NCT05932134

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〕

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prolonged Mechanical Ventilation
• Protein Deficiency

Interventions

Type	Name	Description
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.
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
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 \[range 50-65 mA\].

Timeline

• Start date: 2023-09-18
• Primary completion: 2025-03-21
• Completion: 2025-03-21
• First posted: 2023-07-06
• Last updated: 2025-12-17
• Results posted: 2025-12-17

Locations

1 site across 1 country: Taiwan