An observational study in Critical Illness, Quality of Life and Physical Activity, sponsored by Zealand University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-07-02.
Sponsored by Zealand University Hospital · Observational
This study aims to investigate whether an actigraph, measuring in-hospital activity, used for a week after discharge from the ICU at Zealand University Hospital Køge, can predict physical function at three-month follow up.
The hospital activity will be measured with actigraphy, a measurement tool that quantifies activity level. The activity will be measured for 7 days after ICU discharge. The actigraph is to be worn as a bracelet.
The physical function will be measured with Chelsea Critical Care Physical Assessment Tool (CPAx). CPAx is assessed at ICU discharge and after three months.
Treatment at an Intensive Care Unit (ICU) is often needed for the survival of critically ill patients, but it can take a long time to recover. A number of high quality studies have shown that patients experience functional impairments for a long period after discharge, even for years.
These patients may suffer from a number of other negative influences of their critical illness and ICU stay, e.g. memory problems, episodes of depression, cognitive dysfunction and sleeping disorders. These symptoms are seen in both medical and surgical patients and has been named the Post Intensive Care Syndrome.
Physical rehabilitation is important and must start already during admission, in order to regain some of the function and independence of the patients. This has a well documented effect on both mental and physical wellbeing.
Actigraphy is a newer way of quantifying the activity level continuously. It is validated and has been used in the ICU to assess agitation and sedation and in an oncological, surgical and even an ICU population to assess sleep.
It is easy to use, non-invasive and inexpensive. It is worn like a bracelet and doesn't impair the patients mobility or ambulation.
Another issue when evaluating physical impairments is the choice of method for assessing physical function. For this study, the investigators use the Chelsea Critical Care Physical Assessment Tool (CPAx) as it has good validity and clinimetric properties and is easy to use. Also, it can be done as part of the daily training as it is developed specifically for the ICU.
The aim of this study is to investigate how the in-hospital activity level of patients after ICU discharge is associated with their physical function at three months post discharge.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 40 is below the median of 130 across 867 observational studies indexed under Critical Illness.
Browse Critical Illness studies →Zealand University Hospital is the lead sponsor of 234 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients admitted to the ICU at Zealand University Hospital, Køge, in the study period
Exclusion Criteria:
The association between actigraph levels and CPAx at three months after discharge from ICU
The association between actigraph levels and CPAx score (from 0 to 50 points)
Time frame: 3 months after discharge from intensive care unit
CPAx at discharge from ICU
CPAx score (from 0 to 50 points)
Time frame: Within 24 hours of discharge from intensive care unit
Activity measured with actigraph during one week after ICU-discharge
Activity measured with an actigraph watch placed on the patients' wrist
Time frame: One week after discharge from ICU
Association between early activity level measured with actigraphy for 7 days and SF 36 at three months after discharge from ICU
The association between actigraph levels and SF-36 score
Time frame: 3 months after discharge from intensive care unit
Association between early activity level measured with actigraphy for 7 days and Hospital Anxiety and Depression Scale (HADS) at three months after discharge from ICU
The association between actigraph levels and HADS score (from 0 to 42 points)
Time frame: 3 months after discharge from intensive care unit
Association between early activity level measured with actigraphy for 7 days and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at three months after discharge from ICU
The association between actigraph levels and RBANS score
Time frame: 3 months after discharge from intensive care unit
Association between early activity level measured with actigraphy for 7 days and mortality within hospital stay, after ICU discharge
The association between actigraph levels and hospital mortality
Time frame: The period within hospital stay, after intensive care unit discharge
Association between early activity level measured with actigraphy for 7 days and mortality within 90 days after ICU discharge
The association between actigraph levels and 90-day mortality
Time frame: 3 months after discharge from intensive care unit
Association between early activity level measured with actigraphy for 7 days and consumption of opioids (strong/weak) at 90 days follow up.
The association between actigraph levels and opioid-consumtion (morphine-equivalents)
Time frame: 3 months after discharge from intensive care unit
Plan to share: No
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Zealand University Hospital