McMaster Children's Hospital
Hamilton, Ontario, L8S 4K1, Canada
NCT Number: NCT02358577
To evaluate the feasibility of conducting a randomized controlled trial (RCT) evaluating the efficacy of early in-bed cycling in addition to usual care physiotherapy, compared to usual care physiotherapy, on functional recovery in critically ill children.
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Notify Me3 year–17 year
All sexes
Interventional
Phase 1 / Phase 2
Hamilton, Ontario, L8S 4K1, Canada
This is a single centre, Pilot RCT that will evaluate in-bed cycling in addition to usual care physiotherapy, compared to usual care physiotherapy, on functional recovery in critically ill children. We will conduct a qualitative substudy to evaluate caregiver impressions of the intervention, and to understand barriers and facilitators to implementing early mobilization in critically ill children.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In-bed cycling will be applied using a cycle ergometer (RT300 Supine Cycle Ergometer) for 30 minutes per day in addition to Usual Care, until the physiotherapist deems that the patient is mobilizing well, or a maximum of 7 days (whichever comes first). This cycle ergometer is specifically designed for pediatric use, and can be applied to facilitate lower or upper limb cycling. The intervention will be applied by a trained physiotherapist and/or clinician. Pre-defined Safety Criteria for interrupting or aborting the intervention will be observed. Qualitative interviews will be conducted with a health care provider, the patient where possible, and a family caregiver following the intervention period.
Other names: Cycle ergometry
Usual care physiotherapy will be applied to patients in the control arm, according to the unit specific guidelines for early mobilization. Qualitative interviews will be conducted with a health care provider, the patient where possible, and a family caregiver following the intervention period.
Time frame: 7 days
Feasibility is defined as the ability to screen and enrol eligible patients (75% consent rate target).Protocol adherence will be defined as the ability to apply in-bed cycling intervention within 24 hours of consent, and the ability to apply 30 minutes of in-bed cycling daily during week days. We will also measure the rates and reasons for protocol suspensions, violations and study withdrawal.
Time frame: 7 days
Adverse event rates, physiological parameters prior to, during and after the intervention, discomfort or pain related to the study intervention (as measured by validated pediatric scores).
Time frame: PCCU discharge, 3 and 6 months post PCCU discharge
We will assess functional recovery at 3 and 6 months (as measured by the Pediatric Overall Performance (POPC), the Pediatric Cerebral Performance Category (PCPC) Scores, and the Pediatric Disability Inventory)
Time frame: 7 days
We will assess the physiotherapist and nursing workload in both groups
Time frame: 30 days
organ dysfunction severity progression will be measured by the Pediatric Logistic Organ Dysfunction score (PELOD-2)
Time frame: 30 days
Incidence of PCCU-acquired weakness, pressure ulcers, delirium, sedation withdrawal and delirium
Time frame: 6 months
PCCU, hospital, 3 and 6 month mortality
Time frame: 30 days
The number of days on mechanical ventilatory support, and the number of days alive and free of mechanical ventilatory support at 30 days
Time frame: 30 days
The length of Paediatric intensive care unit and hospital stay, will be measured
Time frame: 7 days
Caregiver impressions of early mobilization interventions, and barriers and facilitators to early mobilization in critically ill children
McMaster University
Other
Early Exercise in Critically Ill Youth and Children, a preLiminary Evaluation.
Acronym: wEECycle
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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