Effect of Electrical Muscle Stimulation in Critically Ill Patients

Phase 1

Completed

• Conditions: Critical Illness
• Interventions: Other: Sham EMS; Other: Electrical muscle stimulation (EMS)

• Registration Number: NCT01637467
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-11
• Status Verified: 2015-05
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Last Update Submitted: 2016-02-05
• Last Update Posted: 2016-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	Sham EMS	The sham group will receive EMS at a sub-therapeutic level.
EMS intervention	Electrical muscle stimulation (EMS)	The experimental group will received EMS at a therapeutic level.

Primary Outcome Measures

Name	Time	Method
feasibility of EMS treatment	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

Name	Time	Method
muscle thickness	baseline, 2 weeks, 4 weeks	thickness of the quadriceps muscle will be assessed using muscle ultrasound
muscle strength	baseline, 2 weeks and 4 weeks	muscle strength using manual muscle testing

Trial Locations

Locations (1)

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada