Electric Muscle Stimulation for Patients With Chronic Respiratory Failure
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|ClinicalTrials.gov Identifier: NCT01930643|
Recruitment Status : Suspended (slow recruitment and change of faculty)
First Posted : August 29, 2013
Last Update Posted : November 8, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Respiratory Failure Critical Illness Myopathy||Device: EMS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Electric Muscle Stimulation on Patients With Chronic Respiratory Failure|
|Study Start Date :||August 2013|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2017|
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.
- ventilator-free days [ Time Frame: 28 days ]the number of days between successful weaning from mechanical ventilation and day 28 after study enrollment
- Grip power [ Time Frame: 7 days ]Weekly improvement of both hand grip muscle power in kilogram(Kg)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930643
|Mackay Memorial Hospital|
|Principal Investigator:||Kuang H Cheng, MD||Mackay Memorial Hospital|