Early Rehabilitation in Critically Ill Children Pilot Study (WeeHab in PCCU)
Critically ill patients are often confined to bedrest, because of the nature of their illness. However, it has now been shown that prolonged bedrest and immobility, particularly in critically ill adults and children, can lead to serious outcomes such as muscle weakness and prolonged stay in the intensive care unit (ICU). Research in adults has demonstrated that preventing immobility and introducing exercise and rehabilitation in adult patients early during their ICU illness can prevent these serious outcomes, reduce the duration of hospital stay, and enhance their recovery after they leave the ICU. The purpose of our research is to investigate if early mobilization and rehabilitation can also be performed in critically ill children, and eventually evaluate this results in beneficial outcomes in these children, as it has been shown to be in adults. However, given that children are not the same as adults, but have varying abilities to understand and participate in activities when they are sick, the investigators first have to evaluate the most appropriate and safe ways of helping children "exercise" while they are in the ICU. This objective of this study is to evaluate if 2 methods of rehabilitation (a stationary bike and interactive video game) can be implemented in critically ill children. These methods have been used in hospitalized children and in critically ill adults. The investigators will evaluate if these methods are safe for critically ill children.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Early Rehabilitation in Critically Ill Children, a Pilot Study|
- Feasibility [ Time Frame: 2 days ] [ Designated as safety issue: No ]
The primary outcome of interest in this pilot study is feasibility. Feasibility is defined as follows:
- The ability to screen and enroll eligible patients - enrolment rate of at least 70% of those approached for consent (benchmark for PCCU trials)
- Time to application of acute rehabilitation intervention.
- Protocol adherence - a protocol violation rate of < 10%.
- Safety [ Time Frame: Study period ] [ Designated as safety issue: Yes ]The proportion of patients with adverse events attributable to the rehabilitation intervention (e.g. cardiorespiratory events, tube dislodgement's).
- Change in activity from baseline [ Time Frame: From baseline to end of intervention ] [ Designated as safety issue: No ]Change in activity from baseline, during and following the intervention as measured by accelerometer, and patient
- Caregiver/user perception of intervention [ Time Frame: At end of study period ] [ Designated as safety issue: No ]Self-administered survey of caregiver and or user, to evaluate perceptions of intervention
|Study Start Date:||February 2012|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
Experimental: Single Arm: Study Intervention
Cycle ergometry and/or Interactive video-game
Device: Early Rehabilitation intervention
In this prospective cohort pilot study, eligible critically ill children aged 3 to 17 years will receive in addition to their usual care, a passive and/or an active mobility intervention, depending on their level of consciousness or cognitive ability. The active intervention will consist of an interactive video game (X Box 360 Kinect), while a cycle ergometer will be used as the passive intervention. The mobility interventions will be applied for a minimum of 10 minutes on day 1, and 20 minutes on day 2. For unconscious patients, or eligible patients who cognitively impaired, the passive intervention will be applied. As soon as the patient is conscious and cooperative, the active intervention will be applied.
The primary outcomes of interest in this pilot study are feasibility (defined as the ability to screen and enroll patients, consent rate and protocol adherence). Secondary outcomes of interest include safety outcomes, clinical outcomes and patient and caregiver satisfaction with the intervention.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531816
|McMaster Children's Hospital|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Principal Investigator:||Karen Choong, MB, BCh, MSc||McMaster University|