Clinical trial NCT01894997: A Comparison of the Effects of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression on Blood Flow in the Lower Limb
Official title: A Comparison of the Effects of Neuromuscular Electrical Stimulation and Intermittent Pneumatic Compression on Lower Limb Haemodynamics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Thrombosis
Keywords: Deep Vein Thrombosis
Neuromuscular Electrical Stimulation
Intermittent Pneumatic Compression
Doppler Ultrasound
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
Collaborators: name: Irish Research Council
name: Galway Clinic
First posted: 2013-07-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among hospitalized patients, with death occurring in approximately 6% of cases. It involves the formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood), hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to blood vessel wall), collectively known as Virchow's triad.

Intermittent pneumatic compression (IPC) and neuromuscular electrical stimulation (NMES) have been shown to improve lower limb blood flow. However, few studies have directly compared the two methods and those that have, have used dated NMES techniques.

The objective of this study is to compare the two methods in terms of blood flow, in both a young and an older population.

Detailed description: Deep Vein Thrombosis (DVT) is a life threatening condition and a serious concern among hospitalized patients, with death occurring in approximately 6% of cases. It involves the formation of a clot where stagnant blood flow occurs, predominantly in the deep veins of the legs. Three mechanisms underlie DVT, venous stasis (slowing or stopping of the blood), hypercoagulability (increased clotting) and damage to blood vessel endothelium (damage to blood vessel wall), collectively known as Virchow's triad.

Intermittent Pneumatic Compression (IPC) involves the use of an inflatable cuff placed around the limb. This cuff inflates and deflates intermittently in order to squeeze blood from the underlying veins. Neuromuscular Electrical Stimulation (NMES) leads to a contraction of muscles by delivering a series of controlled electrical pulses via skin surface electrodes placed over the motor points of the targeted muscle.

Eligibility criteria: Inclusion Criteria:

* Free from any known illness
* Between 18 and 40 years of age
* Between 55 and 65 years of age

Exclusion Criteria:

* History of heart/respiratory problems
* Pregnancy
* Presence of implants, including cardiac pacemakers and orthopaedic implants
* History of neurological disorder
* History of severe arterial disease or known dermatological problems

Primary outcomes:
measure: Blood flow measurements from the lower limb
timeFrame: Two hours (plus or minus half an hour)
Secondary outcomes:
measure: Blood pressure
timeFrame: Two hours (plus or minus half an hour)
measure: Heart rate
timeFrame: Two hours (plus or minus half an hour)
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: National University of Ireland, Galway
Study officials:
affiliation: National University of Ireland, Galway
name: Gearoid OLaighin, PhD
role: PRINCIPAL_INVESTIGATOR
References: