Impact of Whole Body Vibration on Muscle Function and Respiratory Parameters in Intensive Care Patients

The Effect of Whole Body Vibration Application on Muscle Functional Level and Respiratory Parameters in Intensive Care Patients

Immobility and mechanical ventilation in intensive care unit (ICU) patients lead to muscle weakness and loss, particularly in antigravity and respiratory muscles. Early physiotherapy interventions are crucial to prevent complications, reduce side effects, shorten intubation time, and lower patient costs. ICU physiotherapy includes chest physiotherapy, range of motion exercises, strengthening exercises, mobilization, positioning, and inspiratory/peripheral muscle training.

Muscle training plays a key role in ICU physiotherapy. Whole Body Vibration (WBV) is a promising, side-effect-free intervention to enhance muscle strength in various populations. Its effects result from neuromuscular responses to mechanical vibrations and the tonic vibration reflex. WBV has been reported to improve muscle strength, elasticity, circulation, and balance while reducing pain and fall risk. However, its effects on ICU patients remain unclear. To date, only one study has shown increased muscle electrical activity in ICU patients after WBV, but no research has evaluated changes in muscle strength, mass, or elasticity.

Another method used in muscle training is neuromuscular electrical stimulation (NMES), which prevents muscle atrophy, strengthens muscles, and restores endurance. NMES is suitable for patients with limited cooperation, making it an alternative to active exercise. No study has compared NMES and WBV in immobile ICU patients. Given the limited non-pharmacological options in ICU care, particularly for unconscious or uncooperative patients, identifying effective alternatives is essential.

This study aims to compare the effects of WBV and NMES on respiratory muscle strength, respiratory parameters, and muscle mass, composition, elasticity, and strength in ICU patients. Participants will be divided into three groups: WBV (n=15), NMES (n=15), and conventional therapy only (n=15). All groups will receive conventional therapy five days a week for four weeks, with WBV added to the first group and NMES to the second. Functional status, muscle assessments, grip strength, respiratory muscle strength, and respiratory parameters will be evaluated at baseline and study completion.

The findings will provide objective data on the effectiveness of WBV and NMES in ICU patients, guiding future research and treatment while contributing to national and international literature.

Study Overview

• Status: Completed
• Conditions: Whole Body Vibration; Intensive Care Patients
• Intervention / Treatment: Other: whole body vibration; Other: Conventional Physiotherapy; Device: Neuromuscular Electrical Stimulation

Detailed Description

This randomized controlled trial will investigate and compare the effects of WBV and NMES on respiratory muscle strength, respiratory parameters, and muscle mass, composition, elasticity, and strength in ICU patients. A total of 45 patients will be randomly assigned to one of three groups:

WBV Group (n=15): Conventional therapy + Whole Body Vibration NMES Group (n=15): Conventional therapy + Neuromuscular Electrical Stimulation Control Group (n=15): Conventional therapy only

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istınye University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged between 18 and 80 years,
• Clinically stable condition,
• Deemed suitable for physiotherapy interventions by the intensive care specialist physician,
• Willing to participate in the study or, if unconscious, authorized by a first-degree relative.

Exclusion Criteria:

• Patients with coagulation disorders (Prothrombin Time (PT); International Normalized Ratio (INR) value greater than 1.5, and platelet count less than 50,000/mm³),
• Agitated patients (Richmond Agitation and Sedation Scale (RASS) score ≥ 2)
• Patients with signs of increased intracranial pressure,
• Patients with cardiac and respiratory instability (respiratory rate above 30 breaths/min, systolic blood pressure below 80 mmHg or above 200 mmHg, diastolic blood pressure below 50 mmHg or above 100 mmHg, PaO₂ < 65 mmHg, FiO₂ > 55%),
• Patients with hemodynamic instability (requiring dopamine support > 5 mcg/kg/min),
• Patients in shock,
• Patients with malignancies,
• Pregnant individuals,
• Patients using pacemakers,
• Patients with high fever.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: whole body vibration group; In the group receiving whole-body vibration in addition to conventional treatment, the whole-body vibration will be performed with the patient's hips and knees in approximately 20° flexion, and the bed inclined to 25-30°. The vibration platform will be fixed at the end of the bed, and the patients will apply pressure with their feet on the platform. The whole-body vibration will be administered for 3 minutes, 1-4 sets, at a frequency of 20-25 Hz, 5 days a week, for 4 weeks.	Other: whole body vibration; In the group receiving whole-body vibration in addition to conventional treatment, the whole-body vibration will be performed with the patient's hips and knees in approximately 20° flexion, and the bed inclined to 25-30°. The vibration platform will be fixed at the end of the bed, and the patients will apply pressure with their feet on the platform. The whole-body vibration will be administered for 3 minutes, 1-4 sets, at a frequency of 20-25 Hz, 5 days a week, for 4 weeks, depending on the protocol, in addition to conventional physiotherapy.; Other: Conventional Physiotherapy; The conventional treatment program will include normal range of motion, airway clearance techniques, breathing exercises, and mobilization.
Active Comparator: Neuromuscular Electrical Stimulation Group; In addition to conventional treatment, low-frequency neuromuscular electrical stimulation with a symmetrical biphasic waveform at 50 Hz will be applied to the biceps brachii and quadriceps femoris muscles for 45 minutes per session, 5 days a week, for 4 weeks.	Other: Conventional Physiotherapy; The conventional treatment program will include normal range of motion, airway clearance techniques, breathing exercises, and mobilization.; Device: Neuromuscular Electrical Stimulation; In this group, neuromuscular electrical stimulation (NMES) will be applied to the targeted muscle groups. The application will be carried out with the patient in a comfortable seated or lying position. Stimulation parameters will be set as follows: a frequency of 35-50 Hz, a pulse duration of 200-400 microseconds, and an intensity adjusted to elicit visible muscle contractions without causing discomfort. NMES will be applied for 20-30 minutes per session, 3-5 times a week, for 4-6 weeks, depending on the protocol, in addition to conventional physiotherapy.; Other Names: electrotherapy
Active Comparator: control group; As conventional treatment (CT), normal range of motion exercises, airway clearance techniques, breathing exercises, and mobilization will be applied 5 days a week for 4 weeks.	Other: Conventional Physiotherapy; The conventional treatment program will include normal range of motion, airway clearance techniques, breathing exercises, and mobilization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of Muscle Thickness	The patient's muscle thickness is evaluated with the EDAN DUS 60 ultrasonography device, and the increase in muscle thickness is measured.	at 4 weeks
Muscle Elasticity Assessment	Myoton device will be used for the assessment. How the values change according to the application will be examined.	4 weeks
Muscle Strength Assessment	Muscle strength will be objectively measured using a myometer in conjunction with the Medical Research Council (MRC) scale. Each muscle group is assessed on a scale from 0 (no movement or complete paralysis) to 5 (full normal strength). The cumulative MRC scale score ranges from 0 to 60, with a score below 48 indicating the presence of muscle weakness.	4 weeks
Grip Strength Assessment	Grip strength will be measured using a Jamar brand dynamometer. Hand grip strength provides information about overall body muscle strength.	4 weeks
Measurement of Respiratory Muscle Strength	To measure respiratory muscle strength, patients connected to mechanical ventilation will be switched to the CPAP mode of the ventilator. The ventilator settings will be adjusted to PEEP: 5 cmH2O and Psup: 10 cmH2O to overcome the physiological resistance of the ventilator circuit. The pressure value displayed on the mechanical ventilator screen will be recorded as the MIB value	4 weeks
Functional Status Assessment	The Premorbid Activity Level Scale will be used to determine the patient's functional status in daily life prior to intensive care. This scale categorizes activity levels from 0 (completely dependent) to 4 (independent in all activities). . The P-FIT is scored from 0 to 12, with higher scores indicating better physical function.	4 weeks
Functional Status Assessment	The CPAX is scored from 0 to 50, where higher scores reflect greater independence and physical ability.	4 weeks
Assessment of Inspiratory tidal volume	Inspiratory tidal volume (TVi) in milliliters in L/min will be recorded.	4 weeks
Assessment of Expiratory tidal volume	Expiratory tidal volume (TVe) in milliliters in L/min will be recorded.	4 weeks
Assessment of Minute Ventilation	Minute ventilation in L/min will be recorded.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of APCAHE II	APACHE II ranges from 0 to 71, combining physiological, laboratory, and demographic data to predict severity and mortality risk.The higher the APACHE II score, the higher the patient's risk of mortality in the intensive care unit.	4 weeks
Consciousness Level Assessment	The Glasgow Coma Scale (GCS) will be used to determine the patient's level of consciousness. The Glasgow Coma Scale (GCS) assesses consciousness by evaluating three components: eye opening (4-1), verbal response (5-1), and motor response (6-1). Scores range from 3 (deep coma) to 15 (fully alert), with lower scores indicating more severe impairment. A score of 8 or below typically suggests the need for immediate intervention.	4 weeks
Agitation, Anxiety, and Sedation Assessment	Agitation and anxiety levels will be assessed using the Richmond Agitation and Sedation Scale (RASS).. Scores range from +4 (combative) to 0 (calm and alert) to -5 (unarousable). Positive scores indicate agitation, 0 indicates normal alertness, and negative scores reflect increasing levels of sedation.	4 weeks
Pain Assessment-The Nonverbal Pain Scale	The Nonverbal Pain Scale (NVPS) is designed for adults who cannot communicate verbally and evaluates pain based on five categories: facial expression, body movement, muscle tension, compliance with ventilation, and vocalization, each scored from 0 to 2, with a total score ranging from 0 to 10. A score closer to 10 suggests severe pain, while a score closer to 0 indicates minimal or no pain.	4 weeks
Dyspnea Assessment	Patients will rate their dyspnea by marking a point on a 10 cm horizontal line, where 0 represents no fatigue and 10 indicates the worst fatigue imaginable. The score is determined by measuring the distance from the 0 point to the patient's mark, providing a quantitative measure of dyspnea intensity.	4 weeks
SOFA Assessment	SOFA evaluates dysfunction in six organ systems, with a total score ranging from 0 to 24, where higher scores indicate greater dysfunction and mortality risk	4 weeks
Pain Assessment-The Visual Analog Scale	The Visual Analog Scale (VAS) is a self-reported measure where patients mark their pain intensity on a 10 cm line, with 0 indicating no pain and 10 representing the worst pain imaginable.	4 weeks
General Body Fatigue Assessment	Patients will rate their fatigue by marking a point on a 10 cm horizontal line, where 0 represents no fatigue and 10 indicates the worst fatigue imaginable. The score is determined by measuring the distance from the 0 point to the patient's mark, providing a quantitative measure of fatigue intensity.	4 weeks
Heart Rate Assessment	The heart rate will be recorded on the monitor at the beginning, end and half an hour after the session.	at 4 weeks
Oxygen Saturation Assessment	Oxygen saturation will be recorded on the monitor at the beginning, end and half an hour after the session.	at 4 weeks
Respiratory Rate Assessment	The respiratory rate will be recorded at the beginning, end and half an hour after the session.	at 4 weeks
Systolic Pressure Assessment	Systolic pressure will be recorded on the monitor at the beginning, end and half an hour after the session.	at 4 weeks
Diastolic Pressure Assessment	Diastolic Pressure will be recorded on the monitor at the beginning, end and half an hour after the session.	at 4 weeks

Collaborators and Investigators

• Sponsor: Istinye University

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2024
• Primary Completion (Actual): February 15, 2025
• Study Completion (Actual): March 25, 2025

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: March 7, 2025
• First Posted (Actual): March 12, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 4/2023.K-11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No