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Electric Muscle Stimulation for Patients With Chronic Respiratory Failure

Primary Purpose

Chronic Respiratory Failure, Critical Illness Myopathy

Status
Terminated
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
EMS
Sponsored by
Mackay Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Respiratory Failure focused on measuring Electric muscle stimulation, mechanical ventilation, chronic respiratory failure

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mackay Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Electric muscle stimulation(EMS)

Control

Arm Description

EMS:use programmed middle frequency electric stimulation device(HELEX 573)for both quadriceps stimulation, 32 minutes per day, 5 time per week.

Patients with routine passive rehabilitation program.

Outcomes

Primary Outcome Measures

Ventilator-free Days
the cumulative ventilator-free days after intervention, in following 28 days.

Secondary Outcome Measures

Grip Power
Weekly improvement of both hand grip muscle power in kilogram(Kg)

Full Information

First Posted
August 25, 2013
Last Updated
April 18, 2019
Sponsor
Mackay Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01930643
Brief Title
Electric Muscle Stimulation for Patients With Chronic Respiratory Failure
Official Title
Effect of Electric Muscle Stimulation on Patients With Chronic Respiratory Failure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
slow recruitment and change of faculty
Study Start Date
August 21, 2013 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mackay Memorial Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Respiratory Failure, Critical Illness Myopathy
Keywords
Electric muscle stimulation, mechanical ventilation, chronic respiratory failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electric muscle stimulation(EMS)
Arm Type
Experimental
Arm Description
EMS:use programmed middle frequency electric stimulation device(HELEX 573)for both quadriceps stimulation, 32 minutes per day, 5 time per week.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients with routine passive rehabilitation program.
Intervention Type
Device
Intervention Name(s)
EMS
Intervention Description
HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day.
Primary Outcome Measure Information:
Title
Ventilator-free Days
Description
the cumulative ventilator-free days after intervention, in following 28 days.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Grip Power
Description
Weekly improvement of both hand grip muscle power in kilogram(Kg)
Time Frame
7 days after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuang H Cheng, MD
Organizational Affiliation
Mackay Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mackay Memorial Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Electric Muscle Stimulation for Patients With Chronic Respiratory Failure

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