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Effect of Electrical Muscle Stimulation in Critically Ill Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
The Lung Association
Information provided by (Responsible Party):
Sunita Mathur, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01637467
First received: July 6, 2012
Last updated: July 9, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Critical Illness
Other: Electrical muscle stimulation (EMS)
Other: Sham EMS
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Electrical Muscle Stimulation (EMS) on Muscle Atrophy and Functional Outcomes in Critically Ill Patients; a Pilot Randomized Controlled Trial

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • feasibility of EMS treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    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:
  • muscle strength [ Time Frame: baseline, 2 weeks and 4 weeks ] [ Designated as safety issue: No ]
    muscle strength using manual muscle testing

  • muscle thickness [ Time Frame: baseline, 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
    thickness of the quadriceps muscle will be assessed using muscle ultrasound


Estimated Enrollment: 24
Study Start Date: July 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: EMS intervention
The experimental group will received EMS at a therapeutic level.
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 Comparator: Sham
The sham group will receive EMS at a sub-therapeutic level.
Other: Sham EMS
Sham EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01637467

Locations
Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
The Lung Association
Investigators
Principal Investigator: Vincent Lo, BSc(PT) University Health Network, Toronto
Principal Investigator: Sunita Mathur, PhD University of Toronto
  More Information

No publications provided

Responsible Party: Sunita Mathur, Principal Investigator, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01637467     History of Changes
Other Study ID Numbers: 11-0639A
Study First Received: July 6, 2012
Last Updated: July 9, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
critical illness
myopathy
electrical muscle stimulation

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014