Clinical trial NCT06872697: Impact of Whole Body Vibration on Muscle Function and Respiratory Parameters in Intensive Care Patients
Official title: The Effect of Whole Body Vibration Application on Muscle Functional Level and Respiratory Parameters in Intensive Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Patients
Whole Body Vibration
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Evaluation of Muscle Thickness
timeFrame: at 4 weeks
measure: Muscle Elasticity Assessment
timeFrame: 4 weeks
measure: Muscle Strength Assessment
timeFrame: 4 weeks
measure: Grip Strength Assessment
timeFrame: 4 weeks
measure: Measurement of Respiratory Muscle Strength
timeFrame: 4 weeks
measure: Functional Status Assessment
timeFrame: 4 weeks
measure: Functional Status Assessment
timeFrame: 4 weeks
measure: Assessment of Inspiratory tidal volume
timeFrame: 4 weeks
measure: Assessment of Expiratory tidal volume
timeFrame: 4 weeks
measure: Assessment of Minute Ventilation
timeFrame: 4 weeks
Secondary outcomes:
measure: Assessment of APCAHE II
timeFrame: 4 weeks
measure: Consciousness Level Assessment
timeFrame: 4 weeks
measure: Agitation, Anxiety, and Sedation Assessment
timeFrame: 4 weeks
measure: Pain Assessment-The Nonverbal Pain Scale
timeFrame: 4 weeks
measure: Dyspnea Assessment
timeFrame: 4 weeks
measure: SOFA Assessment
timeFrame: 4 weeks
measure: Pain Assessment-The Visual Analog Scale
timeFrame: 4 weeks
measure: General Body Fatigue Assessment
timeFrame: 4 weeks
measure: Heart Rate Assessment
timeFrame: at 4 weeks
measure: Systolic Pressure Assessment
timeFrame: at 4 weeks
measure: Diastolic Pressure Assessment
timeFrame: at 4 weeks
measure: Oxygen Saturation Assessment
timeFrame: at 4 weeks
measure: Respiratory Rate Assessment
timeFrame: at 4 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istınye University
Study officials:
References: