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NCT Number: NCT02301273

Being Awake, Upright and Moving as the Basis for Early 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.

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Key information

Conditions

Critical Illness Behavior Disease Attributes Motor Activity Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Landspítali University Hospital

Reykjavik, 108, Iceland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Physiotherapy

Other

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

Enhanced Physiotherapy

Other

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 outcomes

  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 outcomes

  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,

Sponsors and collaborators

Lead sponsor

Landspitali University Hospital

Other

Collaborators

  • University of Iceland

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 25, 2014
Registry last updated
Nov 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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