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

Not Applicable

Recruiting

• Conditions: Prolonged Mechanical Ventilation; Protein Deficiency
• Interventions: Dietary Supplement: UC + high protein diet (HP); Behavioral: UC + HP + core muscle rehabilitation; Device: UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)

• Registration Number: NCT05932134
• Lead Sponsor: Chang Gung Memorial Hospital

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.

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 Timeline

• Study First Submitted: 2023-04-26
• Study First Submitted QC: 2023-07-05
• Study First Posted: 2023-07-06
• Study Start: 2023-09-18
• Status Verified: 2024-08
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Primary Completion: 2025-03-21
• Study Completion: 2025-03-21

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UC + high protein diet (HP)	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	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.
UC + HP + core muscle rehabilitation + neuromuscular electric stimulation (NMES)	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 \[range 50-65 mA\].

Primary Outcome Measures

Name	Time	Method
Weaning rate	3 months	weaning success defined as weaning from ventilator for 5 consecutive days

Secondary Outcome Measures

Name	Time	Method
Length of ICU stay and total length of hospitalization	6 momnths	total ICU stay and hospitalization days
In hospital mortality	6 months	Mortality event in this admission
Length of mechanical ventilator usage	3 months	total ventilator use days in this admission

Trial Locations

Locations (1)

Department of Thoracic Medicine, Chang Gung Memorial Hospital; 🇨🇳 Taoyuan, Taiwan