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Clinical Trials/NCT01637467
NCT01637467
Completed
Phase 1

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

University Health Network, Toronto1 site in 1 country30 target enrollmentJuly 2012

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Critical Illness
Sponsor
University Health Network, Toronto
Enrollment
30
Locations
1
Primary Endpoint
feasibility of EMS treatment
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2012
End Date
October 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sunita Mathur

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • muscle thickness(baseline, 2 weeks, 4 weeks)
  • muscle strength(baseline, 2 weeks and 4 weeks)

Study Sites (1)

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