Effect of Electrical Muscle Stimulation in Critically Ill Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2015-10-31

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.

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Detailed Description

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Conditions

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Critical Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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EMS intervention

The experimental group will received EMS at a therapeutic level.

Group Type EXPERIMENTAL

Electrical muscle stimulation (EMS)

Intervention Type OTHER

EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.

Sham

The sham group will receive EMS at a sub-therapeutic level.

Group Type SHAM_COMPARATOR

Sham EMS

Intervention Type OTHER

Sham EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.

Interventions

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Electrical muscle stimulation (EMS)

EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.

Intervention Type OTHER

Sham EMS

Sham EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No