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Completed

NCT Number: NCT01637467

Effect of Electrical Muscle Stimulation in Critically Ill Patients

Electrical muscle stimulation (EMS) is the therapy used to passively activate muscles using electrodes on the surface of the skin. EMS may be helpful in preserving muscle function in people who are on bedrest due to critical illness in the intensive care unit. The purpose of this study is to determine the safety and feasibility of implementing EMS in critically ill patients who are on mechanical ventilation for greater than 7 days, and examine the effects of 4 weeks of EMS on leg muscle size, muscle strength and functional outcomes in these patients. The investigators hypothesize that EMS will be safe and feasible and that critically ill patients receiving EMS will show a smaller loss of muscle size and strength than those in the control group, who do not receive EMS.

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Key information

Conditions

Critical Illness Disease Attributes Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • admitted to the medical-surgical ICU or cardiovascular ICU
  • walking independently prior to admission
  • mechanically ventilated for more than 7 days (i.e. prolonged ventilation)
  • receiving enteral or parenteral nutrition.

Exclusion criteria

  • history of neurological or psychiatric disease
  • primary muscle disease (e.g. muscular dystrophy, polymyositis)
  • catastrophic neurological event
  • receiving palliative care
  • contraindications to EMS (e.g. cardiac pacemaker/defibrillator, pregnancy, infected or cancerous lesions in proximity of electrode sites)
  • inadequate access to electrode sites due to medical devices
  • lower extremity edema affecting the thighs or buttocks
  • BMI > 35 kg/m2
  • allergies to adhesives or latex

Treatment and study plan

Electrical muscle stimulation (EMS)

Other

EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.

Sham EMS

Other

Sham EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.

Primary outcomes

  1. feasibility of EMS treatment

    Time frame: 4 weeks

    the number of EMS treatments that are successfully applied will be expressed as a frequency of the total number of treatments attempted

Secondary outcomes

  1. muscle strength

    Time frame: baseline, 2 weeks and 4 weeks

    muscle strength using manual muscle testing

  2. muscle thickness

    Time frame: baseline, 2 weeks, 4 weeks

    thickness of the quadriceps muscle will be assessed using muscle ultrasound

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • The Lung Association

Registry information

Official study title

The Effects of Electrical Muscle Stimulation (EMS) on Muscle Atrophy and Functional Outcomes in Critically Ill Patients; a Pilot Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 11, 2012
Registry last updated
Feb 9, 2016

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.

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