Study Stopped
slow recruitment and change of faculty
Electric Muscle Stimulation for Patients With Chronic Respiratory Failure
Effect of Electric Muscle Stimulation on Patients With Chronic Respiratory Failure
1 other identifier
interventional
13
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 21, 2013
CompletedFirst Submitted
Initial submission to the registry
August 25, 2013
CompletedFirst Posted
Study publicly available on registry
August 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
July 8, 2019
CompletedJuly 8, 2019
April 1, 2019
1.8 years
August 25, 2013
April 18, 2019
April 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ventilator-free Days
the cumulative ventilator-free days after intervention, in following 28 days.
28 days
Secondary Outcomes (1)
Grip Power
7 days after intervention
Study Arms (2)
Electric muscle stimulation(EMS)
EXPERIMENTALEMS:use programmed middle frequency electric stimulation device(HELEX 573)for both quadriceps stimulation, 32 minutes per day, 5 time per week.
Control
NO INTERVENTIONPatients with routine passive rehabilitation program.
Interventions
HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day.
Eligibility Criteria
You may qualify if:
- Adult patient required mechanical ventilation more than 14 days
- No ability for active endurance exercise because of poor consciousness or limb weakness.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mackay Memorial Hospital
Taipei, Taiwan
Results Point of Contact
- Title
- Dr. Kuang-Hua Cheng
- Organization
- Mackay Memorial Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Kuang H Cheng, MD
Mackay Memorial Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Visiting staff
Study Record Dates
First Submitted
August 25, 2013
First Posted
August 29, 2013
Study Start
August 21, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
July 8, 2019
Results First Posted
July 8, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share