Early Mobilization in Intensive Therapy (MIT)
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|ClinicalTrials.gov Identifier: NCT01549808|
Recruitment Status : Unknown
Verified March 2012 by Anne Skafte, Region Zealand.
Recruitment status was: Recruiting
First Posted : March 9, 2012
Last Update Posted : March 9, 2012
Abstract Many patients experience serious reduced functional ability after a critical illness and hospitalization in an Intensive Care Unit. The cause of the reduced functional ability is the combination of critical illness and immobilization following treatment with a ventilator. The functional ability of patients can be affected up till a year after the discharge, and may shows a decrease in ability to walk and in problems with focusing.
Studies show that it is safe and possible to mobilize the patients with for instance bed bikes, sitting up and standing up, even during ventilator therapy. The effect is shown as lesser days with delirium, on a ventilator therapy or hospitalization. No study has shown how early and at which intensity a patient can be mobilized. Our hypothesis is that an early systematic mobilization improves functional ability of the critically ill patient, mentally, physically and their life expectancy. The purpose of this study is to evaluate a mobilization protocol applied at critically ill patients, including a contribute related to knowledge of how soon and how intense patients ventilated for more than 48 hours can endure mobilization. To evaluate the connections between functional ability and life expectancy for critically ill patients are compared to a population matching in age.
This intervention project has a multicenter design with pre- and post research related to effect in early systematic mobilization of critically ill patients. 200 patients are included in the project.
Data are collected at tests showing the functional ability of patients in different ways. The tests are made at the discharge from the Intensive Care Unit and 5 days after at their wards and again at 3 and 12 month from discharge when the patients have returned to their home. The project started in February 2011 and is expected to end in May 2013, findings is expected in November 2013.
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness||Other: mobilization||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early Mobilisation in Intensive Therapy|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||April 2014|
Experimental: group 2
100 patients will be included in the observation phase of this project, and another 100 in the intervention phase, according to the following criteria: Patients hospitalized in Unit 4141, at Rigshospitalet or ICU at Slagelse, who have been intubated for more than 48 hours, age ≥18, and after positive confirmation from relatives that the patient before the hospitalization was able to read and understand instructions.
The research is divided in 3 phases:
The effect of the intervention is described by using following test:
walking distance,ADL function, capability to sit and stand
The patients are mobilized according to the mobilization protocol. The training concist of balance, muscle strength and staying power. Before the mobilization the patients ability to mobilization is evaluated according to contradictions and pre screening (exh 2,3). The primary nurse and the physiotherapist evaluate and allocate patients to mobilization stage. All patients is mobilized minimum 3 times at day (exh 2) and is supported as a minimum of two persons. Before each activity the patient must have a rest period of ½ hour. The patients security during mobilization is registried (exh 1,3). The mobilization stops if patients security is affected. During walk patients is followed by a chair, in order to prevent or cushion a fall.
sitting, standing and walking
- The primary outcome is to measure the functional ability of the patients [ Time Frame: 3 years ]The primary outcome is to measure the functional ability of the patients related to systematic mobilization. The patients stamina, balance, strength, experience and sense of control and emotional energy in relation to social contact is also measured. Correlation between functional ability and life expectancy is measured through their own judgment in relation to their physical level of activity, before hospitalisation and after discharge.
- Is to measure the effect of mobilization related to time in hospital [ Time Frame: 2. year ]The secondary outcome is to measure mortality, days with mechanical ventilation, number of days of delirium, and bed rest at the Intensive Care Units and in the hospital, and factors contributing to critical illness which could influence the patients ability to recover (viewed as mobilization) are also measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549808
|Contact: Anne Skafte, Nurse||+45 firstname.lastname@example.org|
|Contact: Anne Langvad, email@example.com|
|Slagelse Sygehus, intensiv afdeling||Recruiting|
|Slagelse, Denmark, 4200|
|Contact: Anne Skafte, MKS +45 58559232 firstname.lastname@example.org|
|Principal Investigator: Dorthe Larsen, Master|
|Principal Investigator: Anne Langvad, Master|
|Principal Investigator: Suzanna Fragtrup, nurse|
|Principal Investigator: Tina Hartley, nurse|
|Principal Investigator:||Anne Skafte, Nurse||Slagelse Sygehus, Danmark|