Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Half of recruited subjects (n=5) |
|
| Group 2 | Experimental | Other half of recruited subjects (n=5) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuromuscular stimulation, followed by intermittent pneumatic compression | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| IPC(on) Peak Velocity Change From Baseline | Ultrasound measurements of peak velocity. This is taken from the left leg superficial femoral vein and artery | One day |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| NMES(on) Peak Velocity Change From Baseline | One day |
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kate Williams | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Vascular Surgery, Charing Cross Hospital | London | W6 8RF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24722790 | Result | 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. |
| Label | URL |
|---|---|
| PI information | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Half of recruited subjects (n=5) Neuromuscular stimulator followed by IPC |
| FG001 | Group 2 | Other half of recruited subjects (n=5) IPC followed by neuromuscular stimulator |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Intermittent pneumatic compression, followed by neuromuscular stimulation | Device |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
Healthy
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Half of recruited subjects (n=5) Neuromuscular stimulator followed by IPC |
| BG001 | Group 2 | Other half of recruited subjects (n=5) IPC followed by neuromuscular stimulator |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | IPC(on) Peak Velocity Change From Baseline | Ultrasound measurements of peak velocity. This is taken from the left leg superficial femoral vein and artery | Posted | Median | Inter-Quartile Range | cm/s | One day |
|
|
| ||||||||||||||||||||||||||
| Other Pre-specified | NMES(on) Peak Velocity Change From Baseline | Posted | Median | Inter-Quartile Range | cm/s | One day |
|
|
|
10 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | Neuromuscular stimulator | 0 | 10 | 0 | 10 | 0 | 10 |
| EG001 | Group 2 | Intermittent pneumatic compression | 0 | 10 | 0 | 10 | 0 | 10 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Miss Katherine Williams | Imperial College London | 020 3311 7335 | k.williams@imperial.ac.uk |
| Male |
|
|