Clinical Trials Directory

Trials / Completed

CompletedNCT01286610

Applicability and Safety of Vibration Therapy in Intensive Care Unit (ICU) Patients

Application of Vibration Therapy as a Measure of Muscle Activation in ICU Patients and Its Effect on Hemodynamics, Intracranial Pressure as Well as Energy Metabolism

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Charite University, Berlin, Germany · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Vibration therapy is used for different indications in rehabilitation and sports medicine. So far, vibration therapy has not been investigated within the ICU setting. The investigators created this setting to show safety and applicability of vibration therapy in ICU patients. 30 patients will be stimulated by vibration therapy on two separate days during their ICU stay. Three collectives of equal size will be observed: One with patients on mechanical ventilation without signs of infection or suspected intracranial pressure problems, a second one with patients on mechanical ventilation in addition to signs of systemic inflammation but absence of suspected intracranial pressure problems, and a third one with patients on mechanical ventilation, signs of systemic inflammation in addition to presence of controlled intracranial pressure problems. Typical parameters of hemodynamic status, intracranial pressure and energy metabolism will be recorded for a defined period of time before, during and after vibration therapy itself. Vibration therapy will be combined with protocol based physiotherapy. Our aim is to show the effects of vibration therapy in ICU patients and its safe applicability. ADDITION 06th of May 2011: Additionally we will perform euglycaemic hyperinsulinemic clamp and intervention on one day of ICU stay in 20 patients. Under clamp conditions we will perform a vibration therapy (ProMedVi Vibrosphere™) on patients' legs. On top we will perform electrical muscle stimulation (schwa-medico, MUSKELaktiv™) on one ventral upper leg, randomized chosen. Measuring the local skeletal muscle metabolism will be done by microdialysis in Vastus lateralis on both sides - comparing vibration therapy and vibration therapy combined with electrical muscle stimulation.

Conditions

Interventions

TypeNameDescription
DEVICEProMedVi Vibrospherevibration therapy
DEVICEschwa-medico MUSKELaktivElectrical muscle stimulation
DEVICEGalileo Home Plus (ICU)vibration therapy

Timeline

Start date
2011-02-01
Primary completion
2012-01-01
Completion
2012-05-01
First posted
2011-01-31
Last updated
2017-02-09

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT01286610. Inclusion in this directory is not an endorsement.