Critical IllnessNCT02301273
Being Awake, Upright and Moving as the Basis for Early ICU Physiotherapy
A study testing Usual Physiotherapy and Enhanced Physiotherapy in people with Critical Illness, run by Landspitali University Hospital at 1 site in Iceland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Critical Illness
- What is being tested?
- Usual Physiotherapy and Enhanced Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIceland
- Study dates
- Nov 2011to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Critical Illness
- Being tested
- Usual Physiotherapy, Enhanced Physiotherapy
- Keywords
- Intensive care unit, Physiotherapy, Upright position, Exercise, Long term follow up of ICU survivors
- Medical subject headings
- Critical Illness, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual PhysiotherapyOther
Also called Intensive care unit, Physiotherapy, Long term follow up of ICU survivors
- 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.
Enhanced PhysiotherapyOther
Also called Intensive care unit, Physiotherapy, Upright position, Exercise
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Enhanced Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of ICU and hospital stay
Length of ICU and hospital stay will be measured in days and hours
Measured: ICU discharge an expected average of 7 days / hospital discharge an expected average of 21 days
Secondary outcomes (4)
Physical Function
Medical Research Council - sum-score
Measured: 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
Measured: 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,
Measured: 3,6,12 months after discharge from ICU
Health Related Quality of Life
Short Form-36v2,
Measured: 0,3,6,12 months after discharge from ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startNov 2011
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Landspitali University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Iceland
- Responsible party
- Principal investigator, Olof Ragna Amundadottir, Landspitali University Hospital
- Investigators
- Elizabeth Dean, PhD, Study chair, University of IcelandGísli H Sigurðsson, PhD, Study chair, Landspítali University Hospital and University of IcelandÞórarinn Sveinsson, PhD, Study chair, University of IcelandHelga Jónsdóttir, PhD, Study chair, University of IcelandAlma Möller, PhD, Study chair, Landspítali University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301273
- Sponsor's protocol ID
- 16.2011
- Status last verified
- Nov 2015
- First submitted
- 12 Mar 2012
- Last updated
- 30 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Being Awake, Upright and Moving as the Basis for Early ICU Physiotherapy: Comparison of Patient Outcomes Between Enhanced and Conventional ICU Physiotherapy
- ClinicalTrials.gov ID
- NCT02301273
- Acronym / sponsor ID
- 16.2011
- Conditions
- Critical Illness
- Keywords
- Intensive care unit, Physiotherapy, Upright position, Exercise, Long term follow up of ICU survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Landspitali University HospitalUniversity, hospital or other
- Collaborators
- University of Iceland
- Study start
- Nov 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Physiotherapy | Active comparator | Other: Usual PhysiotherapyPatients 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. |
| Enhanced Physiotherapy | Experimental | Other: Enhanced PhysiotherapyPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- -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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual PhysiotherapyAlso: Intensive care unit, Physiotherapy, Long term follow up of ICU survivorso 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 PhysiotherapyAlso: Intensive care unit, Physiotherapy, Upright position, Exerciseo 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 |
Primary outcome
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
4 secondary outcomes
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
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
Physical function
Time frame: 3,6,12 months after discharge from ICU
Health Related Quality of Life
Time frame: 0,3,6,12 months after discharge from ICU
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Dean, PhD study chair
University of Iceland
Gísli H Sigurðsson, PhD study chair
Landspítali University Hospital and University of Iceland
Þórarinn Sveinsson, PhD study chair
University of Iceland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual Physiotherapy and Enhanced Physiotherapy in people with Critical Illness, run by Landspitali University Hospital at 1 site in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of ICU and hospital stay (time frame: ICU discharge an expected average of 7 days / hospital discharge an expected average of 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2015.