Effect of Electrical Muscle Stimulation in Critically Ill Patients

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637467
• Other study ID #: 11-0639A
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: July 6, 2012
• Last updated: February 5, 2016
• Start date: July 2012
• Est. completion date: October 2015

Study information

• Verified date: May 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• Electrical muscle stimulation (EMS)
EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.
• Sham EMS
Sham EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	The Lung Association

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	muscle strength	muscle strength using manual muscle testing	baseline, 2 weeks and 4 weeks	No
Secondary	muscle thickness	thickness of the quadriceps muscle will be assessed using muscle ultrasound	baseline, 2 weeks, 4 weeks	No