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NCT Number: NCT05932134

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

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.

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Key information

Conditions

Prolonged Mechanical Ventilation Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Protein Deficiency

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Thoracic Medicine, Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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 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].

Primary outcomes

  1. Weaning Rate

    Time frame: 3 months

    weaning success defined as weaning from ventilator for 5 consecutive days

Secondary outcomes

  1. In Hospital Mortality

    Time frame: 3 months

    through the end of admission, up to 3 months

  2. Length of Mechanical Ventilator Usage

    Time frame: 3 months

    total ventilator use days in this admission

  3. Length of ICU Stay

    Time frame: 6 months

    total ICU stay in this admission

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study 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〕

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 6, 2023
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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