The aim of this study is to conduct a pilot study of weight-supported ambulation training in ICU patients and to assess its feasibility of the use in daily practice, and to obtain information for the development of a randomized clinical trial for…
ID
Source
Brief title
Condition
- Muscle disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study parameters to evaluate feasibility are:
- Eligibility criteria, proportion of enrolled patients of those who are
screened.
- Number and reasons of planned sessions that could not be executed;
- Number and reasons of sessions that could not be completed sessions;
- (Serious) Adverse Events ((S)AE*s); Adverse events: near falls, wounds,
dislocation of tubes or lines and Serious adverse events ((S)AEs);
- Effort and costs: Number of staff needed; Treatment duration, including
preparation time,
- Fatigue (measured with Borg score before and after BWSTT, as part of ususal
physiotherapy care), Patient satisfaction; Pain (measured with the numeric
raitng scale, before and after BWSTT, Anxiety measured with the numeric raitng
scale before and after BWSTT).
Secondary outcome
The parameters to assess the effect size of potential outcome measures for the
evaluation of BWSTT in ICU patients (future trial):
- Acceleration of the first time to ambulation in ICU patients: Number of
enrolled patients provided with the intervention who should not be able to walk
without the intervention BWSTT
- Walking capacity; Change in walking independence between start of BWSTT and
at ICU /M-ICU discharge (measured with the De Morton Mobility Index (DEMMI) and
Functional ambulation catergories (FAC) as part of usual physiotherapy care),
Change in walking duration between start of BWSST and at ICU /M-ICU discharge,
Body weight support (yes / no): change between first and last BWSTT
- General muscle strength (MRC sum-score); change between start of BWSST and at
ICU /M-ICU discharge as part of usual physiotherapy care.
Background summary
Intensive Care Units (ICUs) in the Netherlands admit over 82,000 patients every
year 1. The survival rate of critically ill patients admitted to the ICU has
significantly increased through improvements in medical care. Approximately 50%
of these critically ill patients are at risk of developing ICU-Acquired
Weakness (ICU-AW) 2,3. ICU-AW results in difficult weaning from the ventilator
and impedes recovery of muscle strength, muscular endurance and aerobic
capacity and that contributes to a longer hospital stay, a decrease in
functioning and a reduced quality of life after ICU admission.
There is increasing evidence that early mobilization, activation and ambulation
of patients admitted to the ICU may influence or even prevent long term
physical impairments.
In the AMC currently ICU patients are mobilized in several ways from standing
and sitting, biking on a cycle ergometer with legs or arms while in bed or in
a chair, and walking, whenever feasible. However, walking with ICU patients is
difficult in practice, because of the reduced muscle strength, as well as the
limited length of the infusion lines, drains and the tube of mechanical
ventilation.
Body weight-supported treadmill training (BWSTT) has shown to be an effective
modality for improving fitness, walking capacity and daily functioning in
different rehabilitation populations with muscle weakness.
BWSTT has not been used in ICU patients before, but might be able to facilitate
ambulation in an early phase, even before independent walking is attained.
Moreover, ICU patients are attached to lines, drains and mechanical
ventilation, which are necessary for monitoring and treatment. The premise is
that early ambulation training in ICU patients supported by BWSTT will
facilitate the first time to ambulation and improve functional status at ICU
discharge in critically ill patients.
Study objective
The aim of this study is to conduct a pilot study of weight-supported
ambulation training in ICU patients and to assess its feasibility of the use in
daily practice, and to obtain information for the development of a randomized
clinical trial for the evaluation of the effect of BWSTT in ICU patients.
Study design
A pilot interventional single group design.
Intervention
A mobile treadmill with weight bearing utility will be used for BSTT in ICU
patients. The body weight-supported treadmill enables early ambulation in
patients with insufficient motor control or strength to fully bear weight.
For study participants, 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 (SOP) with respect to safety
checks, transfers, bodyweight support, treadmill speed and ambulation duration.
The training will be conducted by two experienced ICU physiotherapists involved
in this study and trained and skilled for this intervention as described in the
SOP. BWSTT is provided on a daily basis (5 times a week, not during the
weekend) in the ICU or MICU.
Study burden and risks
Negelectable.
The burden and risks associated with the intervention BWSTT is comparable to
that of usual physiotherapy treatment.
The majority of outcomes are currently measured and recorded as part of the
current physiotherapy treatment (as described in the Evidence Statement for ICU
physiotherapy; Sommers 2013).
Additional measurements are: patient satisfaction (numeric rating scale using
symbols), pain, anxiety (numeric rating scale).
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Medical and surgical adult patients (*18 years) admitted to the ICU or the MICU of the AMC who have been mechanically ventilated *48 hours
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56342.018.16 |