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Intensive Care PatientsNCT06872697

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

A study testing whole body vibration, Neuromuscular Electrical Stimulation and Conventional Physiotherapy in people with Intensive Care Patients and Whole Body Vibration, run by Istinye University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Intensive Care Patients, Whole Body Vibration
What is being tested?
whole body vibration, Neuromuscular Electrical Stimulation and Conventional Physiotherapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Dec 2024to 25 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 10Show fewer
  • Patients with malignancies,
  • Pregnant individuals,
  • Patients using pacemakers,
  • Patients with high fever.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istınye University

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Whole Body Vibration Application on Muscle Functional Level and Respiratory Parameters in Intensive Care Patients

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.

Read more

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.

Read the 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

Being tested
whole body vibration, Neuromuscular Electrical Stimulation, Conventional Physiotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • whole body vibrationOther

    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.

  • Neuromuscular Electrical StimulationDevice

    Also called electrotherapy

    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 PhysiotherapyOther

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

Study groups in NCT06872697
Study groupRoleWhat they receive
whole body vibration groupExperimentalIn 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.
Receives: Other: whole body vibration; Other: Conventional Physiotherapy
Neuromuscular Electrical Stimulation GroupActive comparatorIn 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.
Receives: Device: Neuromuscular Electrical Stimulation; Other: Conventional Physiotherapy
control groupActive comparatorAs 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.
Receives: Other: Conventional Physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at 4 weeks

  2. Muscle Elasticity Assessment

    Myoton device will be used for the assessment. How the values change according to the application will be examined.

    Measured: 4 weeks

  3. 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.

    Measured: 4 weeks

  4. Grip Strength Assessment

    Grip strength will be measured using a Jamar brand dynamometer. Hand grip strength provides information about overall body muscle strength.

    Measured: 4 weeks

  5. 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

    Measured: 4 weeks

  6. 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.

    Measured: 4 weeks

  7. Functional Status Assessment

    The CPAX is scored from 0 to 50, where higher scores reflect greater independence and physical ability.

    Measured: 4 weeks

  8. Assessment of Inspiratory tidal volume

    Inspiratory tidal volume (TVi) in milliliters in L/min will be recorded.

    Measured: 4 weeks

  9. Assessment of Expiratory tidal volume

    Expiratory tidal volume (TVe) in milliliters in L/min will be recorded.

    Measured: 4 weeks

  10. Assessment of Minute Ventilation

    Minute ventilation in L/min will be recorded.

    Measured: 4 weeks

Secondary outcomes (13)
  1. Assessment of APCAHE II

    APACHE II ranges from 0 to 71, combining physiological, laboratory, and demographic data to predict severity and mortality risk.The higher the APACHE II score, the higher the patient's risk of mortality in the intensive care unit.

    Measured: 4 weeks

  2. Consciousness Level Assessment

    The Glasgow Coma Scale (GCS) will be used to determine the patient's level of consciousness. The Glasgow Coma Scale (GCS) assesses consciousness by evaluating three components: eye opening (4-1), verbal response (5-1), and motor response (6-1). Scores range from 3 (deep coma) to 15 (fully alert), with lower scores indicating more severe impairment. A score of 8 or below typically suggests the need for immediate intervention.

    Measured: 4 weeks

  3. Agitation, Anxiety, and Sedation Assessment

    Agitation and anxiety levels will be assessed using the Richmond Agitation and Sedation Scale (RASS).. Scores range from +4 (combative) to 0 (calm and alert) to -5 (unarousable). Positive scores indicate agitation, 0 indicates normal alertness, and negative scores reflect increasing levels of sedation.

    Measured: 4 weeks

  4. Pain Assessment-The Nonverbal Pain Scale

    The Nonverbal Pain Scale (NVPS) is designed for adults who cannot communicate verbally and evaluates pain based on five categories: facial expression, body movement, muscle tension, compliance with ventilation, and vocalization, each scored from 0 to 2, with a total score ranging from 0 to 10. A score closer to 10 suggests severe pain, while a score closer to 0 indicates minimal or no pain.

    Measured: 4 weeks

  5. Dyspnea Assessment

    Patients will rate their dyspnea by marking a point on a 10 cm horizontal line, where 0 represents no fatigue and 10 indicates the worst fatigue imaginable. The score is determined by measuring the distance from the 0 point to the patient's mark, providing a quantitative measure of dyspnea intensity.

    Measured: 4 weeks

  6. SOFA Assessment

    SOFA evaluates dysfunction in six organ systems, with a total score ranging from 0 to 24, where higher scores indicate greater dysfunction and mortality risk

    Measured: 4 weeks

  7. Pain Assessment-The Visual Analog Scale

    The Visual Analog Scale (VAS) is a self-reported measure where patients mark their pain intensity on a 10 cm line, with 0 indicating no pain and 10 representing the worst pain imaginable.

    Measured: 4 weeks

  8. General Body Fatigue Assessment

    Patients will rate their fatigue by marking a point on a 10 cm horizontal line, where 0 represents no fatigue and 10 indicates the worst fatigue imaginable. The score is determined by measuring the distance from the 0 point to the patient's mark, providing a quantitative measure of fatigue intensity.

    Measured: 4 weeks

  9. Heart Rate Assessment

    The heart rate will be recorded on the monitor at the beginning, end and half an hour after the session.

    Measured: at 4 weeks

  10. Systolic Pressure Assessment

    Systolic pressure will be recorded on the monitor at the beginning, end and half an hour after the session.

    Measured: at 4 weeks

  11. Diastolic Pressure Assessment

    Diastolic Pressure will be recorded on the monitor at the beginning, end and half an hour after the session.

    Measured: at 4 weeks

  12. Oxygen Saturation Assessment

    Oxygen saturation will be recorded on the monitor at the beginning, end and half an hour after the session.

    Measured: at 4 weeks

  13. Respiratory Rate Assessment

    The respiratory rate will be recorded at the beginning, end and half an hour after the session.

    Measured: at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2025
  2. Study start20 Dec 2024
  3. Primary completion15 Feb 2025
  4. Study completion25 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06872697
Sponsor's protocol ID
4/2023.K-11
Status last verified
Mar 2025
First submitted
20 Dec 2024
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Tutuneken YE, Kabasakal E, Kardes K, Karabulut H, Tanriogen B, Senel O, Cagliyan Erdogan H, Isikci B, Parlak H, Yilmaz Yelvar GD, Cirak YB. Effects of whole-body vibration and neuromuscular electrical stimulation on muscle biomechanical properties and thickness in patients in the intensive care unit: a randomized controlled trial. Physiother Theory Pract. 2026 Apr 20:1-11. doi: 10.1080/09593985.2026.2660184. Online ahead of print.

    PubMed 42003288

Questions about this trial

What is this clinical trial studying?

A study testing whole body vibration, Neuromuscular Electrical Stimulation and Conventional Physiotherapy in people with Intensive Care Patients and Whole Body Vibration, run by Istinye University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Muscle Thickness (time frame: at 4 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06872697, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

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