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

McMaster University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Critical Illness

Treatments: Other: Usual Care; Device: In-bed cycling

Study type: Interventional

Funder types: Other

Identifiers

NCT02358577

14-530

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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%;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Cycle ergometry

Experimental group

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).

Treatment:

Device: In-bed cycling

Usual care

Active Comparator group

Description:

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

Treatment:

Other: Usual Care