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Being Awake, Upright and Moving as the Basis for Early ICU Physiotherapy

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ClinicalTrials.gov Identifier: NCT02301273
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : November 30, 2015
Sponsor:
Collaborator:
University of Iceland
Information provided by (Responsible Party):
Olof Ragna Amundadottir, Landspitali University Hospital

Brief Summary:

Patients who have been admitted to Intensive Care Units (ICU) and are intubated and mechanically ventilated for longer than 48 hours have impaired physical, psychological and social health and well-being six to twelve months after discharge. The advocacy of intensive physiotherapy and mobilization early in the course of critical illness has been established. It is of great importance to study the long-term outcomes (physical function and quality of life) in intubated and ventilated patients who start exercising and ambulating mobilizing) as soon as possible during ICU stay because the most effective mode, intensity or frequency of exercise needs to be identified.

The aim is to study the short- and long-term outcomes of enhanced early physiotherapy and upright position in critically ill patients on prolonged invasive ventilation and to develop principles to guide physiotherapists in their clinical decision making in the ICU.


Condition or disease Intervention/treatment Phase
Critical Illness Other: Usual Physiotherapy Other: Enhanced Physiotherapy Not Applicable

Detailed Description:
Mobilization is an intervention prescribed by physiotherapists, for critically ill patients in the ICU, to prevent as well as remediate a range of multisystem problems and complications. Mobilization which refers to low levels of exercise and progressive position changes from being supine to being upright and moving, is both a gravitational and an exercise stimulus. Given the hemodynamic status of patients in the ICU can change suddenly, physiotherapists gauge the patient's status moment by moment, and change the parameters of an intervention accordingly, i.e., the type and level of an intervention, its duration and rest periods. The aim of this research is to study the short- and long-term outcomes of enhanced early physiotherapy, with mobilization and upright position, in critically ill patients on prolonged invasive ventilation. This is a prospective, randomized, single blind trial where the intervention permits variation in the physiotherapist's clinical decision making to simulate the general practice. This study started in November 2011, data collection and intervention will continue until November 2014 with 12 months follow up until november 2015.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Being Awake, Upright and Moving as the Basis for Early ICU Physiotherapy: Comparison of Patient Outcomes Between Enhanced and Conventional ICU Physiotherapy
Study Start Date : November 2011
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
Active Comparator: Usual Physiotherapy
Patients will receive the usual physiotherapy treatment in ICU in Iceland from day 5 after intubation, which adheres to international standards of practice, including the potential for no treatment. Usual physiotherapy once daily for 20 minutes.
Other: Usual Physiotherapy
o Patients will receive the usual physiotherapy treatment in ICU in Iceland from day 5 after intubation, which adheres to international standards of practice, including the potential for no treatment. Usual physiotherapy once daily for 20 minutes.
Other Names:
  • Intensive care unit
  • Physiotherapy
  • Long term follow up of ICU survivors

Experimental: Enhanced Physiotherapy
Patients will receive the intervention physiotherapy treatment consisting of exercises and a progressive upright positioning and mobilization (20 minutes) twice daily from day 3 (>48 hours) after intubation including the potential for no treatment, if they are stable, even though they are not completely alert, Total treatment time of 40 minutes.
Other: Enhanced Physiotherapy
o Patients will receive the intervention physiotherapy treatment consisting of exercises and a progressive upright positioning and mobilization (20 minutes) twice daily from day 3 (>48 hours) after intubation including the potential for no treatment, if they are stable, even though they are not completely alert, Total treatment time of 40 minutes.
Other Names:
  • Intensive care unit
  • Physiotherapy
  • Upright position
  • Exercise
  • Long term follow up of ICU survivors




Primary Outcome Measures :
  1. Length of ICU and hospital stay [ Time Frame: ICU discharge an expected average of 7 days / hospital discharge an expected average of 21 days ]
    Length of ICU and hospital stay will be measured in days and hours


Secondary Outcome Measures :
  1. Physical Function [ Time Frame: ICU discharge an expected average of 7 days / hospital discharge an expected average of 21 days and 3, 6 and 12 months after ICU discharge ]
    Medical Research Council - sum-score

  2. Physical function [ Time Frame: ICU discharge an expected average of 7 days / hospital discharge an expected average of 21 days and 3, 6 and 12 months after ICU discharge ]
    Modified Barthel Index

  3. Physical function [ Time Frame: 3,6,12 months after discharge from ICU ]
    6 min walk test,

  4. Health Related Quality of Life [ Time Frame: 0,3,6,12 months after discharge from ICU ]
    Short Form-36v2,



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient participants will be at least 18 years of age and admitted to the ICU of Landspitali Fossvogur or Landspitali Hringbraut of the The National University Hospital of Iceland.
  • Intubated and on mechanical ventilation for > 48 hours
  • Icelandic speaking.
  • Upright position and ambulation is not contraindicated or impossible.

Exclusion Criteria:

-Those patients deemed by the medical teams of each unit not to be sufficiently stable. These would include diagnoses such as: Intracranial insults including:Severe head injury, Subarachnoidal hemorrhage, Elevated intracranial pressure, Intraventricular drain, Neurological deterioration, Status epileptics

  • Unstable fractures of the vertebral column
  • Spinal cord injuries
  • Unstable pelvic fractures and/or balanced skeletal traction
  • Severe burns
  • Mental status precluding being able to follow instructions and cooperate with treatment appropriately

Information from the National Library of Medicine

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): NCT02301273


Locations
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Iceland
Landspítali University Hospital
Reykjavík, Iceland, 108
Sponsors and Collaborators
Landspitali University Hospital
University of Iceland
Investigators
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Study Chair: Elizabeth Dean, PhD University of Iceland
Study Chair: Gísli H Sigurðsson, PhD Landspítali University Hospital and University of Iceland
Study Chair: Þórarinn Sveinsson, PhD University of Iceland
Study Chair: Helga Jónsdóttir, PhD University of Iceland
Study Chair: Alma Möller, PhD Landspítali University Hospital

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Responsible Party: Olof Ragna Amundadottir, Principal Investigator, Landspitali University Hospital
ClinicalTrials.gov Identifier: NCT02301273     History of Changes
Other Study ID Numbers: 16.2011
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: November 30, 2015
Last Verified: November 2015

Keywords provided by Olof Ragna Amundadottir, Landspitali University Hospital:
Intensive care unit
Physiotherapy
Upright position
Exercise
Long term follow up of ICU survivors

Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes