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STEPS To ICU Recovery


- candidate number28291
- NTR NumberNTR6943
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-dec-2017
- Secondary IDsNL63104.018.17 AMC MEC
- Public TitleSTEPS To ICU Recovery
- Scientific TitleBody weight-supported treadmill training for patients in the intensive care unit: a multicentre randomized controlled trial
- ACRONYMSTEPS Study
- hypothesisBody weight-supported treadmill training during ICU and hospital stay leads to earlier independent functional ambulation compared to usual care.
- Healt Condition(s) or Problem(s) studiedIntensive care, Critically ill, Frailty, Recovery
- Inclusion criteriaAdmission 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 criteriaNot 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
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 8-dec-2017
- planned closingdate1-apr-2020
- Target number of participants112
- InterventionsParticlpants 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.
- Primary outcomeThe primary objective is to investigate the effect of BWSTT in critically ill patients on time to functional ambulation
- Secondary outcomeThe 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.
- TimepointsMeasurements of the primary outcome will be performed daily on the ICU en the regular wards but not on the weekends.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. Marike van der Schaaf
- CONTACT for SCIENTIFIC QUERIESDr. Marike van der Schaaf
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Amsterdam, MotekForce link
- Publications
- Brief summaryIntensive 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.
- Main changes (audit trail)
- RECORD1-dec-2017 - 26-jan-2018


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