Effect of Neuromuscular Calf Stimulation and Intermittent Pneumatic Compression on Lower Limb Venous Hemodynamics
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01939288 |
Recruitment Status
:
Completed
First Posted
: September 11, 2013
Last Update Posted
: January 10, 2014
|
Tracking Information | |||
---|---|---|---|
First Submitted Date ICMJE | August 8, 2013 | ||
First Posted Date ICMJE | September 11, 2013 | ||
Last Update Posted Date | January 10, 2014 | ||
Study Start Date ICMJE | December 2012 | ||
Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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
|
||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | Complete list of historical versions of study NCT01939288 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures ICMJE |
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
|
||
Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Outcome Measures ICMJE | Not Provided | ||
Original Other Outcome Measures ICMJE | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Effect of Neuromuscular Calf Stimulation and Intermittent Pneumatic Compression on Lower Limb Venous Hemodynamics | ||
Official Title ICMJE | Not Provided | ||
Brief Summary | What is known?
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. |
||
Study Type ICMJE | Interventional | ||
Study Phase | Not Applicable | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
||
Condition ICMJE |
|
||
Intervention ICMJE |
|
||
Study Arms |
|
||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||
Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
10 | ||
Original Estimated Enrollment ICMJE | Same as current | ||
Actual Study Completion Date | December 2013 | ||
Actual Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | 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 |
||
Sex/Gender |
|
||
Ages | Child, Adult, Senior | ||
Accepts Healthy Volunteers | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United Kingdom | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01939288 | ||
Other Study ID Numbers ICMJE | JROHH0324 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Imperial College London | ||
Study Sponsor ICMJE | Imperial College London | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Imperial College London | ||
Verification Date | November 2012 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |