neuromuscular stimulator

Study Arms

Experimental: Group 1
Half of recruited subjects (n=5)

Intervention: Device: Neuromuscular stimulator followed by IPC
Experimental: Group 2
Other half of recruited subjects (n=5)

Intervention: Device: IPC followed by neuromuscular stimulator

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2013

Primary Completion Date

December 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

Child, Adult, Senior

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United Kingdom

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01939288

Other Study ID Numbers ^ICMJE

JROHH0324

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Imperial College London

Study Sponsor ^ICMJE

Imperial College London

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Imperial College London

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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