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NCT Number: NCT06872697

Impact of Whole Body Vibration on Muscle Function 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.

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Key information

Conditions

Intensive Care Patients Whole Body Vibration

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istınye University

Istanbul, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whole body vibration

Other

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.

Neuromuscular Electrical Stimulation

Device

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

Conventional Physiotherapy

Other

The conventional treatment program will include normal range of motion, airway clearance techniques, breathing exercises, and mobilization.

Primary outcomes

  1. Evaluation of Muscle Thickness

    Time frame: at 4 weeks

    The patient's muscle thickness is evaluated with the EDAN DUS 60 ultrasonography device, and the increase in muscle thickness is measured.

  2. Muscle Elasticity Assessment

    Time frame: 4 weeks

    Myoton device will be used for the assessment. How the values change according to the application will be examined.

  3. Muscle Strength Assessment

    Time frame: 4 weeks

    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. Grip Strength Assessment

    Time frame: 4 weeks

    Grip strength will be measured using a Jamar brand dynamometer. Hand grip strength provides information about overall body muscle strength.

  5. Measurement of Respiratory Muscle Strength

    Time frame: 4 weeks

    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

  6. Functional Status Assessment

    Time frame: 4 weeks

    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.

  7. Functional Status Assessment

    Time frame: 4 weeks

    The CPAX is scored from 0 to 50, where higher scores reflect greater independence and physical ability.

  8. Assessment of Inspiratory tidal volume

    Time frame: 4 weeks

    Inspiratory tidal volume (TVi) in milliliters in L/min will be recorded.

  9. Assessment of Expiratory tidal volume

    Time frame: 4 weeks

    Expiratory tidal volume (TVe) in milliliters in L/min will be recorded.

  10. Assessment of Minute Ventilation

    Time frame: 4 weeks

    Minute ventilation in L/min will be recorded.

Secondary outcomes

  1. Assessment of APCAHE II

    Time frame: 4 weeks

    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.

  2. Consciousness Level Assessment

    Time frame: 4 weeks

    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.

  3. Agitation, Anxiety, and Sedation Assessment

    Time frame: 4 weeks

    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. Pain Assessment-The Nonverbal Pain Scale

    Time frame: 4 weeks

    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.

  5. Dyspnea Assessment

    Time frame: 4 weeks

    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.

  6. SOFA Assessment

    Time frame: 4 weeks

    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

  7. Pain Assessment-The Visual Analog Scale

    Time frame: 4 weeks

    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.

  8. General Body Fatigue Assessment

    Time frame: 4 weeks

    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.

  9. Heart Rate Assessment

    Time frame: at 4 weeks

    The heart rate will be recorded on the monitor at the beginning, end and half an hour after the session.

  10. Systolic Pressure Assessment

    Time frame: at 4 weeks

    Systolic pressure will be recorded on the monitor at the beginning, end and half an hour after the session.

  11. Diastolic Pressure Assessment

    Time frame: at 4 weeks

    Diastolic Pressure will be recorded on the monitor at the beginning, end and half an hour after the session.

  12. Oxygen Saturation Assessment

    Time frame: at 4 weeks

    Oxygen saturation will be recorded on the monitor at the beginning, end and half an hour after the session.

  13. Respiratory Rate Assessment

    Time frame: at 4 weeks

    The respiratory rate will be recorded at the beginning, end and half an hour after the session.

Sponsors and collaborators

Lead sponsor

Istinye University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2025
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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