Effect of Electrical Muscle Stimulation in Critically Ill Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Critical Illness

Intervention / Treatment
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* Other: Electrical muscle stimulation (EMS)
* Other: Sham EMS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMS intervention<br>The experimental group will received EMS at a therapeutic level. | Other: Electrical muscle stimulation (EMS)<br>* EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.<br>|
| Sham Comparator: Sham<br>The sham group will receive EMS at a sub-therapeutic level. | Other: Sham EMS<br>* Sham EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of EMS treatment | the number of EMS treatments that are successfully applied will be expressed as a frequency of the total number of treatments attempted | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle strength | muscle strength using manual muscle testing | baseline, 2 weeks and 4 weeks | 
| muscle thickness | thickness of the quadriceps muscle will be assessed using muscle ultrasound | baseline, 2 weeks, 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critical illness, myopathy, electrical muscle stimulation