Effect of Electrical Muscle Stimulation in Critically Ill Patients

NCT01637467 | Completed Phase 1

• 1 other identifier: 11-0639A
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

critical illness; myopathy; electrical muscle stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• muscle strength

  baseline, 2 weeks and 4 weeks

• muscle thickness

  baseline, 2 weeks, 4 weeks

Study Arms (2)

EMS intervention

EXPERIMENTAL

The experimental group will received EMS at a therapeutic level.

Other: Electrical muscle stimulation (EMS)

Sham

SHAM COMPARATOR

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

Other: Sham EMS

Interventions

Electrical muscle stimulation (EMS) OTHER

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

EMS intervention

Sham EMS OTHER

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

Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• The Lung Association: collaborator

Study Sites (1)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Critical Illness; Muscular Diseases

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Vincent Lo, BSc(PT)

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

• Sunita Mathur, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 11, 2012
• Study Start: July 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 9, 2016

Record last verified: 2015-05

Locations

CA (1)