Back to resultsEarly In-bed Cycling in Critically Ill Children (wEECycle)
Primary Purpose
Critical Illness
Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
In-bed cycling
Usual Care
Sponsored by
About this trial
This is an interventional treatment trial for Critical Illness
Eligibility Criteria
Inclusion Criteria:
- age ≥ 3 years to < 18 years;
- Limited to bed-rest or bed mobility at time of screening
- expected PICU stay for an additional 48 hours minimum, at time of screening
- informed consent and or assent where appropriate;
- agreement of the most responsible PICU physician.
Exclusion Criteria:
- Contraindications: e.g. Hemodynamic instability, unstable or uncontrolled arrhythmia, ICP, unstable airway, unstable fractures/spine
- Contraindication to mobilizing upper/lower limbs, e.g. femoral sheath
- Cycle ergometer does not fit body dimensions
- Already mobilizing well/expected to mobilize out of bed within 24h
- not expected to survive current admission - i.e. predicted hospital mortality of > 90%;
Sites / Locations
- McMaster Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cycle ergometry
Usual care
Arm Description
Participants will receive In-bed cycling 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).
Usual care physiotherapy will be applied to patients in the control arm, according to the unit specific guidelines for early mobilization
Outcomes
Primary Outcome Measures
Feasibility - enrolment (75% consent rate target) and protocol adherence
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.
Secondary Outcome Measures
Adverse event rate
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02358577
Brief Title
Early In-bed Cycling in Critically Ill Children
Acronym
wEECycle
Official Title
Early Exercise in Critically Ill Youth and Children, a preLiminary Evaluation.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cycle ergometry
Arm Type
Experimental
Arm Description
Participants will receive In-bed cycling 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).
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Usual care physiotherapy will be applied to patients in the control arm, according to the unit specific guidelines for early mobilization
Intervention Type
Device
Intervention Name(s)
In-bed cycling
Other Intervention Name(s)
Cycle ergometry
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility - enrolment (75% consent rate target) and protocol adherence
Description
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
Secondary Outcome Measure Information:
Title
Adverse event rate
Description
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
7 days
Other Pre-specified Outcome Measures:
Title
Functional outcome (functional recovery, as measured by the Pediatric Overall Performance (POPC), the Pediatric Cerebral Performance Category (PCPC) Scores, and the Pediatric Disability Inventory)
Description
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
PCCU discharge, 3 and 6 months post PCCU discharge
Title
Workload (physiotherapist and nursing workload, as measured by set up and take down times)
Description
We will assess the physiotherapist and nursing workload in both groups
Time Frame
7 days
Title
Organ Dysfunction severity as measured by PELOD-2
Description
organ dysfunction severity progression will be measured by the Pediatric Logistic Organ Dysfunction score (PELOD-2)
Time Frame
30 days
Title
PCCU-acquired morbidities
Description
Incidence of PCCU-acquired weakness, pressure ulcers, delirium, sedation withdrawal and delirium
Time Frame
30 days
Title
Mortality
Description
PCCU, hospital, 3 and 6 month mortality
Time Frame
6 months
Title
Duration of Mechanical Ventilatory support
Description
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
Title
Length of stay
Description
The length of Paediatric intensive care unit and hospital stay, will be measured
Time Frame
30 days
Title
Caregiver perception
Description
Caregiver impressions of early mobilization interventions, and barriers and facilitators to early mobilization in critically ill children
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age ≥ 3 years to < 18 years;
Limited to bed-rest or bed mobility at time of screening
expected PICU stay for an additional 48 hours minimum, at time of screening
informed consent and or assent where appropriate;
agreement of the most responsible PICU physician.
Exclusion Criteria:
Contraindications: e.g. Hemodynamic instability, unstable or uncontrolled arrhythmia, ICP, unstable airway, unstable fractures/spine
Contraindication to mobilizing upper/lower limbs, e.g. femoral sheath
Cycle ergometer does not fit body dimensions
Already mobilizing well/expected to mobilize out of bed within 24h
not expected to survive current admission - i.e. predicted hospital mortality of > 90%;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Choong, MB, BCh, MSc
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster Children's Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
12. IPD Sharing Statement
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Early In-bed Cycling in Critically Ill Children
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