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ID
Source
Brief title
Health condition
Critical illness, early mobilisation, intensive care, ICU-aquired weakness, ambulation.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective is to investigate the effect of BWSTT in critically ill patients on time to functional ambulation
Secondary outcome
The secondary objectives of this study are to investigate the effects on other patient relevant outcome measures for the evaluation of BWSTT. These outcomes are walking capacity, walking distance, muscle strength, ICU acquired weakness, symptoms of post-traumatic stress, experienced exertion after physiotherapy (PT) intervention, training intensity (i.e. respiratory frequency, heart rate, blood pressure and oxygen saturation) of PT interventions, status of functional independency, functional ambulation, duration of mechanical ventilation, (Serious) Adverse Events), number of staff needed, time spent on intervention and patient satisfaction.
Background summary
Intensive Care Unit (ICU) acquired weakness results in difficult weaning from the ventilator and impedes functional recovery. Body weight supported treadmill training (BWSTT) has shown to be an effective modality for improving fitness, walking capacity and daily functioning in different populations but not for critically patients in an ICU. Our previous study showed that BWSTT is safe and feasible in an ICU setting. In this trial the effectiveness of BWSTT for critically ill patients in an ICU will be evaluated.
Study objective
Body weight-supported treadmill training during ICU and hospital stay leads to earlier independent functional ambulation compared to usual care.
Study design
Measurements of the primary outcome will be performed daily on the ICU en the regular wards but not on the weekends.
Intervention
Particlpants who are randomized into the lntervention group will receive BWSTT in addition to usual care. The BWSST intervention consists of walking on a treadmill while supported by a hamess. The intervention will be conducted according to the standardized operating procedure inciuding safety checks, transfers,
bodyweight support, treadmill speed and ambulation duration. The training will be inltiated during ICU stay and conducted by two experienced ICU physlotherapists, one who Is lnvolved in !hls study and a (intensive care or ward) physiotherapist who Is not involved in the study. BWSTT is provided on a daily basis (5 times a week, not during the weekend) in the ICU and continued on regular ward until a patient is able to ambulate with walking aid and physical support for balance assistance.
Marike van der Schaaf
Afdeling Revalidatie, Academisch Medisch Centrum, Universiteit van Amsterdam
Amsterdam 1100 DD
The Netherlands
020-5664421
m.vanderschaaf@amc.uva.nl
Marike van der Schaaf
Afdeling Revalidatie, Academisch Medisch Centrum, Universiteit van Amsterdam
Amsterdam 1100 DD
The Netherlands
020-5664421
m.vanderschaaf@amc.uva.nl
Inclusion criteria
Admission at ICU for medica! or surgical reasons, age 2:18, Mechanica! ventilatlon 2:48 hours, Meeting safety critiria vor rehabilitation according to the Evidence Statement for ICU physiotherapy (Sommers, 2016)
Exclusion criteria
Not meeting the safety criteria for rehabilitation according to the evidence statement for ICU physiotherapy. Imminent to death. Insufficient knowledge of the Dutch language. Unable to walk in the month prior to ICU admission. Neurological diseases and disorders as reason for ICU admission. One or more amputated lower extremities. Mental retardation
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6766 |
| NTR-old | NTR6943 |
| CCMO | NL63104.018.17 |
| OMON | NL-OMON48582 |