Trial Outcomes & Findings for High Protein, Core Muscle Rehab, Muscular Electrostimulation in Prolonged Mechanical Ventilation (NCT NCT05932134)
NCT ID: NCT05932134
Last Updated: 2025-12-17
Results Overview
weaning success defined as weaning from ventilator for 5 consecutive days
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
3 months
Results posted on
2025-12-17
Participant Flow
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.
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.
Participant milestones
| Measure |
Usual Care
Usual care as RCC protocol in Chang Gung Memorial hospital
|
UC + High Protein Diet (HP)
The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.
|
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.
|
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 \[range 50-65 mA\].
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
30
|
30
|
30
|
|
Overall Study
COMPLETED
|
8
|
26
|
28
|
29
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
We had analyze the difference of age between groups.
Baseline characteristics by cohort
| Measure |
Usual Care
n=10 Participants
Usual care as RCC protocol in Chang Gung Memorial hospital
|
UC + High Protein Diet (HP)
n=30 Participants
The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.
|
UC + HP + Core Muscle Rehabilitation
n=30 Participants
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.
|
UC + HP + Core Muscle Rehabilitation + Neuromuscular Electric Stimulation (NMES)
n=30 Participants
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 \[range 50-65 mA\].
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
72.8 years
STANDARD_DEVIATION 10.9 • n=10 Participants • We had analyze the difference of age between groups.
|
69.3 years
STANDARD_DEVIATION 11.9 • n=30 Participants • We had analyze the difference of age between groups.
|
67.2 years
STANDARD_DEVIATION 12.1 • n=30 Participants • We had analyze the difference of age between groups.
|
71.5 years
STANDARD_DEVIATION 9.1 • n=30 Participants • We had analyze the difference of age between groups.
|
69.7 years
STANDARD_DEVIATION 11.1 • n=100 Participants • We had analyze the difference of age between groups.
|
|
Sex: Female, Male
Female
|
2 Participants
n=10 Participants • We had analyze the sex ratio between groups.
|
14 Participants
n=30 Participants • We had analyze the sex ratio between groups.
|
14 Participants
n=30 Participants • We had analyze the sex ratio between groups.
|
11 Participants
n=30 Participants • We had analyze the sex ratio between groups.
|
41 Participants
n=100 Participants • We had analyze the sex ratio between groups.
|
|
Sex: Female, Male
Male
|
8 Participants
n=10 Participants • We had analyze the sex ratio between groups.
|
16 Participants
n=30 Participants • We had analyze the sex ratio between groups.
|
16 Participants
n=30 Participants • We had analyze the sex ratio between groups.
|
19 Participants
n=30 Participants • We had analyze the sex ratio between groups.
|
59 Participants
n=100 Participants • We had analyze the sex ratio between groups.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
modified Nutrition Risk in Critically ill (NUTRIC) score
|
5.3 units on a scale
STANDARD_DEVIATION 1.3 • n=10 Participants • We analyze the mNUTRIC score (range 0-10) between groups.
|
5.1 units on a scale
STANDARD_DEVIATION 1.4 • n=30 Participants • We analyze the mNUTRIC score (range 0-10) between groups.
|
4.8 units on a scale
STANDARD_DEVIATION 1.8 • n=30 Participants • We analyze the mNUTRIC score (range 0-10) between groups.
|
5.4 units on a scale
STANDARD_DEVIATION 1.8 • n=30 Participants • We analyze the mNUTRIC score (range 0-10) between groups.
|
5.1 units on a scale
STANDARD_DEVIATION 1.6 • n=100 Participants • We analyze the mNUTRIC score (range 0-10) between groups.
|
PRIMARY outcome
Timeframe: 3 monthsweaning success defined as weaning from ventilator for 5 consecutive days
Outcome measures
| Measure |
Usual care
n=10 Participants
Usual care as RCC protocol in Chang Gung Memorial hospital
|
UC + high protein diet (HP)
n=30 Participants
The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.
|
UC + HP + core muscle rehabilitation
n=30 Participants
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.
|
UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)
n=30 Participants
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 \[range 50-65 mA\].
|
|---|---|---|---|---|
|
Weaning Rate
|
3 Participants
|
20 Participants
|
22 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 3 monthsthrough the end of admission, up to 3 months
Outcome measures
| Measure |
Usual care
n=10 Participants
Usual care as RCC protocol in Chang Gung Memorial hospital
|
UC + high protein diet (HP)
n=30 Participants
The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.
|
UC + HP + core muscle rehabilitation
n=30 Participants
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.
|
UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)
n=30 Participants
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 \[range 50-65 mA\].
|
|---|---|---|---|---|
|
In Hospital Mortality
|
3 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 3 monthstotal ventilator use days in this admission
Outcome measures
| Measure |
Usual care
n=10 Participants
Usual care as RCC protocol in Chang Gung Memorial hospital
|
UC + high protein diet (HP)
n=30 Participants
The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.
|
UC + HP + core muscle rehabilitation
n=30 Participants
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.
|
UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)
n=30 Participants
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 \[range 50-65 mA\].
|
|---|---|---|---|---|
|
Length of Mechanical Ventilator Usage
|
74.4 days
Standard Deviation 27.1
|
56.5 days
Standard Deviation 24.1
|
57.1 days
Standard Deviation 29.9
|
41.1 days
Standard Deviation 12.9
|
SECONDARY outcome
Timeframe: 6 monthstotal ICU stay in this admission
Outcome measures
| Measure |
Usual care
n=10 Participants
Usual care as RCC protocol in Chang Gung Memorial hospital
|
UC + high protein diet (HP)
n=30 Participants
The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.
|
UC + HP + core muscle rehabilitation
n=30 Participants
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.
|
UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)
n=30 Participants
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 \[range 50-65 mA\].
|
|---|---|---|---|---|
|
Length of ICU Stay
|
31.3 days
Standard Deviation 12.8
|
25.7 days
Standard Deviation 7.9
|
26.0 days
Standard Deviation 8.3
|
23.7 days
Standard Deviation 7.5
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
UC + High Protein Diet (HP)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
UC + HP + Core Muscle Rehabilitation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
UC + HP + Core Muscle Rehabilitation + Neuromuscular Electric Stimulation (NMES)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place