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

August 8, 2013
January 9, 2014
December 2012
December 2013   (final data collection date for primary outcome measure)
Haemodynamic flow [ Time Frame: One day ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01939288 on ClinicalTrials.gov Archive Site
Laser doppler fluximetry [ Time Frame: One day ] [ Designated as safety issue: No ]
Laser doppler readings will be taken from the left foot and hand of subjects whilst undergoing the protocol
Same as current
Not Provided
Not Provided
 
Effect of Neuromuscular Calf Stimulation and Intermittent Pneumatic Compression on Lower Limb Venous Hemodynamics
Not Provided

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Healthy Subjects
  • Intermittent Pneumatic Compression Versus Neuromuscular Electrical Stimulation
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 2013
December 2013   (final data collection date for primary outcome measure)

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

Both
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01939288
JROHH0324
Yes
Imperial College London
Imperial College London
Not Provided
Not Provided
Imperial College London
November 2012

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