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

NCT02301273 | Completed

• 1 other identifier: 16.2011
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Keywords

Intensive care unit; Physiotherapy; Upright position; Exercise; Long term follow up of ICU survivors

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Physical Function

  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

  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

  3,6,12 months after discharge from ICU

• Health Related Quality of Life

  0,3,6,12 months after discharge from ICU

Study Arms (2)

Usual Physiotherapy

ACTIVE COMPARATOR

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

Enhanced Physiotherapy

EXPERIMENTAL

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

Interventions

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.

Also known as: Intensive care unit, Physiotherapy, Long term follow up of ICU survivors

Usual Physiotherapy

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.

Also known as: Intensive care unit, Physiotherapy, Upright position, Exercise, Long term follow up of ICU survivors

Enhanced Physiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Landspitali University Hospital: lead
• University of Iceland: collaborator

Study Sites (1)

Landspítali University Hospital

Reykjavik, 108, Iceland

Location

MeSH Terms

Conditions

Critical Illness; Motor Activity

Interventions

Intensive Care Units; Physical Therapy Modalities; Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Hospital Units; Health Facilities; Health Care Facilities Workforce and Services; Therapeutics; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 12, 2012
• First Posted: November 25, 2014
• Study Start: November 1, 2011
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: November 30, 2015

Record last verified: 2015-11

Locations

IC (1)