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

Tracking Information
First Submitted Date ICMJE	August 8, 2013
First Posted Date ICMJE	September 11, 2013
Last Update Posted Date	January 10, 2014
Study Start Date ICMJE	December 2012
Actual Primary Completion Date	December 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: September 5, 2013)	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; (submitted: September 5, 2013)	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 Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (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
Actual Enrollment ICMJE; (submitted: September 5, 2013)	10
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	December 2013
Actual 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
IPD Sharing Statement	Not Provided
Responsible Party	Imperial College London
Study Sponsor ICMJE	Imperial College London
Collaborators ICMJE	Not Provided
Investigators ICMJE	Not Provided
PRS Account	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