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

September 19, 2019 updated by: Imperial College London

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W6 8RF
        • Academic Vascular Surgery, Charing Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Half of recruited subjects (n=5)
Device: Neuromuscular stimulation, followed by intermittent pneumatic compression
Other Names:
  • Device 1 followed by a break, followed by device 2
Experimental: Group 2
Other half of recruited subjects (n=5)
Device: Intermittent pneumatic compression, followed by neuromuscular stimulation
Other Names:
  • Device 2, followed by a short break then device 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IPC(on) Peak Velocity Change From Baseline
Time Frame: One day
Ultrasound measurements of peak velocity. This is taken from the left leg superficial femoral vein and artery
One day

Other Outcome Measures

Outcome Measure
Time Frame
NMES(on) Peak Velocity Change From Baseline
Time Frame: One day
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

September 5, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Actual)

September 20, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JROHH0324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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