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

NCT05932134 | Completed Results

• 1 other identifier: 202300154A3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prolonged Mechanical Ventilation; Protein Deficiency

Outcome Measures

Primary Outcomes (1)

• Weaning Rate

  weaning success defined as weaning from ventilator for 5 consecutive days

  3 months

Secondary Outcomes (3)

• In Hospital Mortality

  3 months

• Length of Mechanical Ventilator Usage

  3 months

• Length of ICU Stay

  6 months

Study Arms (4)

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.

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.

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 \[range 50-65 mA\].

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

Interventions

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 + high protein diet (HP)

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

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 \[range 50-65 mA\].

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

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Thoracic Medicine, Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 36297079 RESULT

MeSH Terms

Conditions

Protein Deficiency

Interventions

Diet, High-Protein

Condition Hierarchy (Ancestors)

Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

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.

Results Point of Contact

• Title: M.D
• Organization: Linkou Chang Gung Memorial Hospital

pitiful1984@gmail.com

+886-3-3281200

Study Officials

• Chun Yu Lin

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: July 6, 2023
• Study Start: September 18, 2023
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: December 17, 2025
• Results First Posted: December 17, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)