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OpenTrials
Completed

NCT Number: NCT02532556

Electrical Stimulation of the Muscle Pumps of the Leg

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.

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Key information

Conditions

Haemodynamic Physiology

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • Current good health

Exclusion criteria

  • History of cardiovascular disease
  • Ankle Brachial Pressure Index <0.9
  • Venous reflux>0.5s
  • Pregnancy

Treatment and study plan

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

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. Pain Grading on Stimulation

    Time frame: During stimulation (10-mins each muscle)

    Visual analogue scale (0-minimum pain, to 100-maximum pain)

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Acronym: Muscle Pump

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 25, 2015
Registry last updated
Nov 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.