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slow recruitment and change of faculty
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electric muscle stimulation(EMS) | Experimental | EMS:use programmed middle frequency electric stimulation device(HELEX 573)for both quadriceps stimulation, 32 minutes per day, 5 time per week. |
|
| Control | No Intervention | Patients with routine passive rehabilitation program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMS | Device | HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day. |
| Measure | Description | Time Frame |
|---|---|---|
| Ventilator-free Days | the cumulative ventilator-free days after intervention, in following 28 days. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Grip Power | Weekly improvement of both hand grip muscle power in kilogram(Kg) | 7 days after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kuang H Cheng, MD | Mackay Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mackay Memorial Hospital | Taipei | Taiwan |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. EMS: HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day. |
| FG001 | Control | Patients with routine passive rehabilitation program. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. EMS: HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Ventilator-free Days | the cumulative ventilator-free days after intervention, in following 28 days. | Posted | Median | Inter-Quartile Range | day | 28 days |
|
The first 14 days after Electric Muscle Stimulation is applied
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. EMS: HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kuang-Hua Cheng | Mackay Memorial Hospital | +886-975837711 | jeff01@mmh.org.tw |
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| BG001 |
| Control |
Patients with routine passive rehabilitation program. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Grip Power | Weekly improvement of both hand grip muscle power in kilogram(Kg) | Not Posted | 7 days after intervention | Participants |
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Control | Patients with routine passive rehabilitation program. | 0 | 6 | 0 | 6 | 0 | 6 |
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