Effect of Electrical Muscle Stimulation in Critically Ill Patients

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. Identifier: NCT01637467
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : February 9, 2016
The Lung Association
Information provided by (Responsible Party):
Sunita Mathur, University Health Network, Toronto

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Critical Illness Other: Electrical muscle stimulation (EMS) Other: Sham EMS Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Electrical Muscle Stimulation (EMS) on Muscle Atrophy and Functional Outcomes in Critically Ill Patients; a Pilot Randomized Controlled Trial
Study Start Date : July 2012
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: EMS intervention
The experimental group will received EMS at a therapeutic level.
Other: Electrical muscle stimulation (EMS)
EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.

Sham Comparator: Sham
The sham group will receive EMS at a sub-therapeutic level.
Other: Sham EMS
Sham EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.

Primary Outcome Measures :
  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 Outcome Measures :
  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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01637467

Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
The Lung Association
Principal Investigator: Vincent Lo, BSc(PT) University Health Network, Toronto
Principal Investigator: Sunita Mathur, PhD University of Toronto

Responsible Party: Sunita Mathur, Principal Investigator, University Health Network, Toronto Identifier: NCT01637467     History of Changes
Other Study ID Numbers: 11-0639A
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: May 2015

Keywords provided by Sunita Mathur, University Health Network, Toronto:
critical illness
electrical muscle stimulation

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes