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The goal of this clinical trial is to learn about in patients with prolong mechanical ventilation. This main questions aims to answer are:
Participants will receive high protein diet, core muscle rehabilitation, neuromuscular electric stimulation (NMES).
Researchers will compare patients with interventions to control group to see if high protein diet, core muscle rehabilitation, neuromuscular electric stimulation works.
The investigator aims to investigate the efficacy of below list methods in patients with prolong mechanical ventilator:
Participants will randomly stratify into four groups: (1) Usual care (UC), (2) UC + high protein diet (HP), (3) UC + HP + core muscle rehabilitation, (4) UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES).
Researchers will compare group 2,3,4 to control group (1, usual care) to see if high protein diet, core muscle rehabilitation, neuromuscular electric stimulation works.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care | No Intervention | Usual care as RCC protocol in Chang Gung Memorial hospital | |
| UC + high protein diet (HP) | Experimental | The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day. |
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| UC + HP + core muscle rehabilitation | Experimental | Protein provision was not reduced in case of renal failure. Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks. |
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| UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES) | Experimental | NMES was applied for 30 min, twice per day, 5 days per week, for 3 weeks via surface rectangular electrodes. Electrodes were placed on back designed to activate latissimus dorsi and abdominal wall designed to activate the transversus abdominis and internal and external oblique muscles. Electrical muscle stimulation was performed by using a commercial stimulator (GEMORE, GM300E, Taipei, Taiwan) with biphasic waves at a simulation frequency of 30 Hz and pulse width of 400s, cycling 2s on and 4s off. Electrical muscle stimulation intensity was gradually increased until a visible muscle contraction was observed (median 60 mA [range 50-65 mA]. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UC + high protein diet (HP) | Dietary Supplement | The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day. |
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| Measure | Description | Time Frame |
|---|---|---|
| Weaning Rate | weaning success defined as weaning from ventilator for 5 consecutive days | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| In Hospital Mortality | through the end of admission, up to 3 months | 3 months |
| Length of Mechanical Ventilator Usage | total ventilator use days in this admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chun Yu Lin | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Thoracic Medicine, Chang Gung Memorial Hospital | Taoyuan | 333 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36297079 | Result | Huang SW, Lin HC, Chou YF, Lin TY, Lo CY, Huang HY, Fang YF, Hsieh MH, Lin SM, Lo YL, Hsieh MJ, Kao KC, Lin CY, Huang CC. The Impact of Higher Protein Intake in Patients with Prolonged Mechanical Ventilation. Nutrients. 2022 Oct 20;14(20):4395. doi: 10.3390/nu14204395. |
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According to the order of enrollment, patients will be randomly assigned into four groups: (1) Usual care (UC) + high protein diet (HP), (2) UC + HP + core muscle rehabilitation, (3) UC + HP + core muscle rehabilitation + neuromuscular electrostimulation (NMES) (4) UC. Patients were randomized accordingly using a table of random numbers and sealed envelopes. After randomization, on the first three day, we initiated interventions and maintained intervention for 21 days.
The inclusion criteria were as follows: 1. age ≥ 20 year old, 2. latest 21 days after their admission into the ICU, using mechanical ventilator for more than 21 days , 3. stable clinical condition, 4. maximal inspiratory pressure (MIP) < 30mmHg, 5. under enteral nutrition (EN) via NG tube.
We obtained written informed consent from the patients or their legally acceptable surrogate.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Usual care as RCC protocol in Chang Gung Memorial hospital |
| FG001 | UC + High Protein Diet (HP) | The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 9, 2022 |
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Participants will randomly stratify into four groups: (1) Usual care (UC), (2) UC + high protein diet (HP), (3) UC + HP + core muscle rehabilitation, (4) UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES).
Researchers will compare group 2,3,4 to control group (1, usual care) to see if high protein diet, core muscle rehabilitation, neuromuscular electric stimulation works.
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| UC + HP + core muscle rehabilitation | Behavioral | Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks |
|
| UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES) | Device | NMES was applied for 30 min, twice per day, 5 days per week, for 3 weeks via surface rectangular electrodes. Electrodes were placed on back designed to activate latissimus dorsi and abdominal wall designed to activate the transversus abdominis and internal and external oblique muscles. Electrical muscle stimulation was performed by using a commercial stimulator (GEMORE, GM300E, Taipei, Taiwan) with biphasic waves at a simulation frequency of 30 Hz and pulse width of 400s, cycling 2s on and 4s off. Electrical muscle stimulation intensity was gradually increased until a visible muscle contraction was observed (median 60 mA [range 50-65 mA]. |
|
| 3 months |
| Length of ICU Stay | total ICU stay in this admission | 6 months |
| FG002 | UC + HP + Core Muscle Rehabilitation | Protein provision was not reduced in case of renal failure. Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks. |
| FG003 | UC + HP + Core Muscle Rehabilitation + Neuromuscular Electric Stimulation (NMES) | NMES was applied for 30 min, twice per day, 5 days per week, for 3 weeks via surface rectangular electrodes. Electrodes were placed on back designed to activate latissimus dorsi and abdominal wall designed to activate the transversus abdominis and internal and external oblique muscles. Electrical muscle stimulation was performed by using a commercial stimulator (GEMORE, GM300E, Taipei, Taiwan) with biphasic waves at a simulation frequency of 30 Hz and pulse width of 400s, cycling 2s on and 4s off. Electrical muscle stimulation intensity was gradually increased until a visible muscle contraction was observed (median 60 mA [range 50-65 mA]. |
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| NOT COMPLETED |
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A total 100 patients were enrolled.
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Usual care as RCC protocol in Chang Gung Memorial hospital |
| BG001 | UC + High Protein Diet (HP) | The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day. |
| BG002 | UC + HP + Core Muscle Rehabilitation | Protein provision was not reduced in case of renal failure. Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks. |
| BG003 | UC + HP + Core Muscle Rehabilitation + Neuromuscular Electric Stimulation (NMES) | NMES was applied for 30 min, twice per day, 5 days per week, for 3 weeks via surface rectangular electrodes. Electrodes were placed on back designed to activate latissimus dorsi and abdominal wall designed to activate the transversus abdominis and internal and external oblique muscles. Electrical muscle stimulation was performed by using a commercial stimulator (GEMORE, GM300E, Taipei, Taiwan) with biphasic waves at a simulation frequency of 30 Hz and pulse width of 400s, cycling 2s on and 4s off. Electrical muscle stimulation intensity was gradually increased until a visible muscle contraction was observed (median 60 mA [range 50-65 mA]. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | We had analyze the difference of age between groups. | Mean | Standard Deviation | years |
| |||||||||
| Sex: Female, Male | We had analyze the sex ratio between groups. | Count of Participants | Participants | No |
| |||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| modified Nutrition Risk in Critically ill (NUTRIC) score | a scoring system for nutrition status evaluation in critical illness patients. (including age, APACHE II, SOFA, comorbidities, Days from hospital to ICU admission) 5-0 =>High Score (Associated with worse clinical outcomes (mortality, ventilation), These patients are the most likely to benefit from aggressive nutrition therapy.) 0-4 =>LOW Score (These patients have a low malnutrition risk) | We analyze the mNUTRIC score (range 0-10) between groups. | Mean | Standard Deviation | units on a scale |
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| 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 | Weaning Rate | weaning success defined as weaning from ventilator for 5 consecutive days | Posted | Count of Participants | Participants | 3 months |
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| Secondary | In Hospital Mortality | through the end of admission, up to 3 months | Posted | Count of Participants | Participants | 3 months |
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| Secondary | Length of Mechanical Ventilator Usage | total ventilator use days in this admission | Posted | Mean | Standard Deviation | days | 3 months |
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| Secondary | Length of ICU Stay | total ICU stay in this admission | Posted | Mean | Standard Deviation | days | 6 months |
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from enrollment through the end of the admission, up to 3 months
adverse event defined as related to the intervention. If the mortality was not happened during intervention period or directly related to the intervention, it's not defined as adverse events of this study.
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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 | Usual Care | Usual care as RCC protocol in Chang Gung Memorial hospital | 3 | 10 | 0 | 10 | 0 | 10 |
| EG001 | UC + High Protein Diet (HP) | The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day. | 5 | 30 | 0 | 30 | 0 | 30 |
| EG002 | UC + HP + Core Muscle Rehabilitation | Protein provision was not reduced in case of renal failure. Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks. | 5 | 30 | 0 | 30 | 0 | 30 |
| EG003 | UC + HP + Core Muscle Rehabilitation + Neuromuscular Electric Stimulation (NMES) | NMES was applied for 30 min, twice per day, 5 days per week, for 3 weeks via surface rectangular electrodes. Electrodes were placed on back designed to activate latissimus dorsi and abdominal wall designed to activate the transversus abdominis and internal and external oblique muscles. Electrical muscle stimulation was performed by using a commercial stimulator (GEMORE, GM300E, Taipei, Taiwan) with biphasic waves at a simulation frequency of 30 Hz and pulse width of 400s, cycling 2s on and 4s off. Electrical muscle stimulation intensity was gradually increased until a visible muscle contraction was observed (median 60 mA [range 50-65 mA]. | 4 | 30 | 0 | 30 | 0 | 30 |
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First, our trial is a single-center trial made in RCC. The nutritional protocol, interventions were not blinded to the staff, which may possibly introduce bias. Moreover, we calculated caloric intake and protein intake using body weight as ESPEN guideline. We didn't use calorimetry to predict precisely energy consumption. The nutrition need might be not adequate for patients. This study enrolled relatively small number of subjects in each group, which may limit the validity.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M.D | Linkou Chang Gung Memorial Hospital | +886-3-3281200 | 8467 | pitiful1984@gmail.com |
| Dec 10, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D011488 | Protein Deficiency |
| ID | Term |
|---|---|
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000073600 | Diet, High-Protein |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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