- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01930643
Electric Muscle Stimulation for Patients With Chronic Respiratory Failure
Effect of Electric Muscle Stimulation on Patients With Chronic Respiratory Failure
Background: After mechanical ventilation, 5-20% of patients with acute respiratory failure would depend on ventilator support more than 14 days because of critical-illness weakness and their underlying diseases such as heart failure and chronic obstructive pulmonary disease.
Hypothesis: Electric muscle stimulation(EMS) will improve their muscle strength and shorten their ventilator days.
Design: Randomized controlled trial. Adult patients with mechanical ventilation more than 14 days are eligible. EMS would be applied in experimental group 32 minutes/day on their bilateral thigh.
Study Overview
Status
Intervention / Treatment
Detailed Description
Randomized controlled trial involves the adult patients with invasive mechanical ventilation more than 14 days. The participants were not eligible for active rehabilitation because of drowisness or weakness(Medical Research Council (MRC) Scale for Muscle Strength≦ Grade 3).
EMS would be applied in experimental group 32 minutes/day on their bilateral thigh(quadriceps muscle).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Taipei, Taiwan
- Mackay Memorial Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult patient required mechanical ventilation more than 14 days
- No ability for active endurance exercise because of poor consciousness or limb weakness.
Exclusion Criteria:
- Pregnant women
- Limb wound/infection interfered with electric pad application
- Recent acute myocardial infarction or life-threatening arrhythmia
- Uncontrolled epilepsy
- Dying patients without attempt of ventilator weaning
- Absence of respiratory drive
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Electric muscle stimulation(EMS)
EMS:use programmed middle frequency electric stimulation device(HELEX 573)for both quadriceps stimulation, 32 minutes per day, 5 time per week.
|
HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day.
|
No Intervention: Control
Patients with routine passive rehabilitation program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ventilator-free Days
Time Frame: 28 days
|
the cumulative ventilator-free days after intervention, in following 28 days.
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Grip Power
Time Frame: 7 days after intervention
|
Weekly improvement of both hand grip muscle power in kilogram(Kg)
|
7 days after intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kuang H Cheng, MD, Mackay Memorial Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13MMHIS070
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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