Effect of Electrical Muscle Stimulation in Critically Ill Patients
This study is currently recruiting participants.
Verified July 2012 by University Health Network, Toronto
Sponsor:
University Health Network, Toronto
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 14, 2012
Last verified: July 2012
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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: | December 2013 |
| Estimated Primary Completion Date: | July 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01637467
Contacts
| Contact: Vincent Lo, BSc(PT) | vincent.lo@uhn.ca | |
| Contact: Sunita Mathur, PhD | 416-978-7761 | sunita.mathur@utoronto.ca |
Locations
| Canada, Ontario | |
| Toronto General Hospital | Recruiting |
| Toronto, Ontario, Canada, M5G 2C4 | |
| Contact: Vincent Lo, BSc(PT) vincent.lo@uhn.ca | |
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 14, 2012 |
| 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 May 22, 2013