Neuromuscular Electrical Stimulation in Mechanically Ventilated Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-18

Study Completion Date

2023-02-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Intensive care unit-acquired muscle weakness (ICUAMW) is a common problem following an ICU admission and is associated with prolonged hospitalization, delayed weaning and increased mortality. Up to 25% of patients requiring mechanical ventilation (MV) for greater than 7 days develop ICUAW, and this figure may rise to 50-100% in the septic population. Long-term follow-up studies of survivors of critical illness have demonstrated significantly impaired health-related quality of life and physical functioning up to 5 years after ICU discharge, with weakness being the most commonly reported physical limitation. Early rehabilitation has been shown to be safe and feasible; however, commencement is often delayed due to a patient's inability to cooperate. An intervention that begins early in ICU admission without the need for patient volition may be beneficial in attenuating muscle wasting. Therefore, this study aims to evaluate the effect of neuromuscular electrical stimulation and early physical activity on ICU acquired muscle weakness in mechanically ventilated patient

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

MUSCLE EFFECTS OF NEUROMUSCULAR ELECTROSTIMULATION IN MECHANICALLY VENTILATED PATIENTS IN AN ICU

NCT06409611

Intensive Care Unit Acquired Weakness

RECRUITING NA

Rehabilitation of Critically Ill Patients With SARS-CoV-2 Variants in ICU With Limited Resources

NCT05450120

COVID-19 Acute Respiratory Distress Syndrome

UNKNOWN NA

Use of Neuromuscular Electrostimulation (NMES) for Treatment or Prevention of ICU-Associated Weakness

NCT00709124

Intensive Care Unit Muscle Weakness

COMPLETED NA

Efficacy of Different Treatments for the Intensive Care Unit Acquired Weakness

NCT04613908

Muscle Weakness Rehabilitation

COMPLETED NA

Functional Inspiratory Versus Expiratory Muscle Electrical Stimulation on Weaning Outcomes in Mechanically Ventilated Patients

NCT07204821

Icu

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A randomized controlled study will be carried out to achieve the aim of the current study. For three months, from July 15, 2022 to September 15, 2022, newly admitted patients will be screened. Patients in this trial will be recruited prospectively within 24 hours of admission to the general ICU. Computer-generated randomization will be used to assign patients to one of four groups: neuromuscular electrical stimulation (NMES), exercise (EX); combined therapy (NMES + EX); or conventional care (control group). A minimum total sample size of 120 samples will be included. According to sample size calculations treatment groups (NMES, EX, NMES + EX or conventional care) would be represented by a minimum of 30 patients. A total sample size a 120 will be selected for the study. All patients in the four groups will receive ICU standard care which includes sedation and weaning protocols.

Conventional care (Control Group):

Patients in this group will receive usual physiotherapy consisting of in-bed EXs and ICU standard care.

Exercise group (EX Group):

This group will receive passive/active exercise range of motion (ROM) exercises . ROM exercises will include major muscle groups (i.e. biceps, triceps, and lower limbs) and will be applied the second day of 1CU admission for seven days.

Neuromuscular Electrical Muscle Stimulation (NEMS Group):

Patients in NEMS group will receive neuromuscular electrical stimulation from the second day of ICU admission for seven days.

Neuromuscular electrical stimulation will be implemented simultaneously on the rectus femoris, vastus lateralis, and vastus medialis muscles of both lower limbs, with two stimulators, in two 30-min sessions per day starting from the second day after admission for seven days.

Combined therapy (NMES + EX):

Patients in this group will be subjected to NMES pulse EX. The application of NMES occurring simultaneously to the upper and lower limbs exercises.

The ICU acquired muscle weakness assessment tool will be developed by the researchers to assess and record occurrence of ICUAMW.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuromuscular Electrical Stimulation ICU Acquired Muscle Weakness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Conventional care

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Exercise Group

Passive/active range of motion exercises group

Group Type EXPERIMENTAL

Exercise group

Intervention Type PROCEDURE

This group will receive passive/active range of motion (ROM) exercises. ROM exercises will include major muscle groups (i.e. biceps, triceps, and lower limbs) and will be applied from second day till seventh day of admission .

Neuromuscular Electrical Muscle Stimulation group

Group Type EXPERIMENTAL

Neuromuscular Electrical Muscle Stimulation group

Intervention Type PROCEDURE

* Patients in NEMS group will receive neuromuscular electrical stimulation from second day till seventh day of admission.
* Neuromuscular electrical stimulation will be implemented simultaneously on the rectus femoris, vastus lateralis, and vastus medialis muscles of both lower limbs, with two stimulators, in two 30-min sessions per day starting from the second day till seventh day of admission .

Combined therapy (Neuromuscular Electrical Muscle Stimulation pulse limb exercise)

Combined therapy (Neuromuscular Electrical Muscle Stimulation pulse limb exercise).

Group Type EXPERIMENTAL

Neuromuscular Electrical Muscle Stimulation and Exercise group

Intervention Type PROCEDURE

Patients in this group will be subjected to Neuromuscular Electrical Muscle Stimulation and Exercise.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise group

This group will receive passive/active range of motion (ROM) exercises. ROM exercises will include major muscle groups (i.e. biceps, triceps, and lower limbs) and will be applied from second day till seventh day of admission .

Intervention Type PROCEDURE

Neuromuscular Electrical Muscle Stimulation group

* Patients in NEMS group will receive neuromuscular electrical stimulation from second day till seventh day of admission.
* Neuromuscular electrical stimulation will be implemented simultaneously on the rectus femoris, vastus lateralis, and vastus medialis muscles of both lower limbs, with two stimulators, in two 30-min sessions per day starting from the second day till seventh day of admission .

Intervention Type PROCEDURE

Neuromuscular Electrical Muscle Stimulation and Exercise group

Patients in this group will be subjected to Neuromuscular Electrical Muscle Stimulation and Exercise.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

EX Group NEMS group NMES + EX group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* aged ≥18 years,
* mechanically ventilated for ≥48 h
* remain in the intensive care ≥4 days.

Exclusion Criteria

* Pre-existing neuromuscular disease
* brain death
* peripheral vascular diseases (arterial lower limb disease and deep venous thrombosis)
* hemiplegia/quadriplegia
* lower limb amputation
* spinal injuries
* receiving muscle relaxant; cognitive impairment; body mass index (BMI) \> 35 kg/m2; bone fractures
* skin lesions
* presence of cardiac pacemaker
* end-stage cancer

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No