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Effect of Electrical Muscle Stimulation in Critically Ill Patients

This study has been completed.
The Lung Association
Information provided by (Responsible Party):
Sunita Mathur, University Health Network, Toronto Identifier:
First received: July 6, 2012
Last updated: February 5, 2016
Last verified: May 2015
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 Intervention Phase
Critical Illness Other: Electrical muscle stimulation (EMS) Other: Sham EMS Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Sunita Mathur, University Health Network, Toronto:

Primary Outcome Measures:
  • 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:
  • muscle strength [ Time Frame: baseline, 2 weeks and 4 weeks ]
    muscle strength using manual muscle testing

  • muscle thickness [ Time Frame: baseline, 2 weeks, 4 weeks ]
    thickness of the quadriceps muscle will be assessed using muscle ultrasound

Enrollment: 30
Study Start Date: July 2012
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Sunita Mathur, Principal Investigator, University Health Network, Toronto Identifier: NCT01637467     History of Changes
Other Study ID Numbers: 11-0639A
Study First Received: July 6, 2012
Last Updated: February 5, 2016

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

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes processed this record on September 21, 2017