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

NCT ID: NCT05932134

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-18
• Study Completion Date: 2025-03-21

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.

Conditions

Prolonged Mechanical Ventilation; Protein Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Usual care

Usual care as RCC protocol in Chang Gung Memorial hospital

Group Type: NO_INTERVENTION

No interventions assigned to this group

UC + high protein diet (HP)

The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.

Group Type: EXPERIMENTAL

UC + high protein diet (HP)

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

UC + HP + core muscle rehabilitation

Intervention Type: 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)

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 \[range 50-65 mA\].

Group Type: EXPERIMENTAL

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

Intervention Type: 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 \[range 50-65 mA\].

Interventions

UC + high protein diet (HP)

The HP groups will maintain unchanged total daily caloric intake and increasing protein content to 1.5g/kg/day.

Intervention Type: DIETARY_SUPPLEMENT

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

Intervention Type: BEHAVIORAL

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 \[range 50-65 mA\].

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chun Yu Lin

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Department of Thoracic Medicine, Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

References

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.

Reference Type: RESULT

PMID: 36297079 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

202300154A3

Identifier Type: -

Identifier Source: org_study_id