Early Mobilization in Intensive Therapy

NCT01549808 | Unknown Phase 1

• 1 other identifier: MIT ITA SLS 4141RH
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critical Illness

Keywords

ADL; activities of daily living; level of function

Outcome Measures

Primary Outcomes (1)

• The primary outcome is to measure the functional ability of the patients

  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.

  3 years

Secondary Outcomes (1)

• Is to measure the effect of mobilization related to time in hospital

  2. year

Study Arms (1)

group 2

EXPERIMENTAL

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

Interventions

mobilization OTHER

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.

group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Region Zealand: lead
• Capital Region: collaborator

Study Sites (1)

Slagelse Sygehus, intensiv afdeling

Slagelse, 4200, Denmark

RECRUITING

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne Skafte, Nurse

  Slagelse Sygehus, Danmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Skafte, Nurse

CONTACT

+45 58559232; aask@regionsaelland.dk

Anne Langvad, nurse

CONTACT

+4535458751; anne.langvad@rh.regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nurse

Study Record Dates

• First Submitted: March 6, 2012
• First Posted: March 9, 2012
• Study Start: February 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 9, 2012

Record last verified: 2012-03

Locations

DK (1)