Prolonged Mechanical VentilationNCT05932134

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

A study testing UC + high protein diet (HP), UC + HP + core muscle rehabilitation and UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES) in people with Prolonged Mechanical Ventilation and Protein Deficiency, run by Chang Gung Memorial Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 20 to 100 years
Conditions the study is for: Prolonged Mechanical Ventilation, Protein Deficiency
What is being tested?: UC + high protein diet (HP), UC + HP + core muscle rehabilitation and UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)
Type of treatment: Medical device, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteTaiwan
Study dates: 18 Sep 2023to 21 Mar 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age ≥ 20 year old
using mechanical ventilator for more than 21 days (including patients under tracheostomy or endotracheal tube)
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)
maximal inspiratory pressure (MIP) < 30mmHg
under enteral nutrition (EN) via NG tube.

Who cannot join

Acute infection and sepsis (fever up to 38.5 degree)
Severe neuromuscular disease, or uncontrolled epilepsy
Bony fracture or DVT history
Wound over the abdomen
Congestive heart failure with EF < 40% or using pacemaker
BMI>35 kg/M2, or severe edema

Show all 9Show fewer

Patients with hepatic failure, rapid progressed malignancy, or pregnancy were also excluded.
Under parenteral nutrition (PN)
Use pacemaker

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

Department of Thoracic Medicine, Chang Gung Memorial Hospital
Taoyuan, 333

Other trials in Taiwan

About this study

Official title: The Effects of High Protein Supplementation, Core Muscle Rehabilitation and Neuromuscular Electrostimulation (NMES) Programs on Clinical Outcomes in Patients With Prolonged Mechanical Ventilation (PMV〕

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.

Conditions: Prolonged Mechanical Ventilation, Protein Deficiency
Being tested: UC + high protein diet (HP), UC + HP + core muscle rehabilitation, UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)
Medical subject headings: Protein Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
UC + HP + core muscle rehabilitationBehavioural
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].

Study groups in NCT05932134
Study group	Role	What they receive
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. Receives: Dietary Supplement: UC + high protein diet (HP)
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. Receives: Behavioral: UC + HP + core muscle rehabilitation
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]. Receives: Device: UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)

What is being measured

The primary outcome is the main question the study is designed to answer.

Weaning Rate
weaning success defined as weaning from ventilator for 5 consecutive days
Measured: 3 months

Secondary outcomes (3)

In Hospital Mortality
through the end of admission, up to 3 months
Measured: 3 months
Length of Mechanical Ventilator Usage
total ventilator use days in this admission
Measured: 3 months
Length of ICU Stay
total ICU stay in this admission
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Sep 202321 Mar 2025

First posted6 Jul 2023
Study start18 Sep 2023
Primary completion21 Mar 2025
Study completion21 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Prolonged Mechanical VentilationStudies of the same condition, open and under way.
More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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.
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05932134
Sponsor's protocol ID: 202300154A3
Status last verified: Aug 2024
First submitted: 26 Apr 2023
Last updated: 17 Dec 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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
Lin CY, Chang PJ, Hsieh MJ, Lo YL, Lin SW, Lin SM, Hung CY, Lo CY, Lin TY, Huang AC, Chang KW, Wang TY, Huang SW, Chang JY, Chou YF, Huang CC, Lin HC. Effects of protein, muscle rehabilitation and trunk neuromuscular electrostimulation in patients with prolonged mechanical ventilation: a prospective, randomized controlled pilot study. Ann Med. 2026 Dec;58(1):2728179. doi: 10.1080/07853890.2026.2728179. Epub 2026 Sep 22.
PubMed 42773805

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Humidification Effects on Airway Complications and Clinical Outcomes in Trauma ICU Patients on Mechanical Ventilation
Respiratory Insufficiency, Wounds and Injuries
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Prognostic Estimates Among ICU Clinicians
Mechanical Ventilation
Not yet recruiting
Effectiveness of Transcutaneous NMES as an Adjunct for Swallowing Disorders in Tracheotomized Patients
Dysphagia, NeuroMuscular Electrical Stimulation
Not yet recruitingObservational study
Predictors of Prolonged Mechanical Ventilation in Preterm Infants
Premature Birth, Respiration Failure
Recruiting
Incremental Dead Space Versus Capping Trial Before Tracheostomy Decannulation
Tracheostomy, Prolonged Mechanical Ventilation

All Prolonged Mechanical Ventilation trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of High Protein Supplementation, Core Muscle Rehabilitation and Neuromuscular Electrostimulation (NMES) Programs on Clinical Outcomes in Patients With Prolonged Mechanical Ventilation (PMV〕
ClinicalTrials.gov ID: NCT05932134
Acronym / sponsor ID: 202300154A3
Conditions: Prolonged Mechanical Ventilation, Protein Deficiency
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Chang Gung Memorial HospitalUniversity, hospital or other
Study start: 18 Sep 2023 (actual)
Primary completion: 21 Mar 2025 (actual)
Study completion: 21 Mar 2025 (actual)
First posted: 6 Jul 2023 (actual)
Results: Posted 17 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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

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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: 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.

Arm	Type	Receives
Usual care	No intervention	–Usual care as RCC protocol in Chang Gung Memorial hospital
UC + high protein diet (HP)	Experimental	Dietary Supplement: 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	Experimental	Behavioral: UC + HP + core muscle rehabilitationProtein 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)	Experimental	Device: 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].

Who may qualify

Ages: 20 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

age ≥ 20 year old
using mechanical ventilator for more than 21 days (including patients under tracheostomy or endotracheal tube)
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)
maximal inspiratory pressure (MIP) < 30mmHg
under enteral nutrition (EN) via NG tube.

Key exclusion criteria (9 listed)

Acute infection and sepsis (fever up to 38.5 degree)
Severe neuromuscular disease, or uncontrolled epilepsy
Bony fracture or DVT history
Wound over the abdomen
Congestive heart failure with EF < 40% or using pacemaker

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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)
UC + HP + core muscle rehabilitationCore muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks	Behavioural	UC + HP + core muscle rehabilitation
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)

Primary outcome

Weaning Rate
Time frame: 3 months
weaning success defined as weaning from ventilator for 5 consecutive days

3 secondary outcomes

In Hospital Mortality
Time frame: 3 months
Length of Mechanical Ventilator Usage
Time frame: 3 months
Length of ICU Stay
Time frame: 6 months

Results and safety

Results posted to the registry on 17 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care	10	8
UC + High Protein Diet (HP)	30	26
UC + HP + Core Muscle Rehabilitation	30	28
UC + HP + Core Muscle Rehabilitation + Neuromuscular Electric Stimulation (NMES)	30	29

Primary outcome: Weaning Rate

Time frame: 3 months. Count of participants. Unit: Participants

Measure	Usual care n = 10	UC + high protein diet (HP) n = 30	UC + HP + core muscle rehabilitation n = 30	UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES) n = 30
Value	3	20	22	26

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: from enrollment through the end of the admission, up to 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care	0 of 10 (0%)	0 of 10 (0%)	3 of 10
UC + High Protein Diet (HP)	0 of 30 (0%)	0 of 30 (0%)	5 of 30
UC + HP + Core Muscle Rehabilitation	0 of 30 (0%)	0 of 30 (0%)	5 of 30
UC + HP + Core Muscle Rehabilitation + Neuromuscular Electric Stimulation (NMES)	0 of 30 (0%)	0 of 30 (0%)	4 of 30

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 36297079Huang 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.
Derived from this study: PubMed 42773805Lin CY, Chang PJ, Hsieh MJ, Lo YL, Lin SW, Lin SM, Hung CY, Lo CY, Lin TY, Huang AC, Chang KW, Wang TY, Huang SW, Chang JY, Chou YF, Huang CC, Lin HC. Effects of protein, muscle rehabilitation and trunk neuromuscular electrostimulation in patients with prolonged mechanical ventilation: a prospective, randomized controlled pilot study. Ann Med. 2026 Dec;58(1):2728179. doi: 10.1080/07853890.2026.2728179. Epub 2026 Sep 22.
Individual participant dataSharing planned: No

Related trials for Prolonged Mechanical Ventilation

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chun Yu Lin principal investigator

Chang Gung Memorial Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weaning Rate (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05932134, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.