The Effect of Whole Body Vibration Application on Muscle Functional Level and Respiratory Parameters in Intensive Care Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Functional Status Assessment
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: whole body vibration (Other)
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.
干预措施: Conventional Physiotherapy (Other)
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.
干预措施: Neuromuscular Electrical Stimulation (Device)
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.
干预措施: Conventional Physiotherapy (Other)
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.
干预措施: Conventional Physiotherapy (Other)
结局指标
主要结局
Functional Status Assessment
时间窗: 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.
Muscle Elasticity Assessment
时间窗: 4 weeks
Myoton device will be used for the assessment. How the values change according to the application will be examined.
Evaluation of Muscle Thickness
时间窗: 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.
Muscle Strength Assessment
时间窗: 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.
Grip Strength Assessment
时间窗: 4 weeks
Grip strength will be measured using a Jamar brand dynamometer. Hand grip strength provides information about overall body muscle strength.
Measurement of Respiratory Muscle Strength
时间窗: 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
Assessment of Inspiratory tidal volume
时间窗: 4 weeks
Inspiratory tidal volume (TVi) in milliliters in L/min will be recorded.
Assessment of Expiratory tidal volume
时间窗: 4 weeks
Expiratory tidal volume (TVe) in milliliters in L/min will be recorded.
Assessment of Minute Ventilation
时间窗: 4 weeks
Minute ventilation in L/min will be recorded.
次要结局
- Assessment of APCAHE II(4 weeks)
- Agitation, Anxiety, and Sedation Assessment(4 weeks)
- Consciousness Level Assessment(4 weeks)
- Pain Assessment-The Nonverbal Pain Scale(4 weeks)
- Dyspnea Assessment(4 weeks)
- SOFA Assessment(4 weeks)
- Pain Assessment-The Visual Analog Scale(4 weeks)
- General Body Fatigue Assessment(4 weeks)
- Heart Rate Assessment(at 4 weeks)
- Systolic Pressure Assessment(at 4 weeks)
- Diastolic Pressure Assessment(at 4 weeks)
- Oxygen Saturation Assessment(at 4 weeks)
- Respiratory Rate Assessment(at 4 weeks)
研究者
Elif Kabasakal
LECTURER
Istinye University