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

NCT ID: NCT06872697

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-20
• Study Completion Date: 2025-03-25

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.

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

Conditions

Intensive Care Patients; Whole Body Vibration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

whole body vibration

Intervention Type: 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.

Conventional Physiotherapy

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Neuromuscular Electrical Stimulation

Intervention Type: 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.

Conventional Physiotherapy

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Conventional Physiotherapy

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

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.

Intervention Type: DEVICE

Conventional Physiotherapy

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

Intervention Type: OTHER

Other Intervention Names

electrotherapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istinye University

OTHER

Sponsor Role: lead

Responsible Party

Elif Kabasakal

LECTURER

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istınye University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

4/2023.K-11

Identifier Type: -

Identifier Source: org_study_id