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

This study has been completed.
Information provided by (Responsible Party):
Imperial College London Identifier:
First received: August 8, 2013
Last updated: January 9, 2014
Last verified: November 2012

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

Condition Intervention
Healthy Subjects
Intermittent Pneumatic Compression Versus Neuromuscular Electrical Stimulation
Device: Neuromuscular stimulator followed by IPC
Device: IPC followed by neuromuscular stimulator

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Enrollment: 10
Study Start Date: December 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
Half of recruited subjects (n=5)
Device: Neuromuscular stimulator followed by IPC
Other Name: Device 1 followed by a break, followed by device 2
Experimental: Group 2
Other half of recruited subjects (n=5)
Device: IPC followed by neuromuscular stimulator
Other Name: IPC as device one, followed by a short break then to receive neuromuscular stimulator

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.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01939288

United Kingdom
Academic Vascular Surgery, Charing Cross Hospital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
  More Information

Additional Information:
Responsible Party: Imperial College London Identifier: NCT01939288     History of Changes
Other Study ID Numbers: JROHH0324
Study First Received: August 8, 2013
Last Updated: January 9, 2014 processed this record on May 22, 2017