Early Mobilization in Intensive Therapy (MIT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Region Zealand.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Capital Region
Information provided by (Responsible Party):
Anne Skafte, Region Sealand
ClinicalTrials.gov Identifier:
NCT01549808
First received: March 6, 2012
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

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 Intervention Phase
Critical Illness
Other: mobilization
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Early Mobilisation in Intensive Therapy

Further study details as provided by Region Zealand:

Primary Outcome Measures:
  • The primary outcome is to measure the functional ability of the patients [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Is to measure the effect of mobilization related to time in hospital [ Time Frame: 2. year ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 200
Study Start Date: February 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: group 2

Participants:

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:

  1. An 8 month observation phase.Current practice relatede to mobilize is measured.
  2. An 2 month implementation phase and third: an 8 month intervention phase. The effect is measured as the difference in the functional level between the observation phase and the intervention phase related to primary and secondary outcome.

The effect of the intervention is described by using following test:

walking distance,ADL function, capability to sit and stand

Other: mobilization
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.
Other: mobilization
sitting, standing and walking

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Patients who will be included:

  • 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.

Patients who will be excluded:

  • Patients with a terminal illness,
  • users of wheelchairs,
  • patients with a known cognitive disturbance,
  • open thorax,
  • ECMO,
  • VAD,
  • IABP,
  • patient who is not allowed to mobilizing during their stay in ICU, and finally
  • patients living outside Sjaelland, Lolland and Falster.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549808

Contacts
Contact: Anne Skafte, Nurse +45 58559232 aask@regionsaelland.dk
Contact: Anne Langvad, nurse +4535458751 anne.langvad@rh.regionh.dk

Locations
Denmark
Slagelse Sygehus, intensiv afdeling Recruiting
Slagelse, Denmark, 4200
Contact: Anne Skafte, MKS    +45 58559232    aask@regionsjaelland.dk   
Principal Investigator: Dorthe Larsen, Master         
Principal Investigator: Anne Langvad, Master         
Principal Investigator: Suzanna Fragtrup, nurse         
Principal Investigator: Tina Hartley, nurse         
Sponsors and Collaborators
Region Zealand
Capital Region
Investigators
Principal Investigator: Anne Skafte, Nurse Slagelse Sygehus, Danmark
  More Information

No publications provided

Responsible Party: Anne Skafte, Nurse, Region Sealand
ClinicalTrials.gov Identifier: NCT01549808     History of Changes
Other Study ID Numbers: MIT ITA SLS 4141RH
Study First Received: March 6, 2012
Last Updated: March 8, 2012
Health Authority: Denmark: Ethics Committee

Keywords provided by Region Zealand:
ADL
activities of daily living
level of function

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014