Haemodynamic PhysiologyMuscle PumpNCT02532556
Electrical Stimulation of the Muscle Pumps of the Leg
A study testing Electrical stimulation (Digitimer) in people with Haemodynamic Physiology, run by Imperial College London.
Trial summary
The most efficient way of electrically stimulating the calf muscles has not been identified. The investigators aim to investigate this using a matrix of electrical parameters, and measuring the outcome with vascular ultrasound of the leg. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Haemodynamic Physiology
- What is being tested?
- Electrical stimulation (Digitimer)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- May 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Current good health
Who cannot join
- History of cardiovascular disease
- Ankle Brachial Pressure Index <0.9
- Venous reflux>0.5s
- Pregnancy
About this study
The most efficient way of electrically stimulating the calf muscles has not been identified. The investigators aim to investigate this using a matrix of electrical parameters, and measuring the outcome with vascular ultrasound of the leg.
Read the detailed description
Blood is aided on its journey to the heart by the action of the muscles of the legs. Muscle contraction squeezes the deep veins of the leg and pushes blood upwards, back towards the heart. In immobilised patients, or those with blood vessel problems, the pumping process can be helped by machines that either squeeze or shock the muscles of the calf (e.g. intermittent pneumatic compression, electrical stimulating devices). Many are licensed for medical use, and some are common place in hospitals and outpatient departments.
- Conditions
- Haemodynamic Physiology
- Being tested
- Electrical stimulation (Digitimer)
- Keywords
- Haemodynamic physiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical stimulation (Digitimer)Device
Stimulation with Digitimer (DS7A HV, Digitimer Ltd, UK) over motor point of muscle in protocol. 1Hz, pulse duration 1ms, maximum compliance voltage 200V. Current set to twice motor threshold
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Stimulation of muscle in this order: vastus medials, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, lateral head gastrocnemius Receives: Device: Electrical stimulation (Digitimer) |
| 2 | Experimental | Stimulation of muscle in this order: rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, lateral head gastrocnemius, vastus medials Receives: Device: Electrical stimulation (Digitimer) |
| 3 | Experimental | Stimulation of muscle in this order: vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris Receives: Device: Electrical stimulation (Digitimer) |
| 4 | Experimental | Stimulation of muscle in this order: tibialis anterior, peroneus longus, and the medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis Receives: Device: Electrical stimulation (Digitimer) |
| 5 | Experimental | Stimulation of muscle in this order: peroneus longus, medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis, tibialis anterior Receives: Device: Electrical stimulation (Digitimer) |
| 6 | Experimental | Stimulation of muscle in this order: medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus Receives: Device: Electrical stimulation (Digitimer) |
| 7 | Experimental | Stimulation of muscle in this order: lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, Receives: Device: Electrical stimulation (Digitimer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous Haemodynamic Measurements (Volume Flow Rate)
Measurement by ultrasound, in right femoral vein. Flow rate (ml/min).
Measured: Baseline compared to that after 10-mins stimulation (2-mins to take measurements)
Venous Haemodynamic Measurements (Time Averaged Maximum Velocity)
Measurement by ultrasound, in right femoral vein. Time averaged maximum velocity (cm/s).
Measured: Baseline compared to that after 10-mins stimulation (2-mins to take measurements)
Secondary outcomes (1)
Pain Grading on Stimulation
Visual analogue scale (0-minimum pain, to 100-maximum pain)
Measured: During stimulation (10-mins each muscle)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Haemodynamic PhysiologyStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alun Davies, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532556
- Sponsor's protocol ID
- 15IC2528
- Acronym
- Muscle Pump
- Status last verified
- Nov 2020
- First submitted
- 10 Aug 2015
- Last updated
- 27 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Evans DR, Williams KJ, Strutton PH, Davies AH. The comparative hemodynamic efficacy of lower limb muscles using transcutaneous electrical stimulation. J Vasc Surg Venous Lymphat Disord. 2016 Apr;4(2):206-14. doi: 10.1016/j.jvsv.2015.10.009. Epub 2016 Jan 12.
PubMed 26993869
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation of the Muscle Pumps of the Leg
- ClinicalTrials.gov ID
- NCT02532556
- Acronym / sponsor ID
- Muscle Pump / 15IC2528
- Conditions
- Haemodynamic Physiology
- Keywords
- Haemodynamic physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Aug 2015 (estimated)
- Results
- Posted 27 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The most efficient way of electrically stimulating the calf muscles has not been identified. The investigators aim to investigate this using a matrix of electrical parameters, and measuring the outcome with vascular ultrasound of the leg.
Detailed description
Blood is aided on its journey to the heart by the action of the muscles of the legs. Muscle contraction squeezes the deep veins of the leg and pushes blood upwards, back towards the heart. In immobilised patients, or those with blood vessel problems, the pumping process can be helped by machines that either squeeze or shock the muscles of the calf (e.g. intermittent pneumatic compression, electrical stimulating devices). Many are licensed for medical use, and some are common place in hospitals and outpatient departments.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Electrical stimulation (Digitimer)Stimulation of muscle in this order: vastus medials, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, lateral head gastrocnemius |
| 2 | Experimental | Device: Electrical stimulation (Digitimer)Stimulation of muscle in this order: rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, lateral head gastrocnemius, vastus medials |
| 3 | Experimental | Device: Electrical stimulation (Digitimer)Stimulation of muscle in this order: vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris |
| 4 | Experimental | Device: Electrical stimulation (Digitimer)Stimulation of muscle in this order: tibialis anterior, peroneus longus, and the medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis |
| 5 | Experimental | Device: Electrical stimulation (Digitimer)Stimulation of muscle in this order: peroneus longus, medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis, tibialis anterior |
| 6 | Experimental | Device: Electrical stimulation (Digitimer)Stimulation of muscle in this order: medial head gastrocnemius, lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus |
| 7 | Experimental | Device: Electrical stimulation (Digitimer)Stimulation of muscle in this order: lateral head gastrocnemius, vastus medials, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, medial head gastrocnemius, |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years or older
- Current good health
Key exclusion criteria (4 listed)
- History of cardiovascular disease
- Ankle Brachial Pressure Index <0.9
- Venous reflux>0.5s
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrical stimulation (Digitimer)Stimulation with Digitimer (DS7A HV, Digitimer Ltd, UK) over motor point of muscle in protocol. 1Hz, pulse duration 1ms, maximum compliance voltage 200V. Current set to twice motor threshold | Device | 1, 2, 3, 4, 5, 6, 7 |
Primary outcome
Venous Haemodynamic Measurements (Volume Flow Rate)
Time frame: Baseline compared to that after 10-mins stimulation (2-mins to take measurements)
Measurement by ultrasound, in right femoral vein. Flow rate (ml/min).
Venous Haemodynamic Measurements (Time Averaged Maximum Velocity)
Time frame: Baseline compared to that after 10-mins stimulation (2-mins to take measurements)
Measurement by ultrasound, in right femoral vein. Time averaged maximum velocity (cm/s).
1 secondary outcome
Pain Grading on Stimulation
Time frame: During stimulation (10-mins each muscle)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26993869Evans DR, Williams KJ, Strutton PH, Davies AH. The comparative hemodynamic efficacy of lower limb muscles using transcutaneous electrical stimulation. J Vasc Surg Venous Lymphat Disord. 2016 Apr;4(2):206-14. doi: 10.1016/j.jvsv.2015.10.009. Epub 2016 Jan 12.
- Individual participant dataSharing planned: No
Related trials for Haemodynamic Physiology
Recruiting
Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds
Angina (Stable), Coronary Artery Disease(CAD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alun Davies principal investigator
Imperial College London
Questions about this trial
What is this clinical trial studying?
A study testing Electrical stimulation (Digitimer) in people with Haemodynamic Physiology, run by Imperial College London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous Haemodynamic Measurements (Volume Flow Rate) (time frame: Baseline compared to that after 10-mins stimulation (2-mins to take measurements)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02532556, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2020.