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

Primary Purpose

Critical Illness

Status
Completed
Phase
Not Applicable
Locations
Iceland
Study Type
Interventional
Intervention
Usual Physiotherapy
Enhanced Physiotherapy
Sponsored by
Landspitali University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring Intensive care unit, Physiotherapy, Upright position, Exercise, Long term follow up of ICU survivors

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Landspítali University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Physiotherapy

Enhanced Physiotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Length of ICU and hospital stay
Length of ICU and hospital stay will be measured in days and hours

Secondary Outcome Measures

Physical Function
Medical Research Council - sum-score
Physical function
Modified Barthel Index
Physical function
6 min walk test,
Health Related Quality of Life
Short Form-36v2,

Full Information

First Posted
March 12, 2012
Last Updated
November 27, 2015
Sponsor
Landspitali University Hospital
Collaborators
University of Iceland
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1. Study Identification

Unique Protocol Identification Number
NCT02301273
Brief Title
Being Awake, Upright and Moving as the Basis for Early ICU Physiotherapy
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 Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Landspitali University Hospital
Collaborators
University of Iceland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Intensive care unit, Physiotherapy, Upright position, Exercise, Long term follow up of ICU survivors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Physiotherapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Enhanced Physiotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Physiotherapy
Other Intervention Name(s)
Intensive care unit, Physiotherapy, Long term follow up of ICU survivors
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Enhanced Physiotherapy
Other Intervention Name(s)
Intensive care unit, Physiotherapy, Upright position, Exercise, Long term follow up of ICU survivors
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of ICU and hospital stay
Description
Length of ICU and hospital stay will be measured in days and hours
Time Frame
ICU discharge an expected average of 7 days / hospital discharge an expected average of 21 days
Secondary Outcome Measure Information:
Title
Physical Function
Description
Medical Research Council - sum-score
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
Title
Physical function
Description
Modified Barthel Index
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
Title
Physical function
Description
6 min walk test,
Time Frame
3,6,12 months after discharge from ICU
Title
Health Related Quality of Life
Description
Short Form-36v2,
Time Frame
0,3,6,12 months after discharge from ICU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Dean, PhD
Organizational Affiliation
University of Iceland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gísli H Sigurðsson, PhD
Organizational Affiliation
Landspítali University Hospital and University of Iceland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Þórarinn Sveinsson, PhD
Organizational Affiliation
University of Iceland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helga Jónsdóttir, PhD
Organizational Affiliation
University of Iceland
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alma Möller, PhD
Organizational Affiliation
Landspítali University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Landspítali University Hospital
City
Reykjavík
ZIP/Postal Code
108
Country
Iceland

12. IPD Sharing Statement

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

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