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Completed

NCT Number: NCT02358577

Early In-bed Cycling in Critically Ill Children

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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Key information

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%;

Treatment and study plan

In-bed cycling

Device

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

Other

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 outcomes

  1. Feasibility - enrolment (75% consent rate target) and protocol adherence

    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.

Secondary outcomes

  1. Adverse event rate

    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).

Other outcomes

  1. Functional outcome (functional recovery, 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

    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)

  2. Workload (physiotherapist and nursing workload, as measured by set up and take down times)

    Time frame: 7 days

    We will assess the physiotherapist and nursing workload in both groups

  3. Organ Dysfunction severity as measured by PELOD-2

    Time frame: 30 days

    organ dysfunction severity progression will be measured by the Pediatric Logistic Organ Dysfunction score (PELOD-2)

  4. PCCU-acquired morbidities

    Time frame: 30 days

    Incidence of PCCU-acquired weakness, pressure ulcers, delirium, sedation withdrawal and delirium

  5. Mortality

    Time frame: 6 months

    PCCU, hospital, 3 and 6 month mortality

  6. Duration of Mechanical Ventilatory support

    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

  7. Length of stay

    Time frame: 30 days

    The length of Paediatric intensive care unit and hospital stay, will be measured

  8. Caregiver perception

    Time frame: 7 days

    Caregiver impressions of early mobilization interventions, and barriers and facilitators to early mobilization in critically ill children

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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

Acronym: wEECycle

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 9, 2015
Registry last updated
Aug 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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