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

Being Awake, Upright and Moving as the Basis for Early ICU Physiotherapy: Comparison of Patient Outcomes Between Enhanced and Conventional ICU Physiotherapy

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Other: Usual Physiotherapy; Other: Enhanced Physiotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iceland
  • Reykjavík, Iceland, 108
    • Landspitali University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: Physiotherapy; Intensive care unit; 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: Exercise; Physiotherapy; Intensive care unit; Long term follow up of ICU survivors; Upright position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of ICU and hospital stay	Length of ICU and hospital stay will be measured in days and hours	ICU discharge an expected average of 7 days / hospital discharge an expected average of 21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Function	Medical Research Council - sum-score	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
Physical function	Modified Barthel Index	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
Physical function	6 min walk test,	3,6,12 months after discharge from ICU
Health Related Quality of Life	Short Form-36v2,	0,3,6,12 months after discharge from ICU

Collaborators and Investigators

• Sponsor: Landspitali University Hospital
• Collaborators: University of Iceland
• Investigators: Study Chair: Þórarinn Sveinsson, PhD, University of Iceland; Study Chair: Elizabeth Dean, PhD, University of Iceland; Study Chair: Gísli H Sigurðsson, PhD, Landspítali University Hospital and University of Iceland; Study Chair: Helga Jónsdóttir, PhD, University of Iceland; Study Chair: Alma Möller, PhD, Landspitali University Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: March 12, 2012
• First Submitted That Met QC Criteria: November 21, 2014
• First Posted (Estimate): November 25, 2014

Study Record Updates

• Last Update Posted (Estimate): November 30, 2015
• Last Update Submitted That Met QC Criteria: November 27, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Exercise; Intensive care unit; Physiotherapy; Upright position; Long term follow up of ICU survivors
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 16.2011