The objective of this study is to investigate the effect of BWSTT in critically ill patients on time to independent functional ambulation as compared to usual care.
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The number of days to independent ambulation as measured with the Functional
Ambulation Categories (FAC *3).
The FAC is recorded daily as part of physiotherapy treatment.
Secondary outcome
The following parameters are recorded as part of daily physiotherapy care and
will be used as secundairy outcome measures: walking distance, overall muscle
strength, fatigue after physiotherapy, physiological response to exercise
(heart rate, respiratory frequency, blood pressure, saturation), functional
status, walking capacity, duration of treatment, number of staff needed,
duration of mechanical ventilation, ICU acquired weakness, time to start of
walking training..
The following parameters will be recorded additionally to usual care for the
purpose of this study: anxiety, pain and satisfaction (numeric rating scale)
and symptoms of post traumatic stress (PCL-5).
Background summary
Every year more than 85.000 patients are admitted to Dutch Intensive Care Units
(ICU's). Many patients develop ICU acquired weakness. ICU-AW is associated with
prolonged mechanical ventilation, poor functional recovery, prolonged hospital
stay en decreased quality of life after hospital discharge. Decreased walking
capacity may exist for years after a stay in the ICU.
The departments of Rehabilitation and Intensive Care Medicine developed in
collaboration with Motek ForceLink a prototype transportable treadmill with
weight bearing facility. This novel technology enables ICU patients with muscle
weakness to walk at the bedside without interuption of medical treatment
(ventilation, dialysis, medication etc) and monitoring of vital signs.
Our pilot study showed that body weight supported treadmill training is
feasible and safe in ICU patients.
Study objective
The objective of this study is to investigate the effect of BWSTT in critically
ill patients on time to independent functional ambulation as compared to usual
care.
Study design
A randomized controlled trial
Intervention
Participants who are randomized into the intervention group will receive BWSTT
in addition to usual care. The BWSST intervention consists of walking on a
treadmill while supported by a harness. The intervention will be conducted
according to the standardized operating procedure including safety checks,
transfers, bodyweight support, treadmill speed and ambulation duration. The
training will be initiated during ICU stay and conducted by two experienced ICU
physiotherapists, one who is involved in this 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 (FAC 2 or higher).
When the BWSTT intervention is stopped (FAC 2 or higher), physiotherapy as
usual care will be provided from that point on.
Study burden and risks
Moderate risk due to the use of a medical device. Our pilot study demonstrated
that BWSTT is feasible and safe in critically ill intenisive care patients. No
additional risk to usual physiotherapy for ICU patients.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Admission at ICU for medical or surgical reasons, age *18, Mechanical
ventilation *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 (protocol page 7; exclusion criteria)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL63104.018.17 |
| Other | NTR: 6943 |
| OMON | NL-OMON20691 |