Clinical trial NCT01939288: Effect of Neuromuscular Calf Stimulation and Intermittent Pneumatic Compression on Lower Limb Venous Hemodynamics
Official title: Effect of Neuromuscular Calf Stimulation and Intermittent Pneumatic Compression on Lower Limb Venous Hemodynamics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intermittent Pneumatic Compression
Keywords: neuromuscular stimulation
intermittent pneumatic compression
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: IPC(on) Peak Velocity Change From Baseline
timeFrame: One day
Secondary outcomes:
Other outcomes:
measure: NMES(on) Peak Velocity Change From Baseline
timeFrame: One day
Locations:
city: London
country: United Kingdom
facility: Academic Vascular Surgery, Charing Cross Hospital
Study officials:
affiliation: Imperial College London
name: Kate Williams
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williams KJ, Moore HM, Davies AH. Haemodynamic changes with the use of neuromuscular electrical stimulation compared to intermittent pneumatic compression. Phlebology. 2015 Jun;30(5):365-72. doi: 10.1177/0268355514531255. Epub 2014 Apr 10.