Steps to Recovery; Body weight-supported treadmill training for patients in the intensive care unit: a feasibility study
- Conditions
- Intensive Care Unit-Acquired Weakness (ICU-AW)10028302
- Registration Number
- NL-OMON43392
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Medical and surgical adult patients (*18 years) admitted to the ICU or the MICU of the AMC who have been mechanically ventilated *48 hours
Contra indications for physical therapy treatment according to the Evidence Statement for ICU physical therapy (Sommers. et. al. 2013):
o Recent myocardial ischemia
o Hart frequency < 40 or > 130
* Blood pressure:
o Map 110 mmHg
Pulse oxymetry: * 90%
Mechanical ventilation:
o FiO2 *0.6 (60%)
o PEEP* 10cm H2O
Breathing frequency:
o Frequency > 40 per minute
Low consciousness:
o RASS score: -4, -5, 3 or 4
Dose of inotropes:
o Dobutamine > 20 mcg/kg/min
o Dopamine > 10 mcg/kg/min
o Nor/adrenaline * 0.1 mcg/kg/min
Temperature:
o * 38.5 degrees Celsius
o *36 degrees
Other:
o Clinical observation by physical therapist: abnormal sweating, pain, fatigue
o Surgical contra-indications (i.e. instable fractures, bone flap, open abdomen or thorax)
o Presence of lines that prevent mobilization
* Imminent to death,
* Insufficient knowledge of the Dutch language,
* Neurological diseases and disorders as reason for ICU admission,
* One or more amputated lower extremities,
* Mental retardation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The study parameters to evaluate feasibility are:<br /><br>- Eligibility criteria, proportion of enrolled patients of those who are<br /><br>screened.<br /><br>- Number and reasons of planned sessions that could not be executed;<br /><br>- Number and reasons of sessions that could not be completed sessions;<br /><br>- (Serious) Adverse Events ((S)AE*s); Adverse events: near falls, wounds,<br /><br>dislocation of tubes or lines and Serious adverse events ((S)AEs);<br /><br>- Effort and costs: Number of staff needed; Treatment duration, including<br /><br>preparation time,<br /><br>- Fatigue (measured with Borg score before and after BWSTT, as part of ususal<br /><br>physiotherapy care), Patient satisfaction; Pain (measured with the numeric<br /><br>raitng scale, before and after BWSTT, Anxiety measured with the numeric raitng<br /><br>scale before and after BWSTT). </p><br>
- Secondary Outcome Measures
Name Time Method <p>The parameters to assess the effect size of potential outcome measures for the<br /><br>evaluation of BWSTT in ICU patients (future trial):<br /><br>- Acceleration of the first time to ambulation in ICU patients: Number of<br /><br>enrolled patients provided with the intervention who should not be able to walk<br /><br>without the intervention BWSTT<br /><br>- Walking capacity; Change in walking independence between start of BWSTT and<br /><br>at ICU /M-ICU discharge (measured with the De Morton Mobility Index (DEMMI) and<br /><br>Functional ambulation catergories (FAC) as part of usual physiotherapy care),<br /><br>Change in walking duration between start of BWSST and at ICU /M-ICU discharge,<br /><br>Body weight support (yes / no): change between first and last BWSTT<br /><br>- General muscle strength (MRC sum-score); change between start of BWSST and at<br /><br>ICU /M-ICU discharge as part of usual physiotherapy care. </p><br>