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

Istinye University

Status: Completed

Conditions: Whole Body Vibration; Intensive Care Patients

Treatments: Other: Conventional Physiotherapy; Other: whole body vibration; Device: Neuromuscular Electrical Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06872697

4/2023.K-11

Details and patient eligibility

About

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.

Full 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

Enrollment: 45 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

whole body vibration group

Experimental group

Description:

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.

Treatment:

Other: whole body vibration

Other: Conventional Physiotherapy

Neuromuscular Electrical Stimulation Group

Active Comparator group

Description:

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.

Treatment:

Device: Neuromuscular Electrical Stimulation

Other: Conventional Physiotherapy

control group

Active Comparator group

Description:

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.

Treatment:

Other: Conventional Physiotherapy