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

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.

Study Overview

• Status: Completed
• Conditions: Prolonged Mechanical Ventilation; Protein Deficiency
• Intervention / Treatment: Dietary supplement: UC + high protein diet (HP); Behavioral: UC + HP + core muscle rehabilitation; Device: UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan District, Taiwan, 333
    • Department of Thoracic Medicine, Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.
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; Core muscle rehabilitation is sitting on bedside with or without aids, for 30 minutes, twice per day, 5 days per week, for 3 weeks
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); 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].

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weaning Rate	weaning success defined as weaning from ventilator for 5 consecutive days	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
In Hospital Mortality	through the end of admission, up to 3 months	3 months
Length of Mechanical Ventilator Usage	total ventilator use days in this admission	3 months
Length of ICU Stay	total ICU stay in this admission	6 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Principal Investigator: Chun Yu Lin, Chang Gung Memorial Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2023
• Primary Completion (Actual): March 21, 2025
• Study Completion (Actual): March 21, 2025

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 6, 2023

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Deficiency Diseases; Malnutrition; Nutritional and Metabolic Diseases; Protein Deficiency; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet Therapy; Nutrition Therapy; Diet; Diet, High-Protein
• Other Study ID Numbers: 202300154A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No