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Effect of Electrical Muscle Stimulation in Critically Ill Patients

Primary Purpose

Critical Illness

Status

Completed

Phase

Phase 1

Locations

Canada

Study Type

Interventional

Intervention

Electrical muscle stimulation (EMS)

Sham EMS

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring critical illness, myopathy, electrical muscle stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Toronto General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

EMS intervention

Sham

Arm Description

The experimental group will received EMS at a therapeutic level.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

muscle strength

muscle strength using manual muscle testing

muscle thickness

thickness of the quadriceps muscle will be assessed using muscle ultrasound

Full Information

NCT ID

NCT01637467

First Posted

July 6, 2012

Last Updated

February 5, 2016

Sponsor

University Health Network, Toronto

Collaborators

The Lung Association

1. Study Identification

Unique Protocol Identification Number

NCT01637467

Brief Title

Effect of Electrical Muscle Stimulation in Critically Ill Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Health Network, Toronto

Collaborators

The Lung Association

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Illness

Keywords

critical illness, myopathy, electrical muscle stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

EMS intervention

Arm Type

Experimental

Arm Description

The experimental group will received EMS at a therapeutic level.

Arm Title

Sham

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Electrical muscle stimulation (EMS)

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Sham EMS

Intervention Description

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

Primary Outcome Measure Information:

Title

feasibility of EMS treatment

Description

the number of EMS treatments that are successfully applied will be expressed as a frequency of the total number of treatments attempted

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

muscle strength

Description

muscle strength using manual muscle testing

Time Frame

baseline, 2 weeks and 4 weeks

Title

muscle thickness

Description

thickness of the quadriceps muscle will be assessed using muscle ultrasound

Time Frame

baseline, 2 weeks, 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vincent Lo, BSc(PT)

Organizational Affiliation

University Health Network, Toronto

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sunita Mathur, PhD

Organizational Affiliation

University of Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

Toronto General Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

12. IPD Sharing Statement

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Effect of Electrical Muscle Stimulation in Critically Ill Patients

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