Whole-Body Vibration Versus Neuro Muscular Electrical Stimulation on Patients With ICU Acquired Weakness

Cairo University (CU)

Status: Invitation-only

Conditions: Intensive Care (ICU); Muscle Weakness | Patient; Intensive Care (ICU) Myopathy

Treatments: Device: whole body VIBRATION Viberation; Device: Neuro muscular electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07336810

P.T.REC/012/005115 (Other Identifier)

Details and patient eligibility

About

Purpose: to investigate the effect of Whole-body vibration versus neuro-muscular electrical stimulation on patients with intensive care-acquired weakness. Methods: Sixty patients with Intensive Care Unit-acquired weakness (ICU AW) from both genders will be recruited and randomly assigned into two groups, Group A and Group B. Group A will include 30 patients who will practice Whole body vibration for two weeks twice daily in addition to their plan of treatment. Group B will include 30 patients who will receive neuromuscular electrical stimulation for two weeks, twice daily, in addition to their plan of treatment. All patients will be evaluated pre- and post-treatment for the MRC score, creatine phosphokinase, and total muscle strength and skeletal muscle thickness

Full description

A) Procedure for evaluation:

The practical section of the study will be undertaken in 2 weeks (two sessions per day). Measurements will be taken before the start of the training program then after the end of the 2-week training program in the following manner:

1. Manual muscle test (MMT) and medical research council score (MRC): will be used to assess muscle strength.
2. Laboratory investigations for CPK: Blood serum samples will be collected. For each sample, 5 mL of blood will be drawn for laboratory analyses to detect damage in skeletal muscle.
3. Strength Testing with Dynamometry: A Handheld Dynamometer will be used to assess the skeletal muscle strength objectively.
4. Skeletal muscle ultrasonography: will be used to assess the size and thickness of muscles.

B) Training procedures:

All patients in both groups will receive their plan of treatment in addition to the training program for each group as follows:

Group (A) patients in this group will participate in Whole Body Vibration (WBV) training for 2 weeks, two sessions per day (total 14 sessions) in addition to their plan of treatment.

Group (B) patients in this group will participate in neuromuscular electrical stimulation (NMES) training for 2 weeks, two sessions per day ( total 14 sessions), in addition to their plan of treatment.

C) The statistical analysis will be conducted by using the SPSS statistical package program version 25 for Windows (SPSS, Inc., Chicago, IL). Quantitative descriptive statistics data, including the mean and standard deviation, will be used to describe the data. Multivariate analysis of variance (MANOVA) will be used to compare the tested major dependent variables of interest. A mixed-design 2 x 2 MANOVA test will be used to detect within-group changes and between-group differences. The Bonferroni correction test will be used for pairwise comparison within and between groups of the tested dependent variables, whose P-value will be significant from the MANOVA test. The significance level for all statistical analyses will be set at p<0.05.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ICU patients who were aged ≥ 18 and <65.
• Sepsis-related Organ Failure assessments (SOFA) score ≥ 9 within the first 72 h after ICU admission.
• Patients with no central and peripheral nervous system injury.
• Expected to be treated in the ICU for more than 1 week.
• Medical Research Council (MRC) sum score of less than 36/60.
• Dominant-hand handgrip dynamometry scores of less than 11 kg (interquartile range (IQR) 10-40) in males and less than 7 kg (IQR 0-7.3) in females

Exclusion criteria

• Patients with comorbidities interfering with or compromising the training, like cardiac arrhythmia, pericardial effusion, congestive heart failure, or unstable acute coronary syndrome.
• Patients are hemodynamically unstable.
• Patients who had a major neurological deficit (upper motor neuron lesion).
• Age < 18 years and more than 65.
• Implanted pacemaker or defibrillator.
• Pregnancy.
• Unhealed fractures or recently attached implants in the body region to be stimulated.
• Acute venous thrombosis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Group A ( Whole body vibration)

Active Comparator group

Description:

each patient who will practice Whole body vibration for two weeks twice daily in addition to their plan of treatment.

Treatment:

Device: whole body VIBRATION Viberation

Group B (NEURO MUSCULAR ELECTRICAL STIMULATION B )

Active Comparator group

Description:

Each patient will receive neuromuscular electrical stimulation for two weeks, twice daily, in addition to their plan of treatment

Treatment:

Device: Neuro muscular electrical stimulation