Early Exercise in Critically Ill Youth and Children, a preLiminary Evaluation.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Critical Illness
- Sponsor
- McMaster University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Feasibility - enrolment (75% consent rate target) and protocol adherence
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
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%;
Outcomes
Primary Outcomes
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
- Adverse event rate(7 days)