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

NCT06872697 | Completed

• 1 other identifier: 4/2023.K-11
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intensive Care Patients; Whole Body Vibration

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (13)

• Assessment of APCAHE II

  4 weeks

• Consciousness Level Assessment

  4 weeks

• Agitation, Anxiety, and Sedation Assessment

  4 weeks

• Pain Assessment-The Nonverbal Pain Scale

  4 weeks

• Dyspnea Assessment

  4 weeks

Study Arms (3)

whole body vibration group

EXPERIMENTAL

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; Other: Conventional Physiotherapy

Neuromuscular Electrical Stimulation Group

ACTIVE COMPARATOR

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.

Device: Neuromuscular Electrical Stimulation; Other: Conventional Physiotherapy

control group

ACTIVE COMPARATOR

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

Interventions

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.

whole body vibration group

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.

Also known as: electrotherapy

Neuromuscular Electrical Stimulation Group

Conventional Physiotherapy OTHER

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

Neuromuscular Electrical Stimulation Group; control group; whole body vibration group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istinye University: lead

Study Sites (1)

Istınye University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Electric Stimulation Therapy

Intervention Hierarchy (Ancestors)

Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LECTURER

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: March 12, 2025
• Study Start: December 20, 2024
• Primary Completion: February 15, 2025
• Study Completion: March 25, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

TU (1)