Early In-bed Cycling in Critically Ill Children

NCT02358577 | Completed Phase 1

• 1 other identifier: 14-530
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse event rate

  7 days

Other Outcomes (8)

• Functional outcome (functional recovery, 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)

  7 days

• Organ Dysfunction severity as measured by PELOD-2

  30 days

Study Arms (2)

Cycle ergometry

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

Usual care physiotherapy will be applied to patients in the control arm, according to the unit specific guidelines for early mobilization

Other: Usual Care

Interventions

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.

Also known as: Cycle ergometry

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.

Usual care

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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%;

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster Children's Hospital

Hamilton, Ontario, L8S 4K1, Canada

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen Choong, MB, BCh, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2015
• First Posted: February 9, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 20, 2018

Record last verified: 2018-08

Locations

CA (1)