The Effect of Neuromuscular Electrical Stimulation
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 11, 2007 | ||||
| Last Updated Date | March 1, 2007 | ||||
| Start Date ICMJE | January 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Perimeter of the right and left thighs was measured in both groups every 3 days at 5 cm above the upp | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00442728 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effect of Neuromuscular Electrical Stimulation | ||||
| Official Title ICMJE | on Muscle Wasting in Artificially Ventilated and Sedated Patients at the Intensive Care Unit: a Pilot Study | ||||
| Brief Summary | The effect of neuromuscular electrical stimulation on muscle atrophy in sedated patients on intensive care was studied. The aim of this study was to explore if electrical stimulation could prevent muscle atrophy. |
||||
| Detailed Description | Patients were included in the study one day after administration when prolonged sedation and ventilation were expected. They were divided into intervention (n=7) and control (n=14) groups. For the intervention group, an intermittent neuromuscular electrical stimulation was applied daily for 30 minutes on the right thigh whereas the left thigh was used as a control. Heart rate, respiration rate, systolic and diastolic blood pressure and oxygen saturation were monitored before, during and after the electrostimulation. Perimeter of the right and left thighs was measured in both groups every 3 days at 5 cm above the upper edge of the kneecap. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Device: ELECTRICAL STIMULATION | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 21 | ||||
| Completion Date | June 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 50 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Belgium | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00442728 | ||||
| Other Study ID Numbers ICMJE | REVAL300107 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Provinciale Hogeschool Limburg | ||||
| Collaborators ICMJE | Katholieke Universiteit Leuven | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Provinciale Hogeschool Limburg | ||||
| Verification Date | March 2007 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||