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CompletedNCT05932134Updated Dec 17, 2025Results posted

High Protein, Core Muscle Rehab, Muscular Electrostimulation in Prolonged Mechanical Ventilation

An interventional study of UC + high protein diet (HP) and UC + HP + core muscle rehabilitation in Prolonged Mechanical Ventilation and Protein Deficiency, sponsored by Chang Gung Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-12-17.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
20 Years to 100 Years
Sex
All
01

Study summary

The goal of this clinical trial is to learn about in patients with prolong mechanical ventilation. This main questions aims to answer are:

  • High protein formula intake benefit in successful weaning from ventilator
  • Core muscle rehabilitation benefit in successful weaning from ventilator
  • neuromuscular electric stimulation benefit in successful weaning from ventilator

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.

Read the detailed description

The investigator aims to investigate the efficacy of below list methods in patients with prolong mechanical ventilator:

  • High protein formula intake benefit in successful weaning from ventilator
  • Core muscle rehabilitation benefit in successful weaning from ventilator
  • neuromuscular electric stimulation benefit in successful weaning from 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.

02

Conditions studied

  • Prolonged Mechanical Ventilation
  • Protein Deficiency

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03

In context

Protein Deficiency

26 studies on the registry are indexed under Protein Deficiency; 4 are open to participants now.

This study's enrollment of 100 is above the median of 40 across 20 interventional studies indexed under Protein Deficiency.

Browse Protein Deficiency studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. age ≥ 20 year old
  2. using mechanical ventilator for more than 21 days (including patients under tracheostomy or endotracheal tube)
  3. stable clinical condition, without using inotropic agent (arterial blood gas pH : 7.35-7.45, PaO2≥60 mm Hg at FiO2 40%, absence of signs and symptoms of uncontrolled infection, and hemodynamic stability)
  4. maximal inspiratory pressure (MIP) \< 30mmHg
  5. under enteral nutrition (EN) via NG tube.

Exclusion criteria

Exclusion Criteria:

  1. Acute infection and sepsis (fever up to 38.5 degree)
  2. Severe neuromuscular disease, or uncontrolled epilepsy
  3. Bony fracture or DVT history
  4. Wound over the abdomen
  5. Congestive heart failure with EF \< 40% or using pacemaker
  6. BMI>35 kg/M2, or severe edema
  7. Patients with hepatic failure, rapid progressed malignancy, or pregnancy were also excluded.
  8. Under parenteral nutrition (PN)
  9. Use pacemaker
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • No intervention
    Usual care

    Usual care as RCC protocol in Chang Gung Memorial hospital

  • Experimental
    UC + high protein diet (HP)

    The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.

    Dietary Supplement: UC + high protein diet (HP)

  • Experimental
    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.

    Behavioral: UC + HP + core muscle rehabilitation

  • Experimental
    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 \[range 50-65 mA\].

    Device: UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)

Interventions

  • Dietary supplementUC + high protein diet (HP)

    The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.

  • BehavioralUC + HP + core muscle rehabilitation

    Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks

  • DeviceUC + 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 \[range 50-65 mA\].

06

What researchers measure

Primary outcomes

  1. Weaning Rate

    weaning success defined as weaning from ventilator for 5 consecutive days

    Time frame: 3 months

Secondary outcomes

  1. In Hospital Mortality

    through the end of admission, up to 3 months

    Time frame: 3 months

  2. Length of Mechanical Ventilator Usage

    total ventilator use days in this admission

    Time frame: 3 months

  3. Length of ICU Stay

    total ICU stay in this admission

    Time frame: 6 months

07

Results

Posted Dec 17, 2025
Limitations and caveats
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.

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.

Participant flow — Overall Study
MilestoneUsual CareUC + High Protein Diet (HP)UC + HP + Core Muscle RehabilitationUC + HP + Core Muscle Rehabilitation + Neuromuscular Electric Stimulation (NMES)
Started10303030
Completed8262829
Not completed2421

Outcome measures

PrimaryWeaning Rate

weaning success defined as weaning from ventilator for 5 consecutive days

Time frame:
3 months
Reported as:
Count of participants · Participants
Weaning Rate
ParticipantsUsual careUC + high protein diet (HP)UC + HP + core muscle rehabilitationUC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)
Weaning Rate3202226
SecondaryIn Hospital Mortality

through the end of admission, up to 3 months

Time frame:
3 months
Reported as:
Count of participants · Participants
In Hospital Mortality
ParticipantsUsual careUC + high protein diet (HP)UC + HP + core muscle rehabilitationUC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)
In Hospital Mortality3554
SecondaryLength of Mechanical Ventilator Usage

total ventilator use days in this admission

Time frame:
3 months
Reported as:
Mean · days
Length of Mechanical Ventilator Usage
daysUsual careUC + high protein diet (HP)UC + HP + core muscle rehabilitationUC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)
Length of Mechanical Ventilator Usage74.4 ± 27.156.5 ± 24.157.1 ± 29.941.1 ± 12.9
SecondaryLength of ICU Stay

total ICU stay in this admission

Time frame:
6 months
Reported as:
Mean · days
Length of ICU Stay
daysUsual careUC + high protein diet (HP)UC + HP + core muscle rehabilitationUC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)
Length of ICU Stay31.3 ± 12.825.7 ± 7.926.0 ± 8.323.7 ± 7.5

Adverse events

Collected over from enrollment through the end of the admission, up to 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Usual Care3/10 (30%)0/10 (0%)0/10 (0%)
UC + High Protein Diet (HP)5/30 (16.7%)0/30 (0%)0/30 (0%)
UC + HP + Core Muscle Rehabilitation5/30 (16.7%)0/30 (0%)0/30 (0%)
UC + HP + Core Muscle Rehabilitation + Neuromuscular Electric Stimulation (NMES)4/30 (13.3%)0/30 (0%)0/30 (0%)

Baseline characteristics

A total 100 patients were enrolled.

Age, Continuous
Age, Continuous(years)Usual CareUC + High Protein Diet (HP)UC + HP + Core Muscle RehabilitationUC + HP + Core Muscle Rehabilitation + Neuromuscular Electric Stimulation (NMES)Total
Mean72.8 ± 10.969.3 ± 11.967.2 ± 12.171.5 ± 9.169.7 ± 11.1
Sex: Female, Male
Sex: Female, Male(Participants)Usual CareUC + High Protein Diet (HP)UC + HP + Core Muscle RehabilitationUC + HP + Core Muscle Rehabilitation + Neuromuscular Electric Stimulation (NMES)Total
Female214141141
Male816161959
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Usual CareUC + High Protein Diet (HP)UC + HP + Core Muscle RehabilitationUC + HP + Core Muscle Rehabilitation + Neuromuscular Electric Stimulation (NMES)Total
Count of participants————0
modified Nutrition Risk in Critically ill (NUTRIC) score
modified Nutrition Risk in Critically ill (NUTRIC) score(units on a scale)Usual CareUC + High Protein Diet (HP)UC + HP + Core Muscle RehabilitationUC + HP + Core Muscle Rehabilitation + Neuromuscular Electric Stimulation (NMES)Total
Mean5.3 ± 1.35.1 ± 1.44.8 ± 1.85.4 ± 1.85.1 ± 1.6
08

Study locations

1 site
  • Department of Thoracic Medicine, Chang Gung Memorial Hospital
    Taoyuan, 333, Taiwan
09

References and documents

Publications

  • 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. PubMed 36297079 ↗

Study documents

  • Protocol and statistical analysis plan · Dec 9, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05932134
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Jul 6, 2023
Start date
Sep 18, 2023
Primary completion
Mar 21, 2025
Completion
Mar 21, 2025
Results posted
Dec 17, 2025
Last update
Dec 17, 2025

Study contacts

Chun Yu Lin
principal investigator · Chang Gung Memorial Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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