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Effect of Electrical Muscle Stimulation in Critically Ill Patients

University Health Network, Toronto logo

University Health Network, Toronto

Status and phase

Completed
Phase 2
Phase 1

Conditions

Critical Illness

Treatments

Other: Electrical muscle stimulation (EMS)
Other: Sham EMS

Study type

Interventional

Funder types

Other

Identifiers

NCT01637467
11-0639A

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

30 participants in 2 patient groups

EMS intervention
Experimental group
Description:
The experimental group will received EMS at a therapeutic level.
Treatment:
Other: Electrical muscle stimulation (EMS)
Sham
Sham Comparator group
Description:
The sham group will receive EMS at a sub-therapeutic level.
Treatment:
Other: Sham EMS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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