Early In-bed Cycling in Critically Ill Children (wEECycle)

Early Exercise in Critically Ill Youth and Children, a preLiminary Evaluation.

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Device: In-bed cycling; Other: Usual Care

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4K1
      • McMaster Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. age ≥ 3 years to < 18 years;
2. Limited to bed-rest or bed mobility at time of screening
3. expected PICU stay for an additional 48 hours minimum, at time of screening
4. informed consent and or assent where appropriate;
5. agreement of the most responsible PICU physician.

Exclusion Criteria:

1. Contraindications: e.g. Hemodynamic instability, unstable or uncontrolled arrhythmia, ICP, unstable airway, unstable fractures/spine
2. Contraindication to mobilizing upper/lower limbs, e.g. femoral sheath
3. Cycle ergometer does not fit body dimensions
4. Already mobilizing well/expected to mobilize out of bed within 24h
5. not expected to survive current admission - i.e. predicted hospital mortality of > 90%;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cycle ergometry; 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).	Device: In-bed cycling; 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
Active Comparator: Usual care; Usual care physiotherapy will be applied to patients in the control arm, according to the unit specific guidelines for early mobilization	Other: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	7 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome (functional recovery, as measured by the Pediatric Overall Performance (POPC), the Pediatric Cerebral Performance Category (PCPC) Scores, and the Pediatric Disability Inventory)	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)	PCCU discharge, 3 and 6 months post PCCU discharge
Workload (physiotherapist and nursing workload, as measured by set up and take down times)	We will assess the physiotherapist and nursing workload in both groups	7 days
Organ Dysfunction severity as measured by PELOD-2	organ dysfunction severity progression will be measured by the Pediatric Logistic Organ Dysfunction score (PELOD-2)	30 days
PCCU-acquired morbidities	Incidence of PCCU-acquired weakness, pressure ulcers, delirium, sedation withdrawal and delirium	30 days
Mortality	PCCU, hospital, 3 and 6 month mortality	6 months
Duration of Mechanical Ventilatory support	The number of days on mechanical ventilatory support, and the number of days alive and free of mechanical ventilatory support at 30 days	30 days
Length of stay	The length of Paediatric intensive care unit and hospital stay, will be measured	30 days
Caregiver perception	Caregiver impressions of early mobilization interventions, and barriers and facilitators to early mobilization in critically ill children	7 days

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Karen Choong, MB, BCh, MSc, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: January 22, 2015
• First Submitted That Met QC Criteria: February 3, 2015
• First Posted (Estimate): February 9, 2015

Study Record Updates

• Last Update Posted (Actual): August 20, 2018
• Last Update Submitted That Met QC Criteria: August 16, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 14-530